Liquid Biopsy
[Liquid Biopsy]
EPTIS factsheet 1588086 | Last revision 2026-08-20 | URL: https://www.eptis.bam.de/pts1588086 https://www.eptis.bam.de/pts1588086
| PT provider | ||||||||||||||||
| PT provider | Berufsverband Deutscher Humangenetiker e.V. Berufsverband Deutscher Humangenetiker e.V. | |||||||||||||||
| Based in | Germany | |||||||||||||||
| Language(s) | English, German | |||||||||||||||
| Remarks | The aim of this EQA test is to offer an external quality assurance measure for NGS analyses that covers the requirements of RiliBÄK 2023. The interlaboratory tests cover the laboratory procedure, variant prioritization and classification, report generation, and interpretation. Cases with annually changing clinical pictures will be offered. In addition to the hotspot variants mentioned in RiliBÄK, we will also offer participants the opportunity to analyze known pathogenic but rarer variants in the relevant genes. The EQA test comprises 3 independent sets of test items: Set 1: a cfDNA sample in artificial plasma (NSCLC - EGFR) Set 2: a cfDNA sample in artificial plasma (NSCLC - BRAF, KRAS, NRAS) Set 3: a cfDNA sample in artificial plasma (breast cancer - ESR1, and PIK3CA) The plasma samples will be sent by mail or courier service, depending on the destination. Further information (tasks, criteria, etc.) will be available for download. A brief medical history will be provided. The laboratories should treat the samples as diagnostic cases, process them using their ctDNA detection workflow, and prepare a findings report. For this EQA test, participants will receive a certificate from the BVDH e. V. for the sets they have completed upon successful participation; in the case of successful participation in Set 1/Set 2, this will include the RiliBÄK supplement. The certificate is valid for two years. | |||||||||||||||
| 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 | Any laboratories that use Liquid Biopsy as a standard procedure. There are no geographical restrictions to participation. | |||||||||||||||
| Linked to specific legislation / standards | ||||||||||||||||
| Additional, subsidiary aims | validation of testing methods | |||||||||||||||
| Number of participants | 10 | |||||||||||||||
| Accredited or otherwise reviewed by a 3rd party |
Accredited by Deutsche Akkredtierungs-Stelle, DAkkS on the basis of DIN EN ISO/IEC 17043:2023 Bundesärztekammer (RiliBÄK) |
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| Operation is commissioned / requested by | Germany: Bundesärztekammer/RiliBÄK | |||||||||||||||
| Fees and frequency | ||||||||||||||||
| Participation fee | Set 1: 250 €, Set 2: 250 €, Set 3: 350 € (net), plus shipping costs | |||||||||||||||
| Regularly operated | Yes (twice per year) | |||||||||||||||
| Year of first operation | 2025 | |||||||||||||||
| 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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