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Ressources de la bibliothèque virtuelle sur le prévention des risques biotechnologiques
(VLR)
last updated: 25 mars 2026
Guidelines for the single-laboratory validation of qualitative real-time PCR methods
EN
Organisation :Federal Office of Consumer Protection and Food Safety (BVL)Agence gouvernementale (nationale/fédérale)Department Genetic Engineering and other Biotechnological Processes Gerichtstr. 49Berlin,
13347, AllemagneTéléphone : +49-(0)3018 44440500,Télécopieur :E-mail : german_bch@bvl.bund.de,
German Federal Officie of Consumer Protection and Food Safety (BVL, Bundesamt für Verbraucherschutz und Lebensmittelsicherheit)
EN
2016-11
FR
- BVL website [ English ]
- BVL Homepage [ Allemand ]
- Guidelines_for_the_single_laboratory.pdf ( guidance, validation, PCR, real-time, qualitative ) [ English ]
- Leitlinien_zur_Einzellabor_Validierung.pdf ( Leitlinien, Validierung, qualitativer, real-time PCR ) [ Allemand ]
The present guidelines for single-laboratory validation of qualitative real-time PCR methods were developed by the international working group "Development of methods for the identification of food produced by genetic engineering", established pursuant to § 64 of the German Food and Feed Code. It aims to ensure that qualitative real-time PCR methods developed by this group are able to meet the performance criteria defined at the European (ENGL, CEN) and international (ISO, Codex) level. The guideline describes the performance characteristics and the minimum performance criteria that should be taken into account when conducting a single-laboratory validation study for qualitative real-time PCR methods. Key aspects are the limit of detection, the specificity and the robustness of the method. The procedure described in this document constitutes a recommendation that has proven itself in practice.
EN
- Allemagne
- GBF-T17. Renforcer la prévention des risques biotechnologiques et partager les avantages liés aux biotechnologies
Non
Non
Non
These guidelines form the basis for the standard DIN EN ISO 11781:2025-07 Molecular biomarker analysis – Requirements and guidance for single-laboratory validation of qualitative real-time polymerase chain reaction (PCR) methods (ISO 11781:2025).
Furthermore, validation data gained from single-laboratory validation studies are taken into account to decide whether the method in question should be validated in a collaborative study to be, subsequently, included into the BVL’s Official Collection of Methods of Analysis. Please refer to record BCH-VLR-SCBD-293576-1
Furthermore, validation data gained from single-laboratory validation studies are taken into account to decide whether the method in question should be validated in a collaborative study to be, subsequently, included into the BVL’s Official Collection of Methods of Analysis. Please refer to record BCH-VLR-SCBD-293576-1
