Liquid Biopsy
[Liquid Biopsy]
EPTIS Ringversuch Nr. 1588086 | Letze Änderung 2026-08-20 | URL: https://www.eptis.bam.de/pts1588086 https://www.eptis.bam.de/pts1588086
| Name des Anbieters | ||||||||||||||||
| Name des Anbieters | Berufsverband Deutscher Humangenetiker e.V. Berufsverband Deutscher Humangenetiker e.V. | |||||||||||||||
| Ansässig in | Germany | |||||||||||||||
| Sprache(n) | English, German | |||||||||||||||
| Anmerkungen | 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. | |||||||||||||||
| Klassifizierung | ||||||||||||||||
| Produktgruppen |
Human test material
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| Prüfgebiete |
Medical analysis
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| Technische Einzelheiten | ||||||||||||||||
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| Ringversuchsziele | ||||||||||||||||
| Zielgruppe des Ringversuchs | Any laboratories that use Liquid Biopsy as a standard procedure. There are no geographical restrictions to participation. | |||||||||||||||
| Relevante Rechtsvorschriften oder Normen | ||||||||||||||||
| Weitere Ziele | validation of testing methods | |||||||||||||||
| Teilnehmerzahl | 10 | |||||||||||||||
| Anbieter unabhängig überprüft (akkreditiert, benannt, anerkannt) |
Akkreditiert durch Deutsche Akkredtierungs-Stelle, DAkkS auf der Grundlage von DIN EN ISO/IEC 17043:2023 Bundesärztekammer (RiliBÄK) |
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| Die Durchführung des Ringversuchs ist in Auftrag gegeben durch | Germany: Bundesärztekammer/RiliBÄK | |||||||||||||||
| Kosten | ||||||||||||||||
| Teilnahmegebühr | Set 1: 250 €, Set 2: 250 €, Set 3: 350 € (net), plus shipping costs | |||||||||||||||
| Regelmässig durchgeführt | Ja (twice per year) | |||||||||||||||
| Der Ringversuch wird durchgeführt seit | 2025 | |||||||||||||||
| Kontaktdaten des Anbieters | ||||||||||||||||
| Anbieter | Kontaktperson | |||||||||||||||
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Berufsverband Deutscher Humangenetiker e.V.
Linienstraße 127 10115 Berlin Germany Telefon: 030 55954411 Fax: 030 55954414 Web: https://www.bvdh-ringversuche.de https://www.bvdh-ringversuche.de |
Frau Susanne Brandt
Telefon: 02403 838054 Fax: E-Mail: brandt@bvdh.de brandt@bvdh.de |
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