强生Vitros 5.1 FS生化分析仪上乳酸脱氢酶的性能验证

目的探讨强生Vitros 5.1 FS生化分析仪上乳酸脱氢酶(LDH)的性能验证。方法根据美国临床和实验室标准化协会的检测仪器评价标准,并参照美国强生公司提供的验证方案对LDH的精密度、正确度、线性范围、最大稀释度、生物参考区间进行验证。结果 LDH批内及批间精密度试验均≤3.30%;正确度试验≤4.00%;线性试验决定系数为0.997 2;LDH用生理盐水稀释最大稀释度为8倍;生物参考区间试验证实《VITROS方法学手册》提供的参考区间313~618U/L可以引用。结论强生Vitros 5.1 FS生化分析仪检测的LDH性能验证基本符合质量目标要求和厂商说明要求,满足临床检验的需求。

Performance verification of lactate dehydrogenase in Johnson Vitros 5 .1 FS biochemical analyzer

Objective To study the performance verification of lactate dehydrogenase(LDH) in the Johnson Vitros 5 .1 FS bio‐chemical analyzer .Methods According to CLSI instrumentation evaluation standard and referring to the validation scheme provided by the Johnson company ,the precision ,accuracy ,linear range of LDH ,maximum dilution degree ,biological reference range were verified .Results The LDH intra‐batch and inter‐batch precision experiments were≤3 .30% ;the accuracy experiment≤4 .00% ;the determination coefficient of the linear experiment was 0 .997 2 ;the LDH maximum dilution degree was 8 times with saline solution dilution;the biological reference range experiment verified that the reference range 313-618 U/L provided by the VITROS Meth‐odology Manual could be quote .Conclusion The performance verification of LDH detected by the Johnson Vitros 5 .1 FS biochemi‐cal analyzer basically conforms to the requirements of the quality objectives and manufacturer′s instructions ,and meets the needs of clinical test .