C-反应蛋白仪的性能评价

EVALUATION OF C-REACTION PROTEIN ASSAY MACHINE

[目的]评价国产C-反应蛋白仪能否应用于临床。[方法]根据CLSI方法学评价的要求,对不精密度、不准确度、功能灵敏度、可报告范围等进行综合评价,并对有关数据统计分析。[结果]批内、天间重复变异系数分别小于允许误差的1/4、1/3,具有较好的精密度;C-反应蛋白在160mg/L以下时准确度能够满足临床要求;功能灵敏度浓度1.28mg/L;CRP可报告范围小于160mg/L。[结论]本实验室性能评价的部分数据与厂商承诺的性能指标有差异,但可以在儿童医院投入临床使用。

[ Objective] To evaluate the value and feasibility of C-reaction protein assay machine for clinical test. [Methods] Generally assayed the imprecision, inaccuracy, sensitivity and reportable range of the machine according to CLSI and made statistic analysis. [Results] Variation coefficients in different batch sample were less than a quarter of acceptable error; on the other hand, variation coefficients in different days sample were less than a third of acceptable error. There was a better precision. Especially CRP test had very good performance when the concentration of CRP lower than 160mg/L, and function sensitivity of test was 1.28mg/L. The reportable range of this test was less than 160mg/L. [Conclusion ] The assay results show the difference of specification and data are partially different with those marked by manufacturer, but it still can satisfy the clinical test requests in children＇s hospital.