SysmexCA-1500自动凝血分析仪的性能

Performance Verification of Sysmex CA-1500 Automatic Coagulation Analyzer

目的评价Sysmex CA-1500自动凝血分析仪检测系统的分析性能。方法按美国临床实验室标准化协会(CLSI)的指南文件EP5-A2,EP15-A2,EP6-A2的要求以及中国行业标准文件等对Sysmex CA-1500自动凝血分析仪的精密度、准确度、线性范围、可报告范围、携带污染率等主要性能进行验证,并与厂商声明的性能或公认的质量标准进行比较。结果批内精密度小于1/4 TEa,日间精密度和总精密度小于1/3 TEa(CLIA 88);对卫生部10份室间质评物检测结果与靶值进行比对全部满分,显示准确度良好;线性范围与厂商提供的性能指标相符;携带污染率影响很小,完全可以满足实验要求。结论 Sysmex CA-1500自动凝血分析仪检测系统精密度、准确度、线性范围、可报告范围、携带污染率等主要性能均达到了相关标准的要求。

Objective The performance of the detection systemof of SysmexCA-1500 automatic blood coagulation analyzer was verified according to the ＂Management methods of clinical laboratory in medical institution＂ and ISO15189 ＂medical laboratory quality and criteria for recognition＂ . Methods According to the American Association of Clinical Laboratory Standardization（CLSI） Guidelines EP5-A2, EP15-A2, EP6-A2 requirements and Chinese Industry Standard File on Sysmex CA-]500 Automatic Blood Coagulation Analyzer, the precision, accuracy, linear range, reportable range, carrying contamination rate of main performance were verified, and were compared with the performance of the manufacturers statement or recognized quality standards. Results The precision in the batch to be less than 1/4 TEa, daytime precision and total precision is less than a third TEa （CLIA 88）; The test results of 10 parts of the Ministry of Health were compared with the target values, and the results showed that the accuracy was good. The linear range is consistent with the performance indicators provided by the manufacturer; the pollution rate is very small, which can meet the requirements of the experiment. Conclusion The precision, accuracy, linear range, reporlable range, carry contamination rate of main performance of SysmexCA-1500 automatic blood coagulation analyzer test system has reached the requirement of the standards in the laboratory.