Guidelines for the single-laboratory validation of qualitative real-time PCR methods

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).

Link to german version “Leitlinien zur Einzellabor-Validierung qualitativer real-time PCR Methoden“

download file "Guidelines for the single-laboratory validation of qualitative real-time PCR methods" (PDF, 527KB, File does not meet accessibility standards; English)

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Guidelines for the single-laboratory validation of qualitative real-time PCR methods