3种干式化学分析仪用于献血前 ALT 筛查的性能验证

摘要

目的：根据干式化学分析仪行业标准 YY/T0655-2008对3种干式化学分析仪进行了使用情况的对比分析。方法以罗氏 Cobas P800全自动生化分析仪为参考仪器，对3种干式化学分析仪的准确度、批内精密度、线性等进行评估。结果3种干式化学分析仪符合行业标准 YY/T0655-2008规定要求，但进口设备的精密度明显优于国产设备。结论为了保证各仪器间检测结果的可比性和一致性，应对仪器进行定期校准和比对实验，校准比对的前提应以 CLIA′88指标的1/4的精密度水平为指标，而不能满足于 YY/T0655-2008的精密度要求，唯有这样才能避免血液的浪费和献血者流失。%Objective To perform the comparative analysis on the use situation of 3 kinds of dry chemical analyzers according to the industrial standards YY/T0655-2008.Methods With the Roche Cobas P800 automatic biochemical analyzers as the reference instrument,the accuracy,intra-assay precision,linearity,etc.in 3 kinds of dry chemical analyzers were evaluated.Results 3 kinds of dry chemical analyzers met the requirements of the industrial standards YY/T0655-2008,but the precision of imported instrument was significantly better than that of the domestic instrument.Conclusion In order to ensure the comparability and consistency of the detection results among instruments,the instruments should be regularly calibrated and performed the comparative experi-ments,the premise of calibration and comparison should be using 1/4 of the precision level in the CLIA′88 indicators as the indica-tor,not satisfying with the precision requirements in YY/T0655-2008,only in this way can the waste of blood and donors going a-way be avoided.