{"id":615,"date":"2016-11-12T07:57:37","date_gmt":"2016-11-12T06:57:37","guid":{"rendered":"https:\/\/cegat.net\/web\/en\/for-physicians\/einschraenkungen-des-harmony-tests\/"},"modified":"2026-02-25T13:06:26","modified_gmt":"2026-02-25T12:06:26","slug":"limitations-of-the-harmony-test","status":"publish","type":"page","link":"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/","title":{"rendered":"Limitations of the Harmony\u00ae Test"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"615\" class=\"elementor elementor-615\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7d0dd9f elementor-hidden-mobile elementor-hidden-tablet elementor-section-content-middle elementor-section-stretched elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7d0dd9f\" data-element_type=\"section\" data-e-type=\"section\" data-settings='{\"background_background\":\"classic\",\"stretch_section\":\"section-stretched\"}'>\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ea801fb\" data-id=\"ea801fb\" data-element_type=\"column\" data-e-type=\"column\" data-settings='{\"background_background\":\"classic\"}'>\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1601fd0 elementor--h-position-right elementor--v-position-middle elementor-widget elementor-widget-slides\" data-id=\"1601fd0\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings='{\"autoplay_speed\":8000,\"transition\":\"fade\",\"navigation\":\"none\",\"autoplay\":\"yes\",\"pause_on_hover\":\"yes\",\"pause_on_interaction\":\"yes\",\"infinite\":\"yes\",\"transition_speed\":500}' data-widget_type=\"slides.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-swiper\">\n\t\t\t\t\t<div class=\"elementor-slides-wrapper elementor-main-swiper swiper\" role=\"region\" aria-roledescription=\"carousel\" aria-label=\"Slides\" dir=\"ltr\" data-animation=\"fadeInRight\">\n\t\t\t\t<div class=\"swiper-wrapper elementor-slides\">\n\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-repeater-item-3ab48d5 swiper-slide\" role=\"group\" aria-roledescription=\"slide\"><div class=\"swiper-slide-bg\"><\/div><div class=\"swiper-slide-inner\"><div class=\"swiper-slide-contents\"><div class=\"elementor-slide-heading\">Highest Standard.<\/div><\/div><\/div><\/div><div class=\"elementor-repeater-item-1edd39b swiper-slide\" role=\"group\" aria-roledescription=\"slide\"><div class=\"swiper-slide-bg\"><\/div><div class=\"swiper-slide-inner\"><div class=\"swiper-slide-contents\"><div class=\"elementor-slide-heading\">For your patients.<\/div><\/div><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-754b678 elementor-hidden-mobile elementor-hidden-tablet elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"754b678\" data-element_type=\"section\" data-e-type=\"section\" data-settings='{\"background_background\":\"gradient\"}'>\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-68cb677\" data-id=\"68cb677\" data-element_type=\"column\" data-e-type=\"column\" data-settings='{\"background_background\":\"classic\"}'>\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2c92fc7 elementor-hidden-mobile elementor-section-content-middle elementor-section-stretched elementor-hidden-desktop elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2c92fc7\" data-element_type=\"section\" data-e-type=\"section\" data-settings='{\"background_background\":\"classic\",\"stretch_section\":\"section-stretched\"}'>\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ffb0d15\" data-id=\"ffb0d15\" data-element_type=\"column\" data-e-type=\"column\" data-settings='{\"background_background\":\"classic\"}'>\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-8ad32ab elementor--h-position-right elementor--v-position-middle elementor-widget elementor-widget-slides\" data-id=\"8ad32ab\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings='{\"autoplay_speed\":8000,\"transition\":\"fade\",\"navigation\":\"none\",\"autoplay\":\"yes\",\"pause_on_hover\":\"yes\",\"pause_on_interaction\":\"yes\",\"infinite\":\"yes\",\"transition_speed\":500}' data-widget_type=\"slides.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-swiper\">\n\t\t\t\t\t<div class=\"elementor-slides-wrapper elementor-main-swiper swiper\" role=\"region\" aria-roledescription=\"carousel\" aria-label=\"Slides\" dir=\"ltr\" data-animation=\"fadeInRight\">\n\t\t\t\t<div class=\"swiper-wrapper elementor-slides\">\n\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-repeater-item-3ab48d5 swiper-slide\" role=\"group\" aria-roledescription=\"slide\"><div class=\"swiper-slide-bg\"><\/div><div class=\"swiper-slide-inner\"><div class=\"swiper-slide-contents\"><div class=\"elementor-slide-heading\">Highest Standard.<\/div><\/div><\/div><\/div><div class=\"elementor-repeater-item-1edd39b swiper-slide\" role=\"group\" aria-roledescription=\"slide\"><div class=\"swiper-slide-bg\"><\/div><div class=\"swiper-slide-inner\"><div class=\"swiper-slide-contents\"><div class=\"elementor-slide-heading\">For your patients.<\/div><\/div><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3995598 elementor-hidden-mobile elementor-section-content-middle elementor-hidden-desktop elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3995598\" data-element_type=\"section\" data-e-type=\"section\" data-settings='{\"background_background\":\"gradient\"}'>\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-e461f35\" data-id=\"e461f35\" data-element_type=\"column\" data-e-type=\"column\" data-settings='{\"background_background\":\"classic\"}'>\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ac87b28 elementor-hidden-tablet elementor-section-content-middle elementor-section-stretched elementor-hidden-desktop elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ac87b28\" data-element_type=\"section\" data-e-type=\"section\" data-settings='{\"background_background\":\"classic\",\"stretch_section\":\"section-stretched\"}'>\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-a756fc3\" data-id=\"a756fc3\" data-element_type=\"column\" data-e-type=\"column\" data-settings='{\"background_background\":\"classic\"}'>\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5a03de9 elementor--h-position-right elementor--v-position-middle elementor-widget elementor-widget-slides\" data-id=\"5a03de9\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings='{\"autoplay_speed\":8000,\"transition\":\"fade\",\"navigation\":\"none\",\"autoplay\":\"yes\",\"pause_on_hover\":\"yes\",\"pause_on_interaction\":\"yes\",\"infinite\":\"yes\",\"transition_speed\":500}' data-widget_type=\"slides.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-swiper\">\n\t\t\t\t\t<div class=\"elementor-slides-wrapper elementor-main-swiper swiper\" role=\"region\" aria-roledescription=\"carousel\" aria-label=\"Slides\" dir=\"ltr\" data-animation=\"fadeInRight\">\n\t\t\t\t<div class=\"swiper-wrapper elementor-slides\">\n\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-repeater-item-3ab48d5 swiper-slide\" role=\"group\" aria-roledescription=\"slide\"><div class=\"swiper-slide-bg\"><\/div><div class=\"swiper-slide-inner\"><div class=\"swiper-slide-contents\"><div class=\"elementor-slide-heading\">Highest Standard.<\/div><\/div><\/div><\/div><div class=\"elementor-repeater-item-1edd39b swiper-slide\" role=\"group\" aria-roledescription=\"slide\"><div class=\"swiper-slide-bg\"><\/div><div class=\"swiper-slide-inner\"><div class=\"swiper-slide-contents\"><div class=\"elementor-slide-heading\">For your patients.<\/div><\/div><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-d2aa20f elementor-hidden-tablet elementor-section-content-middle elementor-hidden-desktop elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d2aa20f\" data-element_type=\"section\" data-e-type=\"section\" data-settings='{\"background_background\":\"gradient\"}'>\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-9a2cf17\" data-id=\"9a2cf17\" data-element_type=\"column\" data-e-type=\"column\" data-settings='{\"background_background\":\"classic\"}'>\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ac7a8d6 elementor-section-stretched elementor-hidden-mobile elementor-hidden-tablet elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ac7a8d6\" data-element_type=\"section\" data-e-type=\"section\" data-settings='{\"stretch_section\":\"section-stretched\"}'>\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-206c333 elementor-hidden-mobile\" data-id=\"206c333\" data-element_type=\"column\" data-e-type=\"column\" data-settings='{\"background_background\":\"classic\"}'>\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-75759df elementor-widget elementor-widget-heading\" data-id=\"75759df\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">FOR PHYSICIANS<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-19e3da9 elementor-nav-menu__align-end elementor-nav-menu--dropdown-tablet elementor-nav-menu__text-align-aside elementor-nav-menu--toggle elementor-nav-menu--burger elementor-widget elementor-widget-nav-menu\" data-id=\"19e3da9\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings='{\"layout\":\"vertical\",\"submenu_icon\":{\"value\":\"&lt;i class=\\\"\\\" aria-hidden=\\\"true\\\"&gt;&lt;\\\/i&gt;\",\"library\":\"\"},\"toggle\":\"burger\"}' data-widget_type=\"nav-menu.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<nav aria-label=\"Menu\" class=\"elementor-nav-menu--main elementor-nav-menu__container elementor-nav-menu--layout-vertical e--pointer-background e--animation-fade\">\n\t\t\t\t<ul id=\"menu-1-19e3da9\" class=\"elementor-nav-menu sm-vertical\"><li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5540\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/harmony-test-procedure\/\" class=\"elementor-item menu-link\">Harmony&reg; Test procedure<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5541\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/aspects-of-counseling\/\" class=\"elementor-item menu-link\">Aspects of counseling<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5542\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/\" class=\"elementor-item menu-link\">Limitations of the Harmony&reg; Test<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-29425\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/di-george-syndrome-en\/\" class=\"elementor-item menu-link\">Microdeletion 22q11.2<\/a><\/li>\n<li class=\"menu-item menu-item-type-taxonomy menu-item-object-tribe_events_cat menu-item-26479\"><a href=\"https:\/\/www.cenata.de\/en\/events\/category\/congresses\/\" class=\"elementor-item menu-link\">Congresses<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-23368\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/useful-links\/\" class=\"elementor-item menu-link\">Useful links<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-22963\"><a href=\"https:\/\/www.cenata.de\/en\/services\/download\/\" class=\"elementor-item menu-link\">Download<\/a><\/li>\n<\/ul>\t\t\t<\/nav>\n\t\t\t\t\t<div class=\"elementor-menu-toggle\" role=\"button\" tabindex=\"0\" aria-label=\"Menu Toggle\" aria-expanded=\"false\">\n\t\t\t<i aria-hidden=\"true\" role=\"presentation\" class=\"elementor-menu-toggle__icon--open eicon-menu-bar\"><\/i><i aria-hidden=\"true\" role=\"presentation\" class=\"elementor-menu-toggle__icon--close eicon-close\"><\/i>\t\t<\/div>\n\t\t\t\t\t<nav class=\"elementor-nav-menu--dropdown elementor-nav-menu__container\" aria-hidden=\"true\">\n\t\t\t\t<ul id=\"menu-2-19e3da9\" class=\"elementor-nav-menu sm-vertical\"><li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5540\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/harmony-test-procedure\/\" class=\"elementor-item menu-link\" tabindex=\"-1\">Harmony&reg; Test procedure<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5541\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/aspects-of-counseling\/\" class=\"elementor-item menu-link\" tabindex=\"-1\">Aspects of counseling<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5542\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/\" class=\"elementor-item menu-link\" tabindex=\"-1\">Limitations of the Harmony&reg; Test<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-29425\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/di-george-syndrome-en\/\" class=\"elementor-item menu-link\" tabindex=\"-1\">Microdeletion 22q11.2<\/a><\/li>\n<li class=\"menu-item menu-item-type-taxonomy menu-item-object-tribe_events_cat menu-item-26479\"><a href=\"https:\/\/www.cenata.de\/en\/events\/category\/congresses\/\" class=\"elementor-item menu-link\" tabindex=\"-1\">Congresses<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-23368\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/useful-links\/\" class=\"elementor-item menu-link\" tabindex=\"-1\">Useful links<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-22963\"><a href=\"https:\/\/www.cenata.de\/en\/services\/download\/\" class=\"elementor-item menu-link\" tabindex=\"-1\">Download<\/a><\/li>\n<\/ul>\t\t\t<\/nav>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2c1db88 elementor-widget elementor-widget-heading\" data-id=\"2c1db88\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">SEARCH<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e4f663a elementor-search-form--skin-classic elementor-search-form--button-type-icon elementor-search-form--icon-search elementor-widget elementor-widget-search-form\" data-id=\"e4f663a\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings='{\"skin\":\"classic\"}' data-widget_type=\"search-form.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<search role=\"search\">\n\t\t\t<form class=\"elementor-search-form\" action=\"https:\/\/www.cenata.de\/en\/\" method=\"get\">\n\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-search-form__container\">\n\t\t\t\t\t<label class=\"elementor-screen-only\" for=\"elementor-search-form-e4f663a\">Search<\/label>\n\n\t\t\t\t\t\n\t\t\t\t\t<input id=\"elementor-search-form-e4f663a\" placeholder=\"Suche...