临床实验室验证试剂测定范围的方法研究

Methods study of validating reagent measurement range in clinical laboratory

目的建立临床实验室试剂测定范围,对实验室验证试剂测定范围的方法进行探讨。方法选取丙氨酸氨基转移酶测定试剂盒[国际临床化学联合会(IFCC)推荐法],参照《GB/T 26124-2011临床化学体外诊断试剂盒》标准规定方法,建立该试剂的测定范围,验证是否在试剂生产厂家给定的测定范围内。结果临床实验室建立的丙氨酸氨基转移酶测定范围为6～1 000 U/L,相关系数(r)=0.999 6,相对偏差的绝对值小于或等于3.63%,在试剂厂家给定的测定范围内。结论临床实验室应该根据实际情况,选择符合实验室要求的试剂。

Objective To establish the reagent measurement range for the clinical laboratory according to the standard of the Clinical Chemistry in Vitro Diagnostic Kits in GB/T 26124-2011 and to validate whether the established range is within the measurement range given by the reagent manufacturer.Methods The alanine aminotransferase（ALT） assay kit recommended by the international federation of clinical chemistry（IFCC） was selected and the reagent measurement range was established according to the standard of the Clinical Chemistry in Vitro Diagnostic Kits in GB/T 26124-2011.Whether or not the established measurement range within the range given by the reagent manufacturer was validated.Results The reagent measurement range in the clinical labortory was 6-1 000 U/L,the correlation coefficient（r） was 0.999 6 and the absolute value of the relative deviation was no more than 3.63% within the dectection range given by the reagent manufacturer.Conclusion The clinical laboratory should choose the reagents conforming to the laboratory requirement according to the actual situation.