两种降钙素原定量检测试剂盒的比较分析

Comparative analysis of two kinds of procalcitonin quantitive detection kit

目的比较DiaSorin S.p.A.公司的降钙素原(PCT)定量检测试剂盒(化学发光法)与已上市的同类产品检测结果的一致性和定量检测的相关性,判断其是否符合临床使用要求。方法选取2017年1月血浆标本105例,同时用两种试剂盒进行检测,对检测结果进行一致性,相关性等分析;选取同源血清/血浆配对样本52例,用DiaSorin试剂盒进行检测,分析检测结果的相关性。结果cutoff值为0.5ng/mL时,两种检测试剂盒分析的一致性为96.19%;cutoff值为2.0ng/mL时,两种检测试剂盒分析的一致性为95.24%。两种试剂盒检测结果的相关系数为0.987,具有显著相关性(P<0.01);同源血清/血浆配对样本检测结果的相关系数为0.989,结果高度一致(P<0.01)。结论两种试剂盒具有等效性。

Objective To compare the coincidence rate and the correlation of quantitative detection between the procalcitonin(PCT)quantitative detection kit(chemiluminescent immunoassay)researched and developed by DiaSorin S.p.A.and the marketed similar products to judge whether the developed product meeting the clinical use requirements.Methods105cases plasma samples collected in janury2017were detected by the two kinds of reagent kit.The consistency and correlation were analyzed;52cases of the homologous serum/plasma samples were detected by DiaSorin reagent kit,the correlation was analyzed.Results When the cut off value was0.5ng/mL.the analysis consistency of the two kinds of reagent kit was96.19%;When the cut off value was2.0ng/mL,which was95.24%.The correlation of the two kinds of reagent kit was0.987,showing the detection results by the two kinds of reagent kit had a significant correlation(P<0.01);the correlation of the homologous serum/plasma samples was0.989,has highly consistent(P<0.01).Conclusion The two kinds of reagent kit possess the equivalence.