乳酸脱氢酶参考方法性能评价及影响因素分析

The performance evaluation of lactate dehydrogenase reference method and the analysis of the influence factors

目的为推动参考方法在检验结果准确性溯源方法学中的应用,运用国际临床化学联合会(IFCC)参考方法测定乳酸脱氢酶(LDH)。通过比较和分析参加参考实验室国际比对计划乳酸脱氢酶的测定结果,对本实验室应用参考方法测定乳酸脱氢酶进行性能评价及影响因素分析。方法按照IFCC有关酶学活性测定(37℃)参考方法的标准操作程序(SOP)测定C.f.a.s、有证参考物质和乳酸脱氢酶国际样本。结果国际样本和C.f.a.s的变异系数均<1%;国际样本测定结果均在IFCC公布的置信区间内,总偏倚在±1.5%以内;有证参考物质测定结果在给定的不确定度范围内。结论乳酸脱氢酶IFCC参考方法测定日趋成熟,测定结果稳定、准确。

Objective In order to improve the application of reference methods in the traceability of test results measuring lac- tate dehydrogenase （LDH） by reference methods of International Federation of Clinical Chemistry （IFCC）. By comparison and analysis of the reference laboratory of the international comparison programme of lactate dehydrogenase determination results, an- alyzed the laboratory reference method determination of lactate dehydrogenase （LDH） for performance evaluation and factor. Methods Acorrding to the IFCC related enzyme activity determination （37 ℃ ） reference method of standard operating proce- dures （SOP） , measured C. f. a. s, European reference materials and international lactate dehydrogenase sample. Results The results of coefficient of variation （CV） were less than 1%. The extent of the overall was bias within ± 1.5%. Determination of lactate dehydrogenase results of international sample were announced at the IFCC within the limit of equivalence. Results of European reference material （ERM） were within the stated uncertainty. Conclusion The application of determination of lactate dehydrogenase according to IFCC reference method is increasingly mature and the determination of the results is stable and accurate.