\" class=\"elementor-search-form__input\" type=\"search\" name=\"s\" value=\"\">\n\t\t\t\t\t<input type=\"hidden\" name=\"lang\" value=\"en\">\n\t\t\t\t\t\t\t\t\t\t\t<button class=\"elementor-search-form__submit\" type=\"submit\" aria-label=\"Search\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-search\"><\/i>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/button>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t<\/form>\n\t\t<\/search>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-cd5ffa0\" data-id=\"cd5ffa0\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e675ff9 elementor-widget elementor-widget-heading\" data-id=\"e675ff9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Limitations of the Harmony&reg; Test<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1cbc966 elementor-widget elementor-widget-text-editor\" data-id=\"1cbc966\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<header class=\"entry-content-header\"><header class=\"entry-content-header\"><p><a class=\"encyclopedia\" title=\"Non-invasive prenatal tests are molecular genetic analyses in prenatal diagnostics to detect fetal chromosomal anomalies from the maternal blood, avoiding the risk of miscarriage inherent in more invasive methods.\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/nipt\/\" target=\"_self\">NIPT<\/a>&nbsp;(non-invasive prenatal test) methods such as the Harmony<sup>&reg;<\/sup>&nbsp;Test are used to detect chromosomal disorders (trisomies 21, 18, 13, and X\/Y). What makes this method special is that it is non-invasive: only the mother&rsquo;s blood is tested.<\/p><p>A <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/nipt\/\" target=\"_self\" title=\"Non-invasive prenatal tests are molecular genetic analyses in prenatal diagnostics to detect fetal chromosomal anomalies from the maternal blood, avoiding the risk of miscarriage inherent in more invasive methods.\" class=\"encyclopedia\">NIPT<\/a> method, however, cannot replace an ultrasound scan in the first&nbsp;<a class=\"encyclopedia\" title=\"Trimester is the medical term used to describe the division of a pregnancy into three phases of three months each.\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trimester\/\" target=\"_self\">trimester<\/a>. First <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trimester\/\" target=\"_self\" title=\"Trimester is the medical term used to describe the division of a pregnancy into three phases of three months each.\" class=\"encyclopedia\">trimester<\/a> screening and\/or ultrasound scan towards the end of the first <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trimester\/\" target=\"_self\" title=\"Trimester is the medical term used to describe the division of a pregnancy into three phases of three months each.\" class=\"encyclopedia\">trimester<\/a> can detect possible disorders in the&nbsp;<a class=\"encyclopedia\" title=\"Relating to the unborn child\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\">fetal<\/a>&nbsp;organs and is still strongly recommended.<\/p><\/header><\/header>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f0af961 elementor-widget elementor-widget-toggle\" data-id=\"f0af961\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2521\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-2521\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Mosaicism, partial trisomies or translocations<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2521\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-2521\"><p><a class=\"encyclopedia\" title=\"cell free fetal DNA: during pregnancy, the mother's blood contains not only maternal DNA but also cell-free fetal DNA\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/cffdna\/\" target=\"_self\">cffDNA<\/a>-based <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/nipt\/\" target=\"_self\" title=\"Non-invasive prenatal tests are molecular genetic analyses in prenatal diagnostics to detect fetal chromosomal anomalies from the maternal blood, avoiding the risk of miscarriage inherent in more invasive methods.\" class=\"encyclopedia\">NIPT<\/a> methods are not yet able to detect <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/chromosomal-mosaic\/\" target=\"_self\" title=\"Simultaneous presence of more than one cell lineage in an individual, each of which may have differing genetic content in terms of the number and structure of their chromosomes.\" class=\"encyclopedia\">chromosomal mosaic<\/a>ism, partial trisomies or <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/translocation\/\" target=\"_self\" title=\"Translocation is the relocation of one chromosome section to a different position within a set of chromosomes.\" class=\"encyclopedia\">translocation<\/a>s.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2522\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-2522\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Proportion of cell-free fetal DNA<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2522\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-2522\"><p>In order to ensure the detection of a chromosomal disorder in the unborn child, the proportion of cell-free <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">fetal<\/a> <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/dna\/\" target=\"_self\" title=\"Deoxyribonucleic acid: biomolecule and carrier of genetic information\" class=\"encyclopedia\">DNA<\/a> (<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/cffdna\/\" target=\"_self\" title=\"cell free fetal DNA: during pregnancy, the mother's blood contains not only maternal DNA but also cell-free fetal DNA\" class=\"encyclopedia\">cffDNA<\/a>) (&ldquo;<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">Fetal<\/a> Fraction&rdquo;) in the mother&rsquo;s blood must be at least 4%&nbsp;<sup class=\"footnote\"><a id=\"fnref-615-1\" href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fn-615-1\">1<\/a><\/sup>. The Harmony<sup>&reg;<\/sup>&nbsp;Test can be performed after pregnancy week 10+0 because the proportion of <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">fetal<\/a> <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/dna\/\" target=\"_self\" title=\"Deoxyribonucleic acid: biomolecule and carrier of genetic information\" class=\"encyclopedia\">DNA<\/a> in the mother&rsquo;s blood rises with the length of the pregnancy (see figure below).<\/p><div id=\"attachment_606\" class=\"wp-caption aligncenter\"><a style=\"text-align: left; font-size: 1rem;\" href=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/SSW_cffDNA_EN.jpg\" target=\"_blank\" rel=\"noopener\"><img fetchpriority=\"high\" decoding=\"async\" class=\"wp-image-21970 size-full\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/SSW_cffDNA_EN.jpg\" alt=\"\" width=\"1432\" height=\"809\" srcset=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/SSW_cffDNA_EN.jpg 1432w, https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/SSW_cffDNA_EN-300x169.jpg 300w, https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/SSW_cffDNA_EN-1024x579.jpg 1024w, https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/SSW_cffDNA_EN-768x434.jpg 768w\" sizes=\"(max-width: 1432px) 100vw, 1432px\"><\/a><span style=\"color: var( --e-global-color-astglobalcolor1 ); text-align: left; font-size: 1rem;\"> Figure 1: Relationship of the &ldquo;<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">Fetal<\/a> Fraction&rdquo; and the week of pregnancy (<\/span><a class=\"encyclopedia\" style=\"text-align: left; font-size: 1rem;\" title='Schwangerschaftswoche (German for \"week of pregnancy\").' href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/ssw\/\" target=\"_self\">SSW<\/a><span style=\"color: var( --e-global-color-astglobalcolor1 ); text-align: left; font-size: 1rem;\">) <br>(modified acc. to&nbsp;<\/span><sup class=\"footnote\" style=\"color: var( --e-global-color-astglobalcolor1 ); text-align: left;\"><a id=\"fnref-615-2\" href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fn-615-2\">2<\/a><\/sup><span style=\"color: var( --e-global-color-astglobalcolor1 ); text-align: left; font-size: 1rem;\">)<\/span><\/div><p style=\"text-align: left;\">There is also a correlation between the mother&rsquo;s weight and the &ldquo;<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">Fetal<\/a> Fraction&rdquo;: the higher the mother&rsquo;s weight, the lower the proportion of <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">fetal<\/a> <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/dna\/\" target=\"_self\" title=\"Deoxyribonucleic acid: biomolecule and carrier of genetic information\" class=\"encyclopedia\">DNA<\/a> in the mother&rsquo;s blood.<\/p><div id=\"attachment_338\" class=\"wp-caption aligncenter\"><a href=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/Abhaengigkeit-der-Fetal-Fraction-vom-muetterlichen-Gewicht.jpg\"><img decoding=\"async\" class=\"aligncenter wp-image-259 size-full\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/Abhaengigkeit-der-Fetal-Fraction-vom-muetterlichen-Gewicht.jpg\" alt=\"\" width=\"1496\" height=\"930\" srcset=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/Abhaengigkeit-der-Fetal-Fraction-vom-muetterlichen-Gewicht.jpg 1496w, https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/Abhaengigkeit-der-Fetal-Fraction-vom-muetterlichen-Gewicht-300x186.jpg 300w, https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/Abhaengigkeit-der-Fetal-Fraction-vom-muetterlichen-Gewicht-1024x637.jpg 1024w, https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/Abhaengigkeit-der-Fetal-Fraction-vom-muetterlichen-Gewicht-768x477.jpg 768w\" sizes=\"(max-width: 1496px) 100vw, 1496px\"><\/a><\/div><div class=\"wp-caption aligncenter\" style=\"text-align: left;\">For every Harmony<sup>&reg;<\/sup>&nbsp;Test the &ldquo;<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">Fetal<\/a> Fraction&rdquo; is measured. If the <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">Fetal<\/a> Fraction is below 4%, the test cannot be evaluated. The sender will be informed that a new blood sample should be submitted at a slightly later date (approximately after 3 weeks). The patient will not be charged for tests that cannot be evaluated.<\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2523\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-2523\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Secret egg donation<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2523\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-2523\"><p>The Harmony<sup>&reg;<\/sup>&nbsp;Test can be performed irrespective of the manner of conception or origin of the ovum. Due to specialized bioinformatics analyses, however, by filling out the test requisition form it must be informed about an egg donation when the test is requested. If an egg donation is kept secret, the Harmony<sup>&reg;<\/sup>&nbsp;Test is not able to deliver a result.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2524\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-2524\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Vanishing twin<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2524\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-2524\"><p>In the case of a vanishing twin, we recommend performing the Harmony&reg; test no earlier than the 15th week of pregnancy, or at least eight weeks after the death of the second fetus<sup class=\"footnote\">10<\/sup>. This is because the placenta of the deceased twin often persists for several weeks, continuing to release cell-free <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/dna\/\" target=\"_self\" title=\"Deoxyribonucleic acid: biomolecule and carrier of genetic information\" class=\"encyclopedia\">DNA<\/a>.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2525\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-2525\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Transplant, malignancy or maternal aneuploidy<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2525\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-2525\"><p>The Harmony<sup>&reg;<\/sup>&nbsp;Test is not validated for use in pregnancies with maternal <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/aneuploidie\/\" target=\"_self\" title=\"An abnormal number of chromosomes in a cell; for example, there may be a copy of a chromosome missing, or extra, in a cell.\" class=\"encyclopedia\">aneuploidy<\/a>, transplant or malignancy.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2526\" class=\"elementor-tab-title\" data-tab=\"6\" role=\"button\" aria-controls=\"elementor-tab-content-2526\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">X\/Y analysis in twins<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2526\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"6\" role=\"region\" aria-labelledby=\"elementor-tab-title-2526\">The Harmony&reg; test can be used for twin pregnancies.\n\nA recent study by Judah et al. (2021) on twin analyses found that the detection and false-positive rates for <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy-21\/\" target=\"_self\" title=\"Trisomy 21 is the most common numerical chromosomal disorder in newborns. There are three copies of chromosome 21 and this leads to the development of Down syndrome.\" class=\"encyclopedia\">trisomy 21<\/a> are comparable to those of singleton pregnancies<sup>9<\/sup>. The publication shows that <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/cfdna\/\" target=\"_self\" title=\"cell free DNA: DNA fragments that naturally circulate freely in the bloodstream.\" class=\"encyclopedia\">cfDNA<\/a>-based screening for the three relevant trisomies in Gemini pregnancies consistently outperforms first <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trimester\/\" target=\"_self\" title=\"Trimester is the medical term used to describe the division of a pregnancy into three phases of three months each.\" class=\"encyclopedia\">trimester<\/a> screening.\n\nJudah et al.