全程C反应蛋白检测试剂盒的性能验证

Verification of the performance characteristic of the ordinary and high sensitive CRP reagent kit

目的验证全程C反应蛋白（CRP）检测试剂盒的可靠性。方法用Beckman Coulter公司的试剂盒与全程CRP试剂盒同时对40例临床标本进行检测，并通过线性试验、准确性试验、重复性试验对全程CRP试剂盒进行性能验证。结果两种检测试剂的相关系数为0.996，差异无统计学意义（P〉0.05）；全程CRP检测试剂重复性试验显示批内变异系数为2.6％，批问变异系数为3.5％；线性试验显示检测浓度在0.06～32mg／dL以内呈良好线性。结论全程CRP试剂盒测定的CRP浓度具有较好的精密度，结果准确可靠，其性能符合临床使用要求。

Objective To verify the reliability of the ordinary and high sensitive CRP reagent kit . Methods 40 samples were measured by using the ordinary and high sensitive CRP and Backman COULTER reagent kit. The linear range,accuracy and precision of reagent kit were analyzed. Results The CRP concentrations determined by the ordinary and high sensitive CRP reagent kit was in correlation with Backman COULTER reagent kit（r 0. 996 ,P〉0.05）. The average intra- and inter-assay coefficients of variation（CV）were 2.6% and 3.5% respectively. The linear range is 0.06-32 mg/dL. Conclusion The ordinary and high sensitive reagent kit is precise,accurate in the determi- nation of CRP and suitable for clinical use.