基于ISO15189要求的免疫学定性试验性能验证方法的探讨

To investigate the verification method for immunological qualitative test performance based on ISO15189 requirements

目的根据CNAS-CL39的要求,探讨定性试验的性能验证方法。方法以ELISA法检测HBsAg为例,以厂家给定的性能指标为验证依据,根据空白检出限及样本检出限的验证方法对检出限进行验证,按照EP15-A2标准验证该方法的精密度,采用验证方法与公认方法比较的2×2列联表验证该方法的符合率,采用收集的HBsAg阴性患者血清对cutoff值进行验证。结果检出限、精密度(重复性和中间精密度)、符合率、诊断临界值的验证结果均符合要求。结论本研究按照ISO15189和CNAS-CL39文件要求进行的免疫学定性试验性能验证方案是科学而适用的。

Objective To investigate the verification method for immunological qualitative test performance in accordance with CNAS-CL39 requirement. Methods HBsAg by ELISA method was taken as the example to verify the performance index based au- thentication methods, based on the detection limit of the blank and sample detection limit, according to the EP15 A2 standard au- thentication precision. A 2× 2 contingency table was taken to verify compliance rate of the method, HBsAg-negative patients were used to verify the value of the cut off value. Results The detection limit and precision are in accordance with the rate, the cut off value validation results are in accordance with requirements. Conclusion CNAS-CL39 file based immunological qualitative test per- formance verification program is scientific and applicable.