C 反应蛋白快速定量检测试剂盒性能评价

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。

Evaluation of the quality and performance of self-made C-reactive protein test kit

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 .