定性测定性能评价卫生行业标准WS/T 505-2017附录B示例错误和纠正

Errors in Appendix B examples of WS/T 505—2017 and correction

《定性测定性能评价指南》(WS/T505-2017,简称WS/T505-2017)是国内临床实验室对定性测定项目进行性能验证或方法学比较的权威指南。指南中的示例分析是临床实验室和厂商校验数据分析正确性的重要依据,但在涉及方法学比较的附录B示例中存在一些错误,有可能给使用者带来困扰。文章用关联公式拆解三方比较表,分析并纠正附录B示例中的错误;通过与WS/T505—2017和美国临床实验室标准化协会EP12-A2标准相同和等效的公式分析、纠正计算错误,并补充其他的计算方法进行结果验证,以帮助临床实验室正确使用该标准。

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.