目的:评价以胶乳免疫比浊法原理研制的C反应蛋白快速定量检测试剂盒的方法学性能。方法测定试剂盒的检测限、精密度、线性范围、回收率、贮存稳定性,将检测200份样本的结果与国外试剂盒比较。结果检测限为0.72 mg/L,精密度:高、低浓度水平的样本批内变异系数分别为3.09%、6.75%,批间变异系数分别为6.47%、6.84%;线性范围为1~215 mg/L,线性相关系数为0.99;平均回收率为112.5%,系统误差<1/2TEa。贮存有效期:18个月。200份不同浓度样本测定结果与进口试剂盒比较差异无统计学意义。结论研制的C反应蛋白快速定量检测试剂盒符合临床检测要求。%Objective To evaluate the quality and performance of self-made C-reactive protein test kit ( latex immunoturbi-dimetry).Methods The limitation of detection,precision,linearity,recovery,expiry term was measured.200 blood samples were used for the comparative study with imports .Results Limitation of detection:0.72 mg/L.Precision:the within-run relative standard devia-tions of two different concentration samples were 3.09%and 6.75%.The day to day relative standard deviations of two different con-centration samples were 6.47%and 6.84%.Linearity:the linear range was from 1 mg/L to 215 mg/L.The correlation coefficient was 0.99.Accuracy:the average recovery was 112.5%.The system error was less than 1/2TEa.Expiry term:18 months.Contrast experi-ment:the results between self-made C-reactive protein test kit and imports had no significant difference .Conclusion The test kit is a valueable diagnostic tool for C-reactive protein rapid and accurate detection .
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