&rsquo;s meta-analysis was based on the Nicolaides group&rsquo;s studies with the Harmony&reg; test and publications with <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/mpss\/\" target=\"_self\" title=\"Massively parallel shotgun sequencing: the amplification and sequencing of maternal and fetal DNA; the proportion of chromosomes represented in a sample is compared to what is expected for those chromosomes.\" class=\"encyclopedia\">MPSS<\/a>* methods. The detection and false-positive rates for noninvasive prenatal testing (<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/nipt\/\" target=\"_self\" title=\"Non-invasive prenatal tests are molecular genetic analyses in prenatal diagnostics to detect fetal chromosomal anomalies from the maternal blood, avoiding the risk of miscarriage inherent in more invasive methods.\" class=\"encyclopedia\">NIPT<\/a>) in twin pregnancies are<sup>9<\/sup>:\n<table>\n<tbody>\n<tr>\n<td><a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy\/\" target=\"_self\" title=\"Trisomy means that there are three copies (trisom) of a complete or partial chromosome, instead of the normal two (disom).\" class=\"encyclopedia\">Trisomy<\/a><\/td>\n<td>Detection rate<\/td>\n<td>False positive rate<\/td>\n<td>Number of <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy\/\" target=\"_self\" title=\"Trisomy means that there are three copies (trisom) of a complete or partial chromosome, instead of the normal two (disom).\" class=\"encyclopedia\">trisomy<\/a> cases<\/td>\n<td>Number of euploid gemini pregnancies<\/td>\n<\/tr>\n<tr>\n<td>21<\/td>\n<td><center>99,0 %<\/center><\/td>\n<td><center>0,02 %<\/center><\/td>\n<td><center>137<\/center><\/td>\n<td><center>7507<\/center><\/td>\n<\/tr>\n<tr>\n<td>18<\/td>\n<td><center>92,8 %<\/center><\/td>\n<td><center>0,01 %<\/center><\/td>\n<td><center>50<\/center><\/td>\n<td><center>6840<\/center><\/td>\n<\/tr>\n<tr>\n<td>13<\/td>\n<td><center>94,7 %<\/center><\/td>\n<td><center>0.10 %<\/center><\/td>\n<td><center>11<\/center><\/td>\n<td><center>6290<\/center><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\nCurrently, it is not possible to make a statement about sex chromosomal disorders (X\/Y analysis), such as Turner or <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/klinefelter-syndrome\/\" target=\"_self\" title=\"This chromosomal disorder affects males and is characterised by an extra X-chromosome in all, or in a proportion, of the cells of the body. Further information about Klinefelter syndrome can be found here.\" class=\"encyclopedia\">Klinefelter syndrome<\/a>, for twins.\n\nThe table below shows which Harmony&reg; test variant is possible for which pregnancy.\n<table>\n<tbody>\n<tr>\n<td><\/td>\n<td>Singleton pregnancies<\/td>\n<td>Twin pregnancies<\/td>\n<td>More than two fetuses<\/td>\n\n<\/tr>\n<tr>\n<td>Harmony<sup>&reg;<\/sup> T21\/T18\/T13<\/td>\n<td><center><img decoding=\"async\" class=\"alignnone wp-image-1356 size-full\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/haken.png\" alt=\"Ja-2\" width=\"25\" height=\"27\"><\/center><\/td>\n<td><center><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-1356 size-full\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/haken.png\" alt=\"Ja-6\" width=\"25\" height=\"27\"><\/center><\/td>\n<td><center><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-1359 size-full\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/h_kreuz.png\" alt=\"Nein-3\" width=\"19\" height=\"19\"><\/center><\/td>\n\n<\/tr>\n<tr>\n<td>Harmony<sup>&reg;<\/sup> T21\/18\/13 + X\/Y-Analysis<\/td>\n<td><center><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-1356 size-full\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/haken.png\" alt=\"Ja-3\" width=\"25\" height=\"27\"><\/center><\/td>\n<td><center><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-1359 size-full\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/h_kreuz.png\" alt=\"Nein-1\" width=\"19\" height=\"19\"><\/center><\/td>\n<td><center><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-1359 size-full\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/h_kreuz.png\" alt=\"Nein-4\" width=\"19\" height=\"19\"><\/center><\/td>\n\n<\/tr>\n<tr>\n<td>Sex determination<\/td>\n<td><center><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-1356 size-full\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/haken.png\" alt=\"Ja-4\" width=\"25\" height=\"27\"><\/center><\/td>\n<td><center><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-1356 size-full\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/haken.png\" alt=\"Ja-7\" width=\"25\" height=\"27\"><\/center><\/td>\n<td><center><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-1359 size-full\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/h_kreuz.png\" alt=\"Nein-5\" width=\"19\" height=\"19\"><\/center><\/td>\n\n<\/tr>\n<\/tbody>\n<\/table>\nSex determination is possible for both singleton and twin pregnancies. In accordance with the Genetic Diagnostics Act, the <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">fetal<\/a> sex is communicated from week 14+0 (p.m.) onwards.<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2527\" class=\"elementor-tab-title\" data-tab=\"7\" role=\"button\" aria-controls=\"elementor-tab-content-2527\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Limitations of the Harmony&reg;&nbsp;Test<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2527\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"7\" role=\"region\" aria-labelledby=\"elementor-tab-title-2527\"><p>In a very small number of cases, the Harmony<sup>&reg;<\/sup>&nbsp;Test cannot be performed successfully<sup class=\"footnote\"><a id=\"fnref-615-5\" href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fn-615-5\">5<\/a><\/sup>&nbsp;<sup class=\"footnote\"><a id=\"fnref-615-6\" href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fn-615-6\">6<\/a><\/sup>. This is usually because the proportion of cell-free <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">fetal<\/a> <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/dna\/\" target=\"_self\" title=\"Deoxyribonucleic acid: biomolecule and carrier of genetic information\" class=\"encyclopedia\">DNA<\/a> (<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/cffdna\/\" target=\"_self\" title=\"cell free fetal DNA: during pregnancy, the mother's blood contains not only maternal DNA but also cell-free fetal DNA\" class=\"encyclopedia\">cffDNA<\/a>) in the blood is too low for a result to be obtained. In such a case we recommend blood be taken again at a later point (after 2 weeks) and the Harmony<sup>&reg;<\/sup>&nbsp;Test be repeated. In our experience, 50% of the second submissions can then be succesfully evaluated. In case a test result cannot be obtained, a decision has to be made with the patient as to whether further first <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trimester\/\" target=\"_self\" title=\"Trimester is the medical term used to describe the division of a pregnancy into three phases of three months each.\" class=\"encyclopedia\">trimester<\/a> screening or possibly an invasive procedure should be performed.<\/p><p>Other reasons for test failure include the existence of an egg donation about which was not informed. With the subsequent information of an egg donation, the Harmony<sup>&reg;<\/sup>&nbsp;Test can usually obtain a result.<\/p><p>Transplantations or previously unknown (and in general benign) maternal chromosomal disorders can also lead to a failure of the test. For these cases the Harmony<sup>&reg;<\/sup>&nbsp;Test is not validated and should not be performed or repeated.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2528\" class=\"elementor-tab-title\" data-tab=\"8\" role=\"button\" aria-controls=\"elementor-tab-content-2528\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Confirmation of the positive result through an invasive diagnostic method<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2528\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"8\" role=\"region\" aria-labelledby=\"elementor-tab-title-2528\"><p>Despite significant improvements over former non-invasive tests, the detection rate for the Harmony<sup>&reg;<\/sup>&nbsp;Prenatal Test is not 100%. False-positive results may occure.&nbsp;Therefore the Harmony<sup>&reg;<\/sup>&nbsp;Prenatal Test should be regarded as a screening test and not a diagnostic test. A positive (abnormal) result should therefore always be confirmed by a second, diagnostic method (<a class=\"encyclopedia\" title=\"Invasive collection of placental cells through the cervix or abdominal wall to detect chromosomal diseases for prenatal diagnostics.\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/chorionic-villus-sampling\/\" target=\"_self\">chorionic villus sampling<\/a>&nbsp;or&nbsp;<a class=\"encyclopedia\" title=\"see amniocentesis\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/amniotic-puncture\/\" target=\"_self\">amniotic puncture<\/a>) with a subsequent&nbsp;<a class=\"encyclopedia\" title=\"A chromosome is an complex of tightly-coiled DNA and the proteins which hold the structure together. Normal human cells contain 23 pairs of chromosomes - 22 autosomes and the X and Y sex chromosomes.\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/chromosome\/\" target=\"_self\">chromosome<\/a>&nbsp;analysis.<\/p><p>False-negative results are also possible. This is more common for&nbsp;<a class=\"encyclopedia\" title=\"Trisomy 13 occurs when there are three copies of chromosome 13. This leads to the development of Patau syndrome.\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy-13\/\" target=\"_self\">trisomy 13<\/a>.<\/p><p>The Harmony<sup>&reg;<\/sup>&nbsp;Test detects around 30 out of 32 <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy-13\/\" target=\"_self\" title=\"Trisomy 13 occurs when there are three copies of chromosome 13. This leads to the development of Patau syndrome.\" class=\"encyclopedia\">trisomy 13<\/a> cases in its current version.&nbsp;<span class=\"tlid-translation translation\"><span class=\"\" title=\"\">A summary of all previous studies on <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy-13\/\" target=\"_self\" title=\"Trisomy 13 occurs when there are three copies of chromosome 13. This leads to the development of Patau syndrome.\" class=\"encyclopedia\">trisomy 13<\/a> revealed an average detection rate of<\/span><\/span>&nbsp;93,8%&nbsp;<sup class=\"footnote\"><a id=\"fnref-615-7\" href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fn-615-7\">7<\/a><\/sup>. <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy-13\/\" target=\"_self\" title=\"Trisomy 13 occurs when there are three copies of chromosome 13. This leads to the development of Patau syndrome.\" class=\"encyclopedia\">Trisomy 13<\/a> is, however, relatively easy to detect in an ultrasound scan during first <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trimester\/\" target=\"_self\" title=\"Trimester is the medical term used to describe the division of a pregnancy into three phases of three months each.\" class=\"encyclopedia\">trimester<\/a> screening.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0c3453c elementor-widget elementor-widget-text-editor\" data-id=\"0c3453c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ol><li><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22572044\" target=\"_blank\" rel=\"noopener\">Ashoor G, Poon L, Syngelaki A, Mosimann B, Nicolaides KH. Fetal Fraction in Maternal Plasma Cell-Free DNA at 11&ndash;13 Weeks&rsquo; Gestation: Effect of Maternal and Fetal Factors. Fetal Diagn Ther 2012;31:237-243.<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-1\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-2\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/23553731\" target=\"_blank\" rel=\"noopener\">Wang E, Batey A, Struble C, Musci T, Song K, Oliphant A. Gestational age and maternal weight effects on fetal cell-free DNA in maternal plasma. Prenat Diagn. 2013 Jul;33(7):662-6. doi: 10.1002\/pd.4119. Epub 2013 May 9.<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-2\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-3\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/25297464\" target=\"_blank\" rel=\"noopener\">Bevilacqua E, Gil MM, Nicolaides KH, Ordo&ntilde;ez E, Cirigliano V, Dierickx H, Willems PJ, Jani JC. Performance of screening for aneuploidies by cell-free DNA analysis of maternal blood in twin pregnancies. Ultrasound Obstet Gynecol. 2015 Jan;45(1):61-6. doi: 10.1002\/uog.14690. Epub 2014 Dec 4.<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-3\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-4\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/24247435\" target=\"_blank\" rel=\"noopener\">Gil MM, Quezada MS, Bregant B, Syngelaki A, Nicolaides KH. Cell-free DNA analysis for trisomy risk assessment in first-trimester twin pregnancies. Fetal Diagn Ther. 2014;35(3):204-11. doi: 10.1159\/000356495. Epub 2013 Nov 15.<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-4\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-5\"><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/32804406\/\" target=\"_blank\" rel=\"noopener\">L&uuml;thgens K, Grati FR, Sinzel M, H&auml;big K, Kagan KO. Confirmation rate of cell free DNA screening for sex chromosomal abnormalities according to the method of confirmatory testing. Prenat Diagn. 2020 Aug 17. doi: 10.1002\/pd.5814. Epub ahead of print. PMID: 32804406.<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-5\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-6\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=10.1002%2Fuog.18905\" target=\"_blank\" rel=\"noopener\">Kagan, K. O., Sroka, F., Sonek, J., Abele, H., L&uuml;thgens, K., Schmid, M., Wagner, P., Brucker, S., Wallwiener, D. and Hoopmann, M. (), First trimester screening based on ultrasound and cfDNA vs. first-trimester combined screening &ndash; a randomized controlled study. Ultrasound Obstet Gynecol. Accepted Author Manuscript. doi:10.1002\/uog.18905<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-6\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-7\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/26332378\" target=\"_blank\" rel=\"noopener\">Stokowski R, Wang E, White K, Batey A, Jacobsson B, Brar H, Balanarasimha M, Hollemon D, Sparks A, Nicolaides K, Musci TJ.: Clinical performance of non-invasive prenatal testing (NIPT) using targeted cell-free DNA analysis in maternal plasma with microarrays or next generation sequencing (NGS) is consistent across multiple controlled clinical studies. Prenat Diagn. 2015 Sep 1<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-7\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-8\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=Schmid+M+et+al.+Fetal+Diagn+Ther.+2017\" target=\"_blank\" rel=\"noopener\">Schmid M et al. Prenatal Screening for 22q11.2 Deletion Using a Targeted Microarray-Based Cell-Free DNA Test.Fetal Diagn Ther. 2017 Nov 8, E-pub ahead of print<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-8\">&#8617;<\/a><\/span><\/li><li>Judah H. et al.: Cell-free <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/dna\/\" target=\"_self\" title=\"Deoxyribonucleic acid: biomolecule and carrier of genetic information\" class=\"encyclopedia\">DNA<\/a> testing of maternal blood in screening for trisomies in twin pregnancy: updated cohort study at 10&ndash;14 weeks and metaanalysis. Ultrasound Obstet Gynecol 2021; 58: 178&ndash;189<span style=\"font-size: 16px;\">&nbsp;<\/span><span class=\"footnotereverse\" style=\"font-size: 16px;\"><a href=\"https:\/\/www.cenata.de\/fuer-aerzte\/einschraenkungen-des-harmony-tests\/#fnref-251-3\">&#8617;<\/a><\/span><\/li><li>van Eekhout JCA, Bax CJ, Schuurman LVP, Becking EC, van der Ven AJEM, Van Opstal D, Boon EMJ, Macville MVE, Bekker MN, Galjaard RJH; Dutch <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/nipt\/\" target=\"_self\" title=\"Non-invasive prenatal tests are molecular genetic analyses in prenatal diagnostics to detect fetal chromosomal anomalies from the maternal blood, avoiding the risk of miscarriage inherent in more invasive methods.\" class=\"encyclopedia\">NIPT<\/a> Consortium. Performance of non-invasive prenatal testing in vanishing-twin and multiple pregnancies: results of TRIDENT-2 study. Ultrasound Obstet Gynecol. 2025 Sep 6. doi: 10.1002\/uog.70015. Epub ahead of print. PMID: 40913805.<\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b733ede elementor-hidden-mobile elementor-hidden-desktop elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b733ede\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-941f9b7 elementor-hidden-mobile\" data-id=\"941f9b7\" data-element_type=\"column\" data-e-type=\"column\" data-settings='{\"background_background\":\"classic\"}'>\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c33687d elementor-widget elementor-widget-heading\" data-id=\"c33687d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">FOR PHYSICIANS<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ecbe957 elementor-nav-menu__align-end elementor-nav-menu--dropdown-mobile elementor-nav-menu__text-align-aside elementor-nav-menu--toggle elementor-nav-menu--burger elementor-widget elementor-widget-nav-menu\" data-id=\"ecbe957\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings='{\"layout\":\"vertical\",\"submenu_icon\":{\"value\":\"&lt;i class=\\\"\\\" aria-hidden=\\\"true\\\"&gt;&lt;\\\/i&gt;\",\"library\":\"\"},\"toggle\":\"burger\"}' data-widget_type=\"nav-menu.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<nav aria-label=\"Menu\" class=\"elementor-nav-menu--main elementor-nav-menu__container elementor-nav-menu--layout-vertical e--pointer-background e--animation-fade\">\n\t\t\t\t<ul id=\"menu-1-ecbe957\" class=\"elementor-nav-menu sm-vertical\"><li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5540\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/harmony-test-procedure\/\" class=\"elementor-item menu-link\">Harmony&reg; Test procedure<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5541\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/aspects-of-counseling\/\" class=\"elementor-item menu-link\">Aspects of counseling<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5542\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/\" class=\"elementor-item menu-link\">Limitations of the Harmony&reg; Test<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-29425\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/di-george-syndrome-en\/\" class=\"elementor-item menu-link\">Microdeletion 22q11.2<\/a><\/li>\n<li class=\"menu-item menu-item-type-taxonomy menu-item-object-tribe_events_cat menu-item-26479\"><a href=\"https:\/\/www.cenata.de\/en\/events\/category\/congresses\/\" class=\"elementor-item menu-link\">Congresses<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-23368\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/useful-links\/\" class=\"elementor-item menu-link\">Useful links<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-22963\"><a href=\"https:\/\/www.cenata.de\/en\/services\/download\/\" class=\"elementor-item menu-link\">Download<\/a><\/li>\n<\/ul>\t\t\t<\/nav>\n\t\t\t\t\t<div class=\"elementor-menu-toggle\" role=\"button\" tabindex=\"0\" aria-label=\"Menu Toggle\" aria-expanded=\"false\">\n\t\t\t<i aria-hidden=\"true\" role=\"presentation\" class=\"elementor-menu-toggle__icon--open eicon-menu-bar\"><\/i><i aria-hidden=\"true\" role=\"presentation\" class=\"elementor-menu-toggle__icon--close eicon-close\"><\/i>\t\t<\/div>\n\t\t\t\t\t<nav class=\"elementor-nav-menu--dropdown elementor-nav-menu__container\" aria-hidden=\"true\">\n\t\t\t\t<ul id=\"menu-2-ecbe957\" class=\"elementor-nav-menu sm-vertical\"><li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5540\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/harmony-test-procedure\/\" class=\"elementor-item menu-link\" tabindex=\"-1\">Harmony&reg; Test procedure<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5541\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/aspects-of-counseling\/\" class=\"elementor-item menu-link\" tabindex=\"-1\">Aspects of counseling<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5542\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/\" class=\"elementor-item menu-link\" tabindex=\"-1\">Limitations of the Harmony&reg; Test<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-29425\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/di-george-syndrome-en\/\" class=\"elementor-item menu-link\" tabindex=\"-1\">Microdeletion 22q11.2<\/a><\/li>\n<li class=\"menu-item menu-item-type-taxonomy menu-item-object-tribe_events_cat menu-item-26479\"><a href=\"https:\/\/www.cenata.de\/en\/events\/category\/congresses\/\" class=\"elementor-item menu-link\" tabindex=\"-1\">Congresses<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-23368\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/useful-links\/\" class=\"elementor-item menu-link\" tabindex=\"-1\">Useful links<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-22963\"><a href=\"https:\/\/www.cenata.de\/en\/services\/download\/\" class=\"elementor-item menu-link\" tabindex=\"-1\">Download<\/a><\/li>\n<\/ul>\t\t\t<\/nav>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a512111 elementor-widget elementor-widget-heading\" data-id=\"a512111\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">SEARCH<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a963f3c elementor-search-form--skin-classic elementor-search-form--button-type-icon elementor-search-form--icon-search elementor-widget elementor-widget-search-form\" data-id=\"a963f3c\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings='{\"skin\":\"classic\"}' data-widget_type=\"search-form.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<search role=\"search\">\n\t\t\t<form class=\"elementor-search-form\" action=\"https:\/\/www.cenata.de\/en\/\" method=\"get\">\n\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-search-form__container\">\n\t\t\t\t\t<label class=\"elementor-screen-only\" for=\"elementor-search-form-a963f3c\">Search<\/label>\n\n\t\t\t\t\t\n\t\t\t\t\t<input id=\"elementor-search-form-a963f3c\" placeholder=\"Suche...\" class=\"elementor-search-form__input\" type=\"search\" name=\"s\" value=\"\">\n\t\t\t\t\t<input type=\"hidden\" name=\"lang\" value=\"en\">\n\t\t\t\t\t\t\t\t\t\t\t<button class=\"elementor-search-form__submit\" type=\"submit\" aria-label=\"Search\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-search\"><\/i>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/button>\n\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t<\/form>\n\t\t<\/search>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-a789c81\" data-id=\"a789c81\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b304add elementor-widget elementor-widget-heading\" data-id=\"b304add\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Limitations of the Harmony&reg; Test<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4c1956b elementor-widget elementor-widget-text-editor\" data-id=\"4c1956b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<header class=\"entry-content-header\"><header class=\"entry-content-header\"><p><a class=\"encyclopedia\" title=\"Non-invasive prenatal tests are molecular genetic analyses in prenatal diagnostics to detect fetal chromosomal anomalies from the maternal blood, avoiding the risk of miscarriage inherent in more invasive methods.\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/nipt\/\" target=\"_self\">NIPT<\/a>&nbsp;(non-invasive prenatal test) methods such as the Harmony<sup>&reg;<\/sup>&nbsp;Test are used to detect chromosomal disorders (trisomies 21, 18, 13, and X\/Y). What makes this method special is that it is non-invasive: only the mother&rsquo;s blood is tested.<\/p><p>A <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/nipt\/\" target=\"_self\" title=\"Non-invasive prenatal tests are molecular genetic analyses in prenatal diagnostics to detect fetal chromosomal anomalies from the maternal blood, avoiding the risk of miscarriage inherent in more invasive methods.\" class=\"encyclopedia\">NIPT<\/a> method, however, cannot replace an ultrasound scan in the first&nbsp;<a class=\"encyclopedia\" title=\"Trimester is the medical term used to describe the division of a pregnancy into three phases of three months each.\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trimester\/\" target=\"_self\">trimester<\/a>. First <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trimester\/\" target=\"_self\" title=\"Trimester is the medical term used to describe the division of a pregnancy into three phases of three months each.\" class=\"encyclopedia\">trimester<\/a> screening and\/or ultrasound scan towards the end of the first <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trimester\/\" target=\"_self\" title=\"Trimester is the medical term used to describe the division of a pregnancy into three phases of three months each.\" class=\"encyclopedia\">trimester<\/a> can detect possible disorders in the&nbsp;<a class=\"encyclopedia\" title=\"Relating to the unborn child\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\">fetal<\/a>&nbsp;organs and is still strongly recommended.<\/p><\/header><\/header>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-13a4e45 elementor-widget elementor-widget-toggle\" data-id=\"13a4e45\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2051\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-2051\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Mosaicism, partial trisomies or translocations<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2051\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-2051\"><p><a class=\"encyclopedia\" title=\"cell free fetal DNA: during pregnancy, the mother's blood contains not only maternal DNA but also cell-free fetal DNA\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/cffdna\/\" target=\"_self\">cffDNA<\/a>-based <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/nipt\/\" target=\"_self\" title=\"Non-invasive prenatal tests are molecular genetic analyses in prenatal diagnostics to detect fetal chromosomal anomalies from the maternal blood, avoiding the risk of miscarriage inherent in more invasive methods.\" class=\"encyclopedia\">NIPT<\/a> methods are not yet able to detect <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/chromosomal-mosaic\/\" target=\"_self\" title=\"Simultaneous presence of more than one cell lineage in an individual, each of which may have differing genetic content in terms of the number and structure of their chromosomes.\" class=\"encyclopedia\">chromosomal mosaic<\/a>ism, partial trisomies or <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/translocation\/\" target=\"_self\" title=\"Translocation is the relocation of one chromosome section to a different position within a set of chromosomes.\" class=\"encyclopedia\">translocation<\/a>s.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2052\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-2052\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Proportion of cell-free fetal DNA<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2052\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-2052\"><p>In order to ensure the detection of a chromosomal disorder in the unborn child, the proportion of cell-free <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">fetal<\/a> <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/dna\/\" target=\"_self\" title=\"Deoxyribonucleic acid: biomolecule and carrier of genetic information\" class=\"encyclopedia\">DNA<\/a> (<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/cffdna\/\" target=\"_self\" title=\"cell free fetal DNA: during pregnancy, the mother's blood contains not only maternal DNA but also cell-free fetal DNA\" class=\"encyclopedia\">cffDNA<\/a>) (&ldquo;<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">Fetal<\/a> Fraction&rdquo;) in the mother&rsquo;s blood must be at least 4%&nbsp;<sup class=\"footnote\"><a id=\"fnref-615-1\" href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fn-615-1\">1<\/a><\/sup>. The Harmony<sup>&reg;<\/sup>&nbsp;Test can be performed after pregnancy week 10+0 because the proportion of <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">fetal<\/a> <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/dna\/\" target=\"_self\" title=\"Deoxyribonucleic acid: biomolecule and carrier of genetic information\" class=\"encyclopedia\">DNA<\/a> in the mother&rsquo;s blood rises with the length of the pregnancy (see figure below).