Abstract:

The guideline for evaluation of qualitative test performance （WS/T 505—2017） is the authoritative guide for the performance verification or methodological comparison of qualitative determination items in domestic clinical laboratories. The example analysis in the guideline is an important basis for clinical laboratories and vendors to verify the correctness of datum analysis，but there are some errors in the Appendix B examples involving methodological comparisons that may cause confusion to users. This paper analyzes and corrects errors in the Appendix B examples using the association formula disassembled three-way comparison table，analyzes and corrects calculation errors using formulas that are identical and equivalent to WS/T 505—2017 and the Clinical and Laboratory Standards Institute EP12-A2，and complements other calculation methods for result validation，with a view to helping clinical laboratories use the guideline correctly.

Key words: Qualitative determination, Performance evaluation, Health standard, Clinical laboratory, Error