抗米勒管激素测定试剂盒性能验证

Performance Verification of the Anti-Mullerian Hormone Testing Kit

目的:对罗氏的AMH试剂盒进行性能验证,评估其是否满足临床应用。方法:参考美国临床和实验室标准协会(CLSI)的标准要求,制定方案,对罗氏AMH试剂盒的准确度、精密度、线性范围、临床可报道范围、参考区间等性能进行验证,比较厂家试剂盒说明书,评价其性能是否通过验证。结果:准确度验证其检测结果与理论值的相对偏倚均在5%范围以内,未超过厂家及临床的允许范围;试剂批内精密度均<2.00%,均<5.00%,符合厂家说明书要求;在厂家说明书0.01~23ng/mL的线性范围内,试剂线性较好,符合临床应用标准;试剂最大稀释倍数为64倍,临床最大可报告范围浓度为1472ng/mL,最低检测限为0.0011;参考范围验证表明检测值均在厂家说明书提供的参考区间范围内。结论:试剂盒的准确度、精密度、线性范围、临床可报道范围、参考区间等性能符合厂家说明书所公布的性能,满足临床检验应用。

Objective:To verify the performance of Roche’s AMH kit and evaluate whether it meets the clinical application.Methods:Referring to the standard requirements of the American Society for clinical and laboratory standards(CLSI),a scheme was formulated to verify the accuracy,precision,linear range,clinically reportable range and reference interval of Roche AMH kit,compare the manufacturer’s kit instructions,and evaluate whether its performance passed the verification.Results:The relative bias between the test results and the theoretical value was within 5%,which did not exceed the allowable range of the manufacturer and clinic.The precision within the reagent batch is less than 2.00%and less than 5.00%,which meets the requirements of the manufacturer’s instructions.Within the linear range of 0.01-23ng/mL in the manufacturer’s instructions,the reagent has good linearity and meets the clinical application standard.The maximum dilution ratio of the reagent is 64 times,the maximum clinically reportable concentration is 1472ng/mL,and the minimum detection limit is 0.0011.The verification of reference range shows that the detection values are within the reference range provided by the manufacturer’s instructions.Conclusion:The accuracy,precision,linear range,clinical coverage range and reference interval of the kit conform to the performance published in the manufacturer’s instructions and meet the clinical test application.