<\/p><div id=\"attachment_606\" class=\"wp-caption aligncenter\"><a style=\"text-align: left; font-size: 1rem;\" href=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/SSW_cffDNA_EN.jpg\" target=\"_blank\" rel=\"noopener\"><img fetchpriority=\"high\" decoding=\"async\" class=\"wp-image-21970 size-full\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/SSW_cffDNA_EN.jpg\" alt=\"\" width=\"1432\" height=\"809\" srcset=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/SSW_cffDNA_EN.jpg 1432w, https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/SSW_cffDNA_EN-300x169.jpg 300w, https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/SSW_cffDNA_EN-1024x579.jpg 1024w, https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/SSW_cffDNA_EN-768x434.jpg 768w\" sizes=\"(max-width: 1432px) 100vw, 1432px\"><\/a><span style=\"color: var( --e-global-color-astglobalcolor1 ); text-align: left; font-size: 1rem;\"> Figure 1: Relationship of the &ldquo;<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">Fetal<\/a> Fraction&rdquo; and the week of pregnancy (<\/span><a class=\"encyclopedia\" style=\"text-align: left; font-size: 1rem;\" title='Schwangerschaftswoche (German for \"week of pregnancy\").' href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/ssw\/\" target=\"_self\">SSW<\/a><span style=\"color: var( --e-global-color-astglobalcolor1 ); text-align: left; font-size: 1rem;\">) <br>(modified acc. to&nbsp;<\/span><sup class=\"footnote\" style=\"color: var( --e-global-color-astglobalcolor1 ); text-align: left;\"><a id=\"fnref-615-2\" href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fn-615-2\">2<\/a><\/sup><span style=\"color: var( --e-global-color-astglobalcolor1 ); text-align: left; font-size: 1rem;\">)<\/span><\/div><p style=\"text-align: left;\">There is also a correlation between the mother&rsquo;s weight and the &ldquo;<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">Fetal<\/a> Fraction&rdquo;: the higher the mother&rsquo;s weight, the lower the proportion of <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">fetal<\/a> <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/dna\/\" target=\"_self\" title=\"Deoxyribonucleic acid: biomolecule and carrier of genetic information\" class=\"encyclopedia\">DNA<\/a> in the mother&rsquo;s blood.<\/p><div id=\"attachment_338\" class=\"wp-caption aligncenter\"><a href=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/Abhaengigkeit-der-Fetal-Fraction-vom-muetterlichen-Gewicht.jpg\"><img decoding=\"async\" class=\"aligncenter wp-image-259 size-full\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/Abhaengigkeit-der-Fetal-Fraction-vom-muetterlichen-Gewicht.jpg\" alt=\"\" width=\"1496\" height=\"930\" srcset=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/Abhaengigkeit-der-Fetal-Fraction-vom-muetterlichen-Gewicht.jpg 1496w, https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/Abhaengigkeit-der-Fetal-Fraction-vom-muetterlichen-Gewicht-300x186.jpg 300w, https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/Abhaengigkeit-der-Fetal-Fraction-vom-muetterlichen-Gewicht-1024x637.jpg 1024w, https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/Abhaengigkeit-der-Fetal-Fraction-vom-muetterlichen-Gewicht-768x477.jpg 768w\" sizes=\"(max-width: 1496px) 100vw, 1496px\"><\/a><\/div><div class=\"wp-caption aligncenter\" style=\"text-align: left;\">For every Harmony<sup>&reg;<\/sup>&nbsp;Test the &ldquo;<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">Fetal<\/a> Fraction&rdquo; is measured. If the <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">Fetal<\/a> Fraction is below 4%, the test cannot be evaluated. The sender will be informed that a new blood sample should be submitted at a slightly later date (approximately after 3 weeks). The patient will not be charged for tests that cannot be evaluated.<\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2053\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-2053\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Secret egg donation<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2053\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-2053\"><p>The Harmony<sup>&reg;<\/sup>&nbsp;Test can be performed irrespective of the manner of conception or origin of the ovum. Due to specialized bioinformatics analyses, however, by filling out the test requisition form it must be informed about an egg donation when the test is requested. If an egg donation is kept secret, the Harmony<sup>&reg;<\/sup>&nbsp;Test is not able to deliver a result.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2054\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-2054\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Vanishing twin<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2054\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-2054\"><p>In the case of a vanishing twin, we recommend performing the Harmony&reg; test no earlier than the 15th week of pregnancy, or at least eight weeks after the death of the second fetus<sup class=\"footnote\">9<\/sup>. This is because the placenta of the deceased twin often persists for several weeks, continuing to release cell-free <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/dna\/\" target=\"_self\" title=\"Deoxyribonucleic acid: biomolecule and carrier of genetic information\" class=\"encyclopedia\">DNA<\/a>.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2055\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-2055\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Transplant, malignancy or maternal aneuploidy<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2055\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-2055\"><p>The Harmony<sup>&reg;<\/sup>&nbsp;Test is not validated for use in pregnancies with maternal <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/aneuploidie\/\" target=\"_self\" title=\"An abnormal number of chromosomes in a cell; for example, there may be a copy of a chromosome missing, or extra, in a cell.\" class=\"encyclopedia\">aneuploidy<\/a>, transplant or malignancy.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2056\" class=\"elementor-tab-title\" data-tab=\"6\" role=\"button\" aria-controls=\"elementor-tab-content-2056\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">X\/Y analysis in twins<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2056\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"6\" role=\"region\" aria-labelledby=\"elementor-tab-title-2056\"><p>The Harmony&reg; test can be used for twin pregnancies.<\/p><p>A recent study by Judah et al. (2021) on twin analyses found that the detection and false-positive rates for <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy-21\/\" target=\"_self\" title=\"Trisomy 21 is the most common numerical chromosomal disorder in newborns. There are three copies of chromosome 21 and this leads to the development of Down syndrome.\" class=\"encyclopedia\">trisomy 21<\/a> are comparable to those of singleton pregnancies<sup>9<\/sup>. The publication shows that <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/cfdna\/\" target=\"_self\" title=\"cell free DNA: DNA fragments that naturally circulate freely in the bloodstream.\" class=\"encyclopedia\">cfDNA<\/a>-based screening for the three relevant trisomies in Gemini pregnancies consistently outperforms first <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trimester\/\" target=\"_self\" title=\"Trimester is the medical term used to describe the division of a pregnancy into three phases of three months each.\" class=\"encyclopedia\">trimester<\/a> screening.<\/p><p>Judah et al.&rsquo;s meta-analysis was based on the Nicolaides group&rsquo;s studies with the Harmony&reg; test and publications with <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/mpss\/\" target=\"_self\" title=\"Massively parallel shotgun sequencing: the amplification and sequencing of maternal and fetal DNA; the proportion of chromosomes represented in a sample is compared to what is expected for those chromosomes.\" class=\"encyclopedia\">MPSS<\/a>* methods. The detection and false-positive rates for noninvasive prenatal testing (<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/nipt\/\" target=\"_self\" title=\"Non-invasive prenatal tests are molecular genetic analyses in prenatal diagnostics to detect fetal chromosomal anomalies from the maternal blood, avoiding the risk of miscarriage inherent in more invasive methods.\" class=\"encyclopedia\">NIPT<\/a>) in twin pregnancies are<sup>9<\/sup>:<\/p><table><tbody><tr><td><a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy\/\" target=\"_self\" title=\"Trisomy means that there are three copies (trisom) of a complete or partial chromosome, instead of the normal two (disom).\" class=\"encyclopedia\">Trisomy<\/a><\/td><td>Detection rate<\/td><td>False positive rate<\/td><td>Number of <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy\/\" target=\"_self\" title=\"Trisomy means that there are three copies (trisom) of a complete or partial chromosome, instead of the normal two (disom).\" class=\"encyclopedia\">trisomy<\/a> cases<\/td><td>Number of euploid gemini pregnancies<\/td><\/tr><tr><td>21<\/td><td><center>99,0 %<\/center><\/td><td><center>0,02 %<\/center><\/td><td><center>137<\/center><\/td><td><center>7507<\/center><\/td><\/tr><tr><td>18<\/td><td><center>92,8 %<\/center><\/td><td><center>0,01 %<\/center><\/td><td><center>50<\/center><\/td><td><center>6840<\/center><\/td><\/tr><tr><td>13<\/td><td><center>94,7 %<\/center><\/td><td><center>0.10 %<\/center><\/td><td><center>11<\/center><\/td><td><center>6290<\/center><\/td><\/tr><\/tbody><\/table><p>Currently, it is not possible to make a statement about sex chromosomal disorders (X\/Y analysis), such as Turner or <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/klinefelter-syndrome\/\" target=\"_self\" title=\"This chromosomal disorder affects males and is characterised by an extra X-chromosome in all, or in a proportion, of the cells of the body. Further information about Klinefelter syndrome can be found here.\" class=\"encyclopedia\">Klinefelter syndrome<\/a>, for twins.<\/p><p>The table below shows which Harmony&reg; test variant is possible for which pregnancy.<br>\n<\/p><table id=\"tablepress-4\" class=\"tablepress tablepress-id-4\">\n<tbody>\n<tr class=\"row-1\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\">Singleton pregnancies<\/td><td class=\"column-3\">Twin pregnancies<\/td><td class=\"column-4\">More than two fetuses<\/td>\n<\/tr>\n<tr class=\"row-2\">\n\t<td class=\"column-1\">Harmony&reg; T21\/T18\/T13<\/td><td class=\"column-2\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/haken.png\" alt=\"Haken\" width=\"25\" height=\"27\" class=\"alignnone size-full wp-image-1356\"><\/td><td class=\"column-3\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/haken.png\" alt=\"Haken\" width=\"25\" height=\"27\" class=\"alignnone size-full wp-image-1356\"><\/td><td class=\"column-4\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/h_kreuz.png\" alt=\"h_kreuz\" width=\"19\" height=\"19\" class=\"alignnone size-full wp-image-1359\"><\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">Harmony&reg; T21\/18\/13 + X\/Y-Analysis<\/td><td class=\"column-2\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/haken.png\" alt=\"Haken\" width=\"25\" height=\"27\" class=\"alignnone size-full wp-image-1356\"><\/td><td class=\"column-3\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/h_kreuz.png\" alt=\"h_kreuz\" width=\"19\" height=\"19\" class=\"alignnone size-full wp-image-1359\"><\/td><td class=\"column-4\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/h_kreuz.png\" alt=\"h_kreuz\" width=\"19\" height=\"19\" class=\"alignnone size-full wp-image-1359\"><\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\">sex determination<\/td><td class=\"column-2\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/haken.png\" alt=\"Haken\" width=\"25\" height=\"27\" class=\"alignnone size-full wp-image-1356\"><\/td><td class=\"column-3\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/haken.png\" alt=\"Haken\" width=\"25\" height=\"27\" class=\"alignnone size-full wp-image-1356\"><\/td><td class=\"column-4\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/h_kreuz.png\" alt=\"h_kreuz\" width=\"19\" height=\"19\" class=\"alignnone size-full wp-image-1359\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Sex determination is possible for both singleton and twin pregnancies. In accordance with the Genetic Diagnostics Act, the <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">fetal<\/a> sex is communicated from week 14+0 (p.m.) onwards.