Prenatal rapid test
[Pränataler Schnelltest]
EPTIS factsheet 1349718 | Last revision 2025-04-10 | URL: https://www.eptis.bam.de/pts1349718 https://www.eptis.bam.de/pts1349718
| PT provider | ||||||||||||||||
| PT provider | Berufsverband Deutscher Humangenetiker e.V. Berufsverband Deutscher Humangenetiker e.V. | |||||||||||||||
| Based in | Germany | |||||||||||||||
| Language(s) | Deutsch, English | |||||||||||||||
| Remarks | There are two different methods to check prenatal samples (e.g. amniotic fluid) without cell culture for the most relevant trisomies 13, 18 and 21 and for gonosomal aneuploidies. This EQA test checks the technical performance of the interphase-FISH or QF-PCR technique, the evaluation of the data, the reporting and the interpretation of the results in order to simulate a real diagnostic setting. In a second task the formal knowledge is proved (e.g. ISCN nomenclature, interpretation). Samples are shipped through courier service. The interphase FISH or the QF-PCR test should be carried out according to the own laboratory SOP. A diagnostic report has to be written and uploaded which includes the result of the analysis and the interpretation in relation to the diagnostic question. It is possible to upload the lab protocols, too. A second task consists of a theoretical task (e.g. ISCN nomenclature). | |||||||||||||||
| Keywords | ||||||||||||||||
| Product groups |
Human test material
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| Testing fields |
Medical analysis
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| Technical details | ||||||||||||||||
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| Aims of the PT scheme | ||||||||||||||||
| Target group of participants | Human Genetic laboratories | |||||||||||||||
| Linked to specific legislation / standards | ||||||||||||||||
| Additional, subsidiary aims | validation of testing methods | |||||||||||||||
| Number of participants | 60 | |||||||||||||||
| Accredited or otherwise reviewed by a 3rd party |
Accredited by Deutsche Akkreditierungsstelle (DAkkS) on the basis of DIN EN ISO 17043 German Medical Association |
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| Operation is commissioned / requested by | ||||||||||||||||
| Fees and frequency | ||||||||||||||||
| Participation fee | Information is available on the homepage (www.bvdh-ringversuche.de) | |||||||||||||||
| Regularly operated | Yes (Once per year) | |||||||||||||||
| Year of first operation | 2005 | |||||||||||||||
| Contact details of the PT provider | ||||||||||||||||
| Provider | Contact person | |||||||||||||||
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Berufsverband Deutscher Humangenetiker e.V.
Linienstraße 127 10115 Berlin Germany Phone: 030 55954411 Fax: 030 55954414 Web: https://www.bvdh-ringversuche.de https://www.bvdh-ringversuche.de |
Frau Susanne Brandt
Phone: 02403 838054 Fax: Email: brandt@bvdh.de brandt@bvdh.de |
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