降钙素原检测试剂盒在SMART Ⅳ上的性能评价

Performance evaluation of procalcitonin assay kit on SMART Ⅳ

目的验证降钙素原(PCT)检测试剂盒在便携式快速检测仪器SMARTⅣ上的性能指标,对其性能进行评价。方法参考美国国家临床实验室标准化研究所(CLSI)的EP5-A2文件指南,通过重复测试80组样本,评价PCT检测试剂盒在SMARTⅣ上的精密度和变异系数;同时进行线性范围分析;收集不同浓度的新鲜样本(每天5份,连续5 d,共25份),分别在SMARTⅣ上及日立7180生化仪上进行测值,比较其相关性和一致性。结果 80组样本在SMARTⅣ上精密度良好,变异系数小,且在0.5 ng/ml^60 ng/ml浓度内具有良好线性,线性回归方程为y=1.008x+0.178 6,r2=0.996 9;样本在SMARTⅣ上和日立7180生化仪上的测值相关性好,具有较高的一致性。结论 PCT检测试剂盒在SMARTⅣ上具有良好的性能,且与日立7180生化仪进行比较,两者有较好的相关性和一致性,基层医疗机构可根据实际情况采用SMARTⅣ进行降钙素原的快速检测。

Objective To evaluate the performance of procalcitonin（ PCT） detection kit on the portable rapid detection instrument（ SMART IV）. Methods Refer to the CLSI EP5-A2 file guidebook of the National Institute of Clinical Laboratory Standards,80 samples were used to evaluate the precision and coefficient of PCT on SMART IV; the linear range was analyzed simultaneously; different concentrations of fresh samples（ 5 cases a day for five days,a total of 25 samples） were collected to compare the correlations and concentrations between the SMART IV and Hitachi 7180. Results The PCT detection kit showed good precision and small coefficient on SMART Ⅳ,linearity was good within 0. 5 ng/ml-60 ng/ml,in addition,equation of linear regression was y = 1. 008 x ＋ 0. 178 6,r2= 0. 996 9; the results between SMART Ⅳ and Hitachi 7180 had a good correlation and consistency. Conclusion The PCT detection kit has good performance on SMART Ⅳ,and good correlation and consistency were observed compared with Hitachi 7180. Therefore,grassroots medical institutions can detect PCT on SMART Ⅳ rapidly,according to the actual situation.