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2057\" class=\"elementor-tab-title\" data-tab=\"7\" role=\"button\" aria-controls=\"elementor-tab-content-2057\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Limitations of the Harmony&reg;&nbsp;Test<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2057\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"7\" role=\"region\" aria-labelledby=\"elementor-tab-title-2057\"><p>In a very small number of cases, the Harmony<sup>&reg;<\/sup>&nbsp;Test cannot be performed successfully<sup class=\"footnote\"><a id=\"fnref-615-5\" href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fn-615-5\">5<\/a><\/sup>&nbsp;<sup class=\"footnote\"><a id=\"fnref-615-6\" href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fn-615-6\">6<\/a><\/sup>. This is usually because the proportion of cell-free <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">fetal<\/a> <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/dna\/\" target=\"_self\" title=\"Deoxyribonucleic acid: biomolecule and carrier of genetic information\" class=\"encyclopedia\">DNA<\/a> (<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/cffdna\/\" target=\"_self\" title=\"cell free fetal DNA: during pregnancy, the mother's blood contains not only maternal DNA but also cell-free fetal DNA\" class=\"encyclopedia\">cffDNA<\/a>) in the blood is too low for a result to be obtained. In such a case we recommend blood be taken again at a later point (after 2 weeks) and the Harmony<sup>&reg;<\/sup>&nbsp;Test be repeated. In our experience, 50% of the second submissions can then be succesfully evaluated. In case a test result cannot be obtained, a decision has to be made with the patient as to whether further first <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trimester\/\" target=\"_self\" title=\"Trimester is the medical term used to describe the division of a pregnancy into three phases of three months each.\" class=\"encyclopedia\">trimester<\/a> screening or possibly an invasive procedure should be performed.<\/p><p>Other reasons for test failure include the existence of an egg donation about which was not informed. With the subsequent information of an egg donation, the Harmony<sup>&reg;<\/sup>&nbsp;Test can usually obtain a result.<\/p><p>Transplantations or previously unknown (and in general benign) maternal chromosomal disorders can also lead to a failure of the test. For these cases the Harmony<sup>&reg;<\/sup>&nbsp;Test is not validated and should not be performed or repeated.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2058\" class=\"elementor-tab-title\" data-tab=\"8\" role=\"button\" aria-controls=\"elementor-tab-content-2058\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Confirmation of the positive result through an invasive diagnostic method<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2058\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"8\" role=\"region\" aria-labelledby=\"elementor-tab-title-2058\"><p>Despite significant improvements over former non-invasive tests, the detection rate for the Harmony<sup>&reg;<\/sup>&nbsp;Prenatal Test is not 100%. False-positive results may occure.&nbsp;Therefore the Harmony<sup>&reg;<\/sup>&nbsp;Prenatal Test should be regarded as a screening test and not a diagnostic test. A positive (abnormal) result should therefore always be confirmed by a second, diagnostic method (<a class=\"encyclopedia\" title=\"Invasive collection of placental cells through the cervix or abdominal wall to detect chromosomal diseases for prenatal diagnostics.\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/chorionic-villus-sampling\/\" target=\"_self\">chorionic villus sampling<\/a>&nbsp;or&nbsp;<a class=\"encyclopedia\" title=\"see amniocentesis\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/amniotic-puncture\/\" target=\"_self\">amniotic puncture<\/a>) with a subsequent&nbsp;<a class=\"encyclopedia\" title=\"A chromosome is an complex of tightly-coiled DNA and the proteins which hold the structure together. Normal human cells contain 23 pairs of chromosomes - 22 autosomes and the X and Y sex chromosomes.\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/chromosome\/\" target=\"_self\">chromosome<\/a>&nbsp;analysis.<\/p><p>False-negative results are also possible. This is more common for&nbsp;<a class=\"encyclopedia\" title=\"Trisomy 13 occurs when there are three copies of chromosome 13. This leads to the development of Patau syndrome.\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy-13\/\" target=\"_self\">trisomy 13<\/a>.<\/p><p>The Harmony<sup>&reg;<\/sup>&nbsp;Test detects around 30 out of 32 <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy-13\/\" target=\"_self\" title=\"Trisomy 13 occurs when there are three copies of chromosome 13. This leads to the development of Patau syndrome.\" class=\"encyclopedia\">trisomy 13<\/a> cases in its current version.&nbsp;<span class=\"tlid-translation translation\"><span class=\"\" title=\"\">A summary of all previous studies on <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy-13\/\" target=\"_self\" title=\"Trisomy 13 occurs when there are three copies of chromosome 13. This leads to the development of Patau syndrome.\" class=\"encyclopedia\">trisomy 13<\/a> revealed an average detection rate of<\/span><\/span>&nbsp;93,8%&nbsp;<sup class=\"footnote\"><a id=\"fnref-615-7\" href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fn-615-7\">7<\/a><\/sup>. <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy-13\/\" target=\"_self\" title=\"Trisomy 13 occurs when there are three copies of chromosome 13. This leads to the development of Patau syndrome.\" class=\"encyclopedia\">Trisomy 13<\/a> is, however, relatively easy to detect in an ultrasound scan during first <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trimester\/\" target=\"_self\" title=\"Trimester is the medical term used to describe the division of a pregnancy into three phases of three months each.\" class=\"encyclopedia\">trimester<\/a> screening.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-908662e elementor-widget elementor-widget-text-editor\" data-id=\"908662e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ol><li><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22572044\" target=\"_blank\" rel=\"noopener\">Ashoor G, Poon L, Syngelaki A, Mosimann B, Nicolaides KH. Fetal Fraction in Maternal Plasma Cell-Free DNA at 11&ndash;13 Weeks&rsquo; Gestation: Effect of Maternal and Fetal Factors. Fetal Diagn Ther 2012;31:237-243.<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-1\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-2\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/23553731\" target=\"_blank\" rel=\"noopener\">Wang E, Batey A, Struble C, Musci T, Song K, Oliphant A. Gestational age and maternal weight effects on fetal cell-free DNA in maternal plasma. Prenat Diagn. 2013 Jul;33(7):662-6. doi: 10.1002\/pd.4119. Epub 2013 May 9.<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-2\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-3\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/25297464\" target=\"_blank\" rel=\"noopener\">Bevilacqua E, Gil MM, Nicolaides KH, Ordo&ntilde;ez E, Cirigliano V, Dierickx H, Willems PJ, Jani JC. Performance of screening for aneuploidies by cell-free DNA analysis of maternal blood in twin pregnancies. Ultrasound Obstet Gynecol. 2015 Jan;45(1):61-6. doi: 10.1002\/uog.14690. Epub 2014 Dec 4.<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-3\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-4\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/24247435\" target=\"_blank\" rel=\"noopener\">Gil MM, Quezada MS, Bregant B, Syngelaki A, Nicolaides KH. Cell-free DNA analysis for trisomy risk assessment in first-trimester twin pregnancies. Fetal Diagn Ther. 2014;35(3):204-11. doi: 10.1159\/000356495. Epub 2013 Nov 15.<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-4\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-5\"><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/32804406\/\" target=\"_blank\" rel=\"noopener\">L&uuml;thgens K, Grati FR, Sinzel M, H&auml;big K, Kagan KO. Confirmation rate of cell free DNA screening for sex chromosomal abnormalities according to the method of confirmatory testing. Prenat Diagn. 2020 Aug 17. doi: 10.1002\/pd.5814. Epub ahead of print. PMID: 32804406.<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-5\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-6\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=10.1002%2Fuog.18905\" target=\"_blank\" rel=\"noopener\">Kagan, K. O., Sroka, F., Sonek, J., Abele, H., L&uuml;thgens, K., Schmid, M., Wagner, P., Brucker, S., Wallwiener, D. and Hoopmann, M. (), First trimester screening based on ultrasound and cfDNA vs. first-trimester combined screening &ndash; a randomized controlled study. Ultrasound Obstet Gynecol. Accepted Author Manuscript. doi:10.1002\/uog.18905<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-6\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-7\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/26332378\" target=\"_blank\" rel=\"noopener\">Stokowski R, Wang E, White K, Batey A, Jacobsson B, Brar H, Balanarasimha M, Hollemon D, Sparks A, Nicolaides K, Musci TJ.: Clinical performance of non-invasive prenatal testing (NIPT) using targeted cell-free DNA analysis in maternal plasma with microarrays or next generation sequencing (NGS) is consistent across multiple controlled clinical studies. Prenat Diagn. 2015 Sep 1<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-7\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-8\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=Schmid+M+et+al.+Fetal+Diagn+Ther.+2017\" target=\"_blank\" rel=\"noopener\">Schmid M et al. Prenatal Screening for 22q11.2 Deletion Using a Targeted Microarray-Based Cell-Free DNA Test.Fetal Diagn Ther. 2017 Nov 8, E-pub ahead of print<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-8\">&#8617;<\/a><\/span><\/li><li>van Eekhout JCA, Bax CJ, Schuurman LVP, Becking EC, van der Ven AJEM, Van Opstal D, Boon EMJ, Macville MVE, Bekker MN, Galjaard RJH; Dutch <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/nipt\/\" target=\"_self\" title=\"Non-invasive prenatal tests are molecular genetic analyses in prenatal diagnostics to detect fetal chromosomal anomalies from the maternal blood, avoiding the risk of miscarriage inherent in more invasive methods.\" class=\"encyclopedia\">NIPT<\/a> Consortium. Performance of non-invasive prenatal testing in vanishing-twin and multiple pregnancies: results of TRIDENT-2 study. Ultrasound Obstet Gynecol. 2025 Sep 6. doi: 10.1002\/uog.70015. Epub ahead of print. PMID: 40913805.<\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-89e7ef2 elementor-section-stretched elementor-hidden-desktop elementor-hidden-tablet elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"89e7ef2\" data-element_type=\"section\" data-e-type=\"section\" data-settings='{\"stretch_section\":\"section-stretched\"}'>\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-a2de5b1\" data-id=\"a2de5b1\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6a41688 elementor-widget elementor-widget-heading\" data-id=\"6a41688\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Limitations of the Harmony&reg; Test<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-342f29f elementor-widget elementor-widget-text-editor\" data-id=\"342f29f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<header class=\"entry-content-header\"><header class=\"entry-content-header\"><p><a class=\"encyclopedia\" title=\"Non-invasive prenatal tests are molecular genetic analyses in prenatal diagnostics to detect fetal chromosomal anomalies from the maternal blood, avoiding the risk of miscarriage inherent in more invasive methods.\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/nipt\/\" target=\"_self\">NIPT<\/a>&nbsp;(non-invasive prenatal test) methods such as the Harmony<sup>&reg;<\/sup>&nbsp;Test are used to detect chromosomal disorders (trisomies 21, 18, 13, and X\/Y). What makes this method special is that it is non-invasive: only the mother&rsquo;s blood is tested.<\/p><p>A <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/nipt\/\" target=\"_self\" title=\"Non-invasive prenatal tests are molecular genetic analyses in prenatal diagnostics to detect fetal chromosomal anomalies from the maternal blood, avoiding the risk of miscarriage inherent in more invasive methods.\" class=\"encyclopedia\">NIPT<\/a> method, however, cannot replace an ultrasound scan in the first&nbsp;<a class=\"encyclopedia\" title=\"Trimester is the medical term used to describe the division of a pregnancy into three phases of three months each.\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trimester\/\" target=\"_self\">trimester<\/a>. First <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trimester\/\" target=\"_self\" title=\"Trimester is the medical term used to describe the division of a pregnancy into three phases of three months each.\" class=\"encyclopedia\">trimester<\/a> screening and\/or ultrasound scan towards the end of the first <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trimester\/\" target=\"_self\" title=\"Trimester is the medical term used to describe the division of a pregnancy into three phases of three months each.\" class=\"encyclopedia\">trimester<\/a> can detect possible disorders in the&nbsp;<a class=\"encyclopedia\" title=\"Relating to the unborn child\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\">fetal<\/a>&nbsp;organs and is still strongly recommended.<\/p><\/header><\/header>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3699e31 elementor-widget elementor-widget-toggle\" data-id=\"3699e31\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5721\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-5721\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Mosaicism, partial trisomies or translocations<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-5721\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-5721\"><p><a class=\"encyclopedia\" title=\"cell free fetal DNA: during pregnancy, the mother's blood contains not only maternal DNA but also cell-free fetal DNA\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/cffdna\/\" target=\"_self\">cffDNA<\/a>-based <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/nipt\/\" target=\"_self\" title=\"Non-invasive prenatal tests are molecular genetic analyses in prenatal diagnostics to detect fetal chromosomal anomalies from the maternal blood, avoiding the risk of miscarriage inherent in more invasive methods.