Confirmation rate (PPV) of screening for sex chromosomal abnormalities with the Harmony Test depends on the method of confirmatory testing

In a current study in collaboration with Prof. Oliver Kagan (University Hospital Tübingen) and Francesca Grati (TOMA Advanced Biomedical Assays SpA, Impact Lab Group), published in Prenatal Diagnosis in August 2020, the positive predictive value (PPV) in screening for gonosomal aneuploidies (sex chromosomal aneuploidies [SCA]) was determined.

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DAkkS Accreditation DIN EN ISO 15189: 2014

Our laboratory has been accredited since September 2019 by the DAkkS  according to DIN EN ISO 15189: 2014. The accreditation applies to the scope of accreditation listed in the attachment [D-ML-21205-01-00]. This accreditation certifies medical laboratories a very high standard of quality and competence.

Harmony Test laboratory analysis requires only 3 working days

For pregnant women and their families, waiting for the results of a prenatal test is often a huge mental burden. We are pleased to inform you that Cenata has reduced the analysis time for the Harmony® Test by 25% – to just three working days in average. This means that the results of the Harmony® Test are now usually available to the requesting physician within 3 working days.

The time required for analysis has been shortened by working in a shift system which allows us to run analyses daily. The laboratory analysis of the Harmony® Test comprises the following steps that result in the high sensitivity and specificity of the Harmony® Test:

In some cases it can still happen that the test must be repeated for technical reasons. In case of a delay the requesting physician will be informed immediately that the reporting will be delayed by about three days.

The decreased reporting time does not influence the high quality and validity of the Harmony® Test. Nothing in the test design is changed. Of course, the improvement in processing time does not result in any additional costs for the patient.

Please contact us if you have any questions.