免疫透射比浊法CRP检测试剂盒的性能评价

Evaluation of the performance characteristic of CRP turbidimetric immunoassay reagent kit

目的评价日本(ITARON)CRP试剂盒检测C反应蛋白(CRP)的可靠性。方法分别用ITARON试剂盒与西班牙BioSystems试剂盒、德国Human试剂盒同时对50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IATRON试剂进行评价。结果IATRON与其它两种进口试剂的相关系数均为0.998,差异无显著性(P>0.05);用IATRON试剂盒检测二种质控物的相对误差分别为3.33%及0.29%;重复性试验显示批内变异系数为2.48%,批间变异系数为2.72%;线性试验显示检测浓度在10mg/dl以内呈良好线性。结论IATRON试剂测定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 evaluate the reliability of ITARON turbidimetric immunoassay reagent kit in measuring C - reaction protein （CRP）. Methods 50 samples were measured by using ITARON, BioSystems and Human reagent kit synchronously. The linear range, accuracy and precision of reagent kit were analyzed. Results The CRP concentrations determined by ITARON reagent kit were in correlation with the others two kits （ r = 0. 998, P 〉 0. 05 ）. The relative error of measuring two controls was 3.33% and 0.29% respectively. The average intra- and inter-assay coefficients of variation （CV） were 2.48% and 2.72% respectively. The linear range is 10mg/dl. Conclusion The ITARON turbidimetrie immunoassay reagent kit is precise, accurate in the determination of CRP and and suitable for clinical use.