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Biosafety Virtual Library Resources
(VLR)
last updated: 25 Mar 2026
Guidelines for the validation of qualitative real-time PCR methods by means of a collaborative study
EN
Organization:Federal Office of Consumer Protection and Food Safety (BVL)Government agency (National/Federal)Department Genetic Engineering and other Biotechnological Processes Gerichtstr. 49Berlin,
13347, GermanyPhone: +49-(0)3018 44440500,Fax:Email: german_bch@bvl.bund.de,
German Federal Officie of Consumer Protection and Food Safety (BVL, Bundesamt für Verbraucherschutz und Lebensmittelsicherheit)
EN
2016-03
EN
- BVL website [ English ]
- BVL Homepage [ German ]
- Leitlinien_zur_Ringversuchs_Validierung.pdf ( Leitlinien, Ringversuchs-Validierung, qualitativen, real-time PCR ) [ German ]
- Guidelines_for_the_validation_of_qualitative.pdf ( validation, ring-trial, collaborative, real-time PCR ) [ English ]
The present guidelines for conducting a collaborative validation study 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 respective methods can meet the performance criteria defined at the European (ENGL, CEN) and international (ISO, Codex) level. The main criterion for validation a qualitative real-time PCR method by means of a collaborative study is determining the false-positive rate and false-negative rate. However, the robustness of the method can also be derived from the study as different laboratories use different real-time PCR equipment. On the basis of a mathematical-statistical model for the validation of the probability of detection (POD) of qualitative PCR methods, performance characteristics regarding laboratory standard deviation, mean amplification probability and LOD95% (across laboratories) can be computed.
EN
- Germany
- GBF-T17. Strengthen biosafety and distribute benefits of biotechnology
No
No
No
The procedure described in this document is a recommendation that is underpinned by practical experience but alternative approaches for which it can be shown that performance criteria are achieved can be applied.
Please consider that a qualitative real-time PCR method should first undergo single-laboratory validation before being tested in a collaborative study (refer to BCH-VLR-SCBD-293575-1 ).
Please consider that a qualitative real-time PCR method should first undergo single-laboratory validation before being tested in a collaborative study (refer to BCH-VLR-SCBD-293575-1 ).
