This standard specifies methods for clinical laboratories to verify the analytical performance of commercial quantitative kits. This standard is suitable for clinical laboratories to verify the analytical performance of commercial quantitative kits. It may not be fully applicable to some commercial quantitative kits, and appropriate modifications can be made based on this standard. This standard is not suitable for a comprehensive and systematic evaluation of the analytical performance of commercial quantitative kits. If the clinical laboratory has made major modifications to the operating procedures, dosage, calculations, etc. of the commercial quantitative kit, verification alone is not enough. In this case, a more comprehensive and complex confirmation method should be used.
WS/T 420-2013 Referenced Document
GB/T 22576-2008 Medical laboratories.Particular requirements for quality and competence
WS/T 420-2013 history
2013WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory