IVD validated kits versus Metrological Calibrated (q)PCR cyclers and IVD metrological
calibrated traceable kit validation
Date: 29-Aug-2025
SI-Traceable Calibration as a Prerequisite for Reliable IVD-(q)PCR
This document provides insight into the gaps and pitfalls that exist between IVD kit manufacturer
requirements and its ISO15189, ISO17025 users’ compliancy requirements