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.
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.
The FORTE (Fetal-fraction Optimized Risk of Trisomy Evaluation Dynamic Linked Library) software is a cornerstone of the Harmony® Test. It enables the analysis of fetal cell-free DNA (cfDNA) from the maternal plasma, in order to determine the gender of the fetus, the risk for trisomy 21, 18 and 13 and for X and Y chromosomal aneuploidies.
Cenata confirms that the FORTE algorithm, which is being used as part of the Harmony® Test, is CE marked in accordance with the European IVD guidelines (directive 98/79/EC; annex II, list B).
The Harmony® Test is the only NIPT performed in Germany, whose algorithm is CE certified for all chromosomal abnormalities under investigation.
The blood collection tubes which are provided as part of the Harmony® Test are also CE certified by the manufacturer.