\" class=\"encyclopedia\">NIPT<\/a> methods are not yet able to detect <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/chromosomal-mosaic\/\" target=\"_self\" title=\"Simultaneous presence of more than one cell lineage in an individual, each of which may have differing genetic content in terms of the number and structure of their chromosomes.\" class=\"encyclopedia\">chromosomal mosaic<\/a>ism, partial trisomies or <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/translocation\/\" target=\"_self\" title=\"Translocation is the relocation of one chromosome section to a different position within a set of chromosomes.\" class=\"encyclopedia\">translocation<\/a>s.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5722\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-5722\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Proportion of cell-free fetal DNA<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-5722\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-5722\"><p>In order to ensure the detection of a chromosomal disorder in the unborn child, the proportion of cell-free <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">fetal<\/a> <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/dna\/\" target=\"_self\" title=\"Deoxyribonucleic acid: biomolecule and carrier of genetic information\" class=\"encyclopedia\">DNA<\/a> (<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/cffdna\/\" target=\"_self\" title=\"cell free fetal DNA: during pregnancy, the mother's blood contains not only maternal DNA but also cell-free fetal DNA\" class=\"encyclopedia\">cffDNA<\/a>) (&ldquo;<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">Fetal<\/a> Fraction&rdquo;) in the mother&rsquo;s blood must be at least 4%&nbsp;<sup class=\"footnote\"><a id=\"fnref-615-1\" href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fn-615-1\">1<\/a><\/sup>. The Harmony<sup>&reg;<\/sup>&nbsp;Test can be performed after pregnancy week 10+0 because the proportion of <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">fetal<\/a> <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/dna\/\" target=\"_self\" title=\"Deoxyribonucleic acid: biomolecule and carrier of genetic information\" class=\"encyclopedia\">DNA<\/a> in the mother&rsquo;s blood rises with the length of the pregnancy (see figure below).<\/p><div id=\"attachment_606\" class=\"wp-caption aligncenter\"><a style=\"text-align: left; font-size: 1rem;\" href=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/SSW_cffDNA_EN.jpg\" target=\"_blank\" rel=\"noopener\"><img fetchpriority=\"high\" decoding=\"async\" class=\"wp-image-21970 size-full\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/SSW_cffDNA_EN.jpg\" alt=\"\" width=\"1432\" height=\"809\" srcset=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/SSW_cffDNA_EN.jpg 1432w, https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/SSW_cffDNA_EN-300x169.jpg 300w, https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/SSW_cffDNA_EN-1024x579.jpg 1024w, https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/SSW_cffDNA_EN-768x434.jpg 768w\" sizes=\"(max-width: 1432px) 100vw, 1432px\"><\/a><span style=\"color: var( --e-global-color-astglobalcolor1 ); text-align: left; font-size: 1rem;\"> Figure 1: Relationship of the &ldquo;<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">Fetal<\/a> Fraction&rdquo; and the week of pregnancy (<\/span><a class=\"encyclopedia\" style=\"text-align: left; font-size: 1rem;\" title='Schwangerschaftswoche (German for \"week of pregnancy\").' href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/ssw\/\" target=\"_self\">SSW<\/a><span style=\"color: var( --e-global-color-astglobalcolor1 ); text-align: left; font-size: 1rem;\">) <br>(modified acc. to&nbsp;<\/span><sup class=\"footnote\" style=\"color: var( --e-global-color-astglobalcolor1 ); text-align: left;\"><a id=\"fnref-615-2\" href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fn-615-2\">2<\/a><\/sup><span style=\"color: var( --e-global-color-astglobalcolor1 ); text-align: left; font-size: 1rem;\">)<\/span><\/div><p style=\"text-align: left;\">There is also a correlation between the mother&rsquo;s weight and the &ldquo;<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">Fetal<\/a> Fraction&rdquo;: the higher the mother&rsquo;s weight, the lower the proportion of <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">fetal<\/a> <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/dna\/\" target=\"_self\" title=\"Deoxyribonucleic acid: biomolecule and carrier of genetic information\" class=\"encyclopedia\">DNA<\/a> in the mother&rsquo;s blood.<\/p><div id=\"attachment_338\" class=\"wp-caption aligncenter\"><a href=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/Abhaengigkeit-der-Fetal-Fraction-vom-muetterlichen-Gewicht.jpg\"><img decoding=\"async\" class=\"aligncenter wp-image-259 size-full\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/Abhaengigkeit-der-Fetal-Fraction-vom-muetterlichen-Gewicht.jpg\" alt=\"\" width=\"1496\" height=\"930\" srcset=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/Abhaengigkeit-der-Fetal-Fraction-vom-muetterlichen-Gewicht.jpg 1496w, https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/Abhaengigkeit-der-Fetal-Fraction-vom-muetterlichen-Gewicht-300x186.jpg 300w, https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/Abhaengigkeit-der-Fetal-Fraction-vom-muetterlichen-Gewicht-1024x637.jpg 1024w, https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/Abhaengigkeit-der-Fetal-Fraction-vom-muetterlichen-Gewicht-768x477.jpg 768w\" sizes=\"(max-width: 1496px) 100vw, 1496px\"><\/a><\/div><div class=\"wp-caption aligncenter\" style=\"text-align: left;\">For every Harmony<sup>&reg;<\/sup>&nbsp;Test the &ldquo;<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">Fetal<\/a> Fraction&rdquo; is measured. If the <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">Fetal<\/a> Fraction is below 4%, the test cannot be evaluated. The sender will be informed that a new blood sample should be submitted at a slightly later date (approximately after 3 weeks). The patient will not be charged for tests that cannot be evaluated.<\/div><div><div id=\"footnotes-251\" class=\"footnotes\"><div class=\"footnotedivider\">&nbsp;<\/div><\/div><\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5723\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-5723\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Secret egg donation<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-5723\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-5723\"><p>The Harmony<sup>&reg;<\/sup>&nbsp;Test can be performed irrespective of the manner of conception or origin of the ovum. Due to specialized bioinformatics analyses, however, by filling out the test requisition form it must be informed about an egg donation when the test is requested. If an egg donation is kept secret, the Harmony<sup>&reg;<\/sup>&nbsp;Test is not able to deliver a result.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5724\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-5724\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Vanishing twin<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-5724\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-5724\"><p>In the case of a vanishing twin, we recommend performing the Harmony&reg; test no earlier than the 15th week of pregnancy, or at least eight weeks after the death of the second fetus<sup class=\"footnote\">9<\/sup>. This is because the placenta of the deceased twin often persists for several weeks, continuing to release cell-free <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/dna\/\" target=\"_self\" title=\"Deoxyribonucleic acid: biomolecule and carrier of genetic information\" class=\"encyclopedia\">DNA<\/a>.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5725\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-5725\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Transplant, malignancy or maternal aneuploidy<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-5725\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-5725\"><p>The Harmony<sup>&reg;<\/sup>&nbsp;Test is not validated for use in pregnancies with maternal <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/aneuploidie\/\" target=\"_self\" title=\"An abnormal number of chromosomes in a cell; for example, there may be a copy of a chromosome missing, or extra, in a cell.\" class=\"encyclopedia\">aneuploidy<\/a>, transplant or malignancy.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5726\" class=\"elementor-tab-title\" data-tab=\"6\" role=\"button\" aria-controls=\"elementor-tab-content-5726\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">X\/Y analysis in twins<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-5726\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"6\" role=\"region\" aria-labelledby=\"elementor-tab-title-5726\"><p>The Harmony&reg; test can be used for twin pregnancies.<\/p><p>A recent study by Judah et al. (2021) on twin analyses found that the detection and false-positive rates for <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy-21\/\" target=\"_self\" title=\"Trisomy 21 is the most common numerical chromosomal disorder in newborns. There are three copies of chromosome 21 and this leads to the development of Down syndrome.\" class=\"encyclopedia\">trisomy 21<\/a> are comparable to those of singleton pregnancies<sup>9<\/sup>. The publication shows that <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/cfdna\/\" target=\"_self\" title=\"cell free DNA: DNA fragments that naturally circulate freely in the bloodstream.\" class=\"encyclopedia\">cfDNA<\/a>-based screening for the three relevant trisomies in Gemini pregnancies consistently outperforms first <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trimester\/\" target=\"_self\" title=\"Trimester is the medical term used to describe the division of a pregnancy into three phases of three months each.\" class=\"encyclopedia\">trimester<\/a> screening.<\/p><p>Judah et al.&rsquo;s meta-analysis was based on the Nicolaides group&rsquo;s studies with the Harmony&reg; test and publications with <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/mpss\/\" target=\"_self\" title=\"Massively parallel shotgun sequencing: the amplification and sequencing of maternal and fetal DNA; the proportion of chromosomes represented in a sample is compared to what is expected for those chromosomes.\" class=\"encyclopedia\">MPSS<\/a>* methods. The detection and false-positive rates for noninvasive prenatal testing (<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/nipt\/\" target=\"_self\" title=\"Non-invasive prenatal tests are molecular genetic analyses in prenatal diagnostics to detect fetal chromosomal anomalies from the maternal blood, avoiding the risk of miscarriage inherent in more invasive methods.\" class=\"encyclopedia\">NIPT<\/a>) in twin pregnancies are<sup>9<\/sup>:<\/p><table><tbody><tr><td><a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy\/\" target=\"_self\" title=\"Trisomy means that there are three copies (trisom) of a complete or partial chromosome, instead of the normal two (disom).\" class=\"encyclopedia\">Trisomy<\/a><\/td><td>Detection rate<\/td><td>False positive rate<\/td><td>Number of <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy\/\" target=\"_self\" title=\"Trisomy means that there are three copies (trisom) of a complete or partial chromosome, instead of the normal two (disom).\" class=\"encyclopedia\">trisomy<\/a> cases<\/td><td>Number of euploid gemini pregnancies<\/td><\/tr><tr><td>21<\/td><td><center>99,0 %<\/center><\/td><td><center>0,02 %<\/center><\/td><td><center>137<\/center><\/td><td><center>7507<\/center><\/td><\/tr><tr><td>18<\/td><td><center>92,8 %<\/center><\/td><td><center>0,01 %<\/center><\/td><td><center>50<\/center><\/td><td><center>6840<\/center><\/td><\/tr><tr><td>13<\/td><td><center>94,7 %<\/center><\/td><td><center>0.10 %<\/center><\/td><td><center>11<\/center><\/td><td><center>6290<\/center><\/td><\/tr><\/tbody><\/table><p>Currently, it is not possible to make a statement about sex chromosomal disorders (X\/Y analysis), such as Turner or <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/klinefelter-syndrome\/\" target=\"_self\" title=\"This chromosomal disorder affects males and is characterised by an extra X-chromosome in all, or in a proportion, of the cells of the body. Further information about Klinefelter syndrome can be found here.\" class=\"encyclopedia\">Klinefelter syndrome<\/a>, for twins.<\/p><p>The table below shows which Harmony&reg; test variant is possible for which pregnancy.<br>\n<\/p><table id=\"tablepress-4-no-2\" class=\"tablepress tablepress-id-4\">\n<tbody>\n<tr class=\"row-1\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\">Singleton pregnancies<\/td><td class=\"column-3\">Twin pregnancies<\/td><td class=\"column-4\">More than two fetuses<\/td>\n<\/tr>\n<tr class=\"row-2\">\n\t<td class=\"column-1\">Harmony&reg; T21\/T18\/T13<\/td><td class=\"column-2\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/haken.png\" alt=\"Haken\" width=\"25\" height=\"27\" class=\"alignnone size-full wp-image-1356\"><\/td><td class=\"column-3\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/haken.png\" alt=\"Haken\" width=\"25\" height=\"27\" class=\"alignnone size-full wp-image-1356\"><\/td><td class=\"column-4\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/h_kreuz.png\" alt=\"h_kreuz\" width=\"19\" height=\"19\" class=\"alignnone size-full wp-image-1359\"><\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">Harmony&reg; T21\/18\/13 + X\/Y-Analysis<\/td><td class=\"column-2\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/haken.png\" alt=\"Haken\" width=\"25\" height=\"27\" class=\"alignnone size-full wp-image-1356\"><\/td><td class=\"column-3\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/h_kreuz.png\" alt=\"h_kreuz\" width=\"19\" height=\"19\" class=\"alignnone size-full wp-image-1359\"><\/td><td class=\"column-4\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/h_kreuz.png\" alt=\"h_kreuz\" width=\"19\" height=\"19\" class=\"alignnone size-full wp-image-1359\"><\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\">sex determination<\/td><td class=\"column-2\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/haken.png\" alt=\"Haken\" width=\"25\" height=\"27\" class=\"alignnone size-full wp-image-1356\"><\/td><td class=\"column-3\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/haken.png\" alt=\"Haken\" width=\"25\" height=\"27\" class=\"alignnone size-full wp-image-1356\"><\/td><td class=\"column-4\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.cenata.de\/wp-content\/uploads\/2016\/11\/h_kreuz.png\" alt=\"h_kreuz\" width=\"19\" height=\"19\" class=\"alignnone size-full wp-image-1359\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Sex determination is possible for both singleton and twin pregnancies. In accordance with the Genetic Diagnostics Act, the <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">fetal<\/a> sex is communicated from week 14+0 (p.m.) onwards.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5727\" class=\"elementor-tab-title\" data-tab=\"7\" role=\"button\" aria-controls=\"elementor-tab-content-5727\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Limitations of the Harmony&reg;&nbsp;Test<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-5727\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"7\" role=\"region\" aria-labelledby=\"elementor-tab-title-5727\"><p>In a very small number of cases, the Harmony<sup>&reg;<\/sup>&nbsp;Test cannot be performed successfully<sup class=\"footnote\"><a id=\"fnref-615-5\" href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fn-615-5\">5<\/a><\/sup>&nbsp;<sup class=\"footnote\"><a id=\"fnref-615-6\" href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fn-615-6\">6<\/a><\/sup>. This is usually because the proportion of cell-free <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/fetal\/\" target=\"_self\" title=\"Relating to the unborn child\" class=\"encyclopedia\">fetal<\/a> <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/dna\/\" target=\"_self\" title=\"Deoxyribonucleic acid: biomolecule and carrier of genetic information\" class=\"encyclopedia\">DNA<\/a> (<a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/cffdna\/\" target=\"_self\" title=\"cell free fetal DNA: during pregnancy, the mother's blood contains not only maternal DNA but also cell-free fetal DNA\" class=\"encyclopedia\">cffDNA<\/a>) in the blood is too low for a result to be obtained. In such a case we recommend blood be taken again at a later point (after 2 weeks) and the Harmony<sup>&reg;<\/sup>&nbsp;Test be repeated. In our experience, 50% of the second submissions can then be succesfully evaluated. In case a test result cannot be obtained, a decision has to be made with the patient as to whether further first <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trimester\/\" target=\"_self\" title=\"Trimester is the medical term used to describe the division of a pregnancy into three phases of three months each.\" class=\"encyclopedia\">trimester<\/a> screening or possibly an invasive procedure should be performed.<\/p><p>Other reasons for test failure include the existence of an egg donation about which was not informed. With the subsequent information of an egg donation, the Harmony<sup>&reg;<\/sup>&nbsp;Test can usually obtain a result.<\/p><p>Transplantations or previously unknown (and in general benign) maternal chromosomal disorders can also lead to a failure of the test. For these cases the Harmony<sup>&reg;<\/sup>&nbsp;Test is not validated and should not be performed or repeated.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5728\" class=\"elementor-tab-title\" data-tab=\"8\" role=\"button\" aria-controls=\"elementor-tab-content-5728\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-plus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-minus-square\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Confirmation of the positive result through an invasive diagnostic method<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-5728\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"8\" role=\"region\" aria-labelledby=\"elementor-tab-title-5728\"><p>Despite significant improvements over former non-invasive tests, the detection rate for the Harmony<sup>&reg;<\/sup>&nbsp;Prenatal Test is not 100%. False-positive results may occure.&nbsp;Therefore the Harmony<sup>&reg;<\/sup>&nbsp;Prenatal Test should be regarded as a screening test and not a diagnostic test. A positive (abnormal) result should therefore always be confirmed by a second, diagnostic method (<a class=\"encyclopedia\" title=\"Invasive collection of placental cells through the cervix or abdominal wall to detect chromosomal diseases for prenatal diagnostics.\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/chorionic-villus-sampling\/\" target=\"_self\">chorionic villus sampling<\/a>&nbsp;or&nbsp;<a class=\"encyclopedia\" title=\"see amniocentesis\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/amniotic-puncture\/\" target=\"_self\">amniotic puncture<\/a>) with a subsequent&nbsp;<a class=\"encyclopedia\" title=\"A chromosome is an complex of tightly-coiled DNA and the proteins which hold the structure together. Normal human cells contain 23 pairs of chromosomes - 22 autosomes and the X and Y sex chromosomes.\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/chromosome\/\" target=\"_self\">chromosome<\/a>&nbsp;analysis.<\/p><p>False-negative results are also possible. This is more common for&nbsp;<a class=\"encyclopedia\" title=\"Trisomy 13 occurs when there are three copies of chromosome 13. This leads to the development of Patau syndrome.\" href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy-13\/\" target=\"_self\">trisomy 13<\/a>.<\/p><p>The Harmony<sup>&reg;<\/sup>&nbsp;Test detects around 30 out of 32 <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy-13\/\" target=\"_self\" title=\"Trisomy 13 occurs when there are three copies of chromosome 13. This leads to the development of Patau syndrome.\" class=\"encyclopedia\">trisomy 13<\/a> cases in its current version.&nbsp;<span class=\"tlid-translation translation\"><span class=\"\" title=\"\">A summary of all previous studies on <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy-13\/\" target=\"_self\" title=\"Trisomy 13 occurs when there are three copies of chromosome 13. This leads to the development of Patau syndrome.\" class=\"encyclopedia\">trisomy 13<\/a> revealed an average detection rate of<\/span><\/span>&nbsp;93,8%&nbsp;<sup class=\"footnote\"><a id=\"fnref-615-7\" href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fn-615-7\">7<\/a><\/sup>. <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trisomy-13\/\" target=\"_self\" title=\"Trisomy 13 occurs when there are three copies of chromosome 13. This leads to the development of Patau syndrome.\" class=\"encyclopedia\">Trisomy 13<\/a> is, however, relatively easy to detect in an ultrasound scan during first <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/trimester\/\" target=\"_self\" title=\"Trimester is the medical term used to describe the division of a pregnancy into three phases of three months each.\" class=\"encyclopedia\">trimester<\/a> screening.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d7d4eb5 elementor-widget elementor-widget-text-editor\" data-id=\"d7d4eb5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ol><li><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22572044\" target=\"_blank\" rel=\"noopener\">Ashoor G, Poon L, Syngelaki A, Mosimann B, Nicolaides KH. Fetal Fraction in Maternal Plasma Cell-Free DNA at 11&ndash;13 Weeks&rsquo; Gestation: Effect of Maternal and Fetal Factors. Fetal Diagn Ther 2012;31:237-243.<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-1\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-2\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/23553731\" target=\"_blank\" rel=\"noopener\">Wang E, Batey A, Struble C, Musci T, Song K, Oliphant A. Gestational age and maternal weight effects on fetal cell-free DNA in maternal plasma. Prenat Diagn. 2013 Jul;33(7):662-6. doi: 10.1002\/pd.4119. Epub 2013 May 9.<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-2\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-3\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/25297464\" target=\"_blank\" rel=\"noopener\">Bevilacqua E, Gil MM, Nicolaides KH, Ordo&ntilde;ez E, Cirigliano V, Dierickx H, Willems PJ, Jani JC. Performance of screening for aneuploidies by cell-free DNA analysis of maternal blood in twin pregnancies. Ultrasound Obstet Gynecol. 2015 Jan;45(1):61-6. doi: 10.1002\/uog.14690. Epub 2014 Dec 4.<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-3\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-4\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/24247435\" target=\"_blank\" rel=\"noopener\">Gil MM, Quezada MS, Bregant B, Syngelaki A, Nicolaides KH. Cell-free DNA analysis for trisomy risk assessment in first-trimester twin pregnancies. Fetal Diagn Ther. 2014;35(3):204-11. doi: 10.1159\/000356495. Epub 2013 Nov 15.<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-4\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-5\"><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/32804406\/\" target=\"_blank\" rel=\"noopener\">L&uuml;thgens K, Grati FR, Sinzel M, H&auml;big K, Kagan KO. Confirmation rate of cell free DNA screening for sex chromosomal abnormalities according to the method of confirmatory testing. Prenat Diagn. 2020 Aug 17. doi: 10.1002\/pd.5814. Epub ahead of print. PMID: 32804406.<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-5\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-6\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=10.1002%2Fuog.18905\" target=\"_blank\" rel=\"noopener\">Kagan, K. O., Sroka, F., Sonek, J., Abele, H., L&uuml;thgens, K., Schmid, M., Wagner, P., Brucker, S., Wallwiener, D. and Hoopmann, M. (), First trimester screening based on ultrasound and cfDNA vs. first-trimester combined screening &ndash; a randomized controlled study. Ultrasound Obstet Gynecol. Accepted Author Manuscript. doi:10.1002\/uog.18905<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-6\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-7\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/26332378\" target=\"_blank\" rel=\"noopener\">Stokowski R, Wang E, White K, Batey A, Jacobsson B, Brar H, Balanarasimha M, Hollemon D, Sparks A, Nicolaides K, Musci TJ.: Clinical performance of non-invasive prenatal testing (NIPT) using targeted cell-free DNA analysis in maternal plasma with microarrays or next generation sequencing (NGS) is consistent across multiple controlled clinical studies. Prenat Diagn. 2015 Sep 1<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-7\">&#8617;<\/a><\/span><\/li><li id=\"fn-615-8\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=Schmid+M+et+al.+Fetal+Diagn+Ther.+2017\" target=\"_blank\" rel=\"noopener\">Schmid M et al. Prenatal Screening for 22q11.2 Deletion Using a Targeted Microarray-Based Cell-Free DNA Test.Fetal Diagn Ther. 2017 Nov 8, E-pub ahead of print<\/a>&nbsp;<span class=\"footnotereverse\"><a href=\"https:\/\/www.cenata.de\/en\/for-physicians\/limitations-of-the-harmony-test\/#fnref-615-8\">&#8617;<\/a><\/span><\/li><li>van Eekhout JCA, Bax CJ, Schuurman LVP, Becking EC, van der Ven AJEM, Van Opstal D, Boon EMJ, Macville MVE, Bekker MN, Galjaard RJH; Dutch <a href=\"https:\/\/www.cenata.de\/en\/encyclopedia\/nipt\/\" target=\"_self\" title=\"Non-invasive prenatal tests are molecular genetic analyses in prenatal diagnostics to detect fetal chromosomal anomalies from the maternal blood, avoiding the risk of miscarriage inherent in more invasive methods.\" class=\"encyclopedia\">NIPT<\/a> Consortium. Performance of non-invasive prenatal testing in vanishing-twin and multiple pregnancies: results of TRIDENT-2 study. Ultrasound Obstet Gynecol. 2025 Sep 6. doi: 10.1002\/uog.70015. Epub ahead of print. PMID: 40913805.<\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Highest Standard.For your patients. Highest Standard.For your patients. Highest Standard.For your patients. FOR PHYSICIANS SEARCH Limitations of the Harmony\u00ae Test NIPT\u00a0(non-invasive prenatal test) methods such as the Harmony\u00ae\u00a0Test are used to detect chromosomal disorders (trisomies 21, 18, 13, and X\/Y). What makes this method special is that it is non-invasive: only the mother\u2019s blood is [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":594,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-615","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.cenata.de\/en\/wp-json\/wp\/v2\/pages\/615","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.cenata.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.cenata.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.cenata.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.cenata.de\/en\/wp-json\/wp\/v2\/comments?post=615"}],"version-history":[{"count":151,"href":"https:\/\/www.cenata.de\/en\/wp-json\/wp\/v2\/pages\/615\/revisions"}],"predecessor-version":[{"id":32948,"href":"https:\/\/www.cenata.de\/en\/wp-json\/wp\/v2\/pages\/615\/revisions\/32948"}],"up":[{"embeddable":true,"href":"https:\/\/www.cenata.de\/en\/wp-json\/wp\/v2\/pages\/594"}],"wp:attachment":[{"href":"https:\/\/www.cenata.de\/en\/wp-json\/wp\/v2\/media?parent=615"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}