超敏C反应蛋白试剂盒线性范围的验证

摘要

目的 验证本科室使用的超敏C反应蛋白(hs-CRP)试剂盒的线性范围,对该试剂盒的性能进行初步评价.方法 根据临床和实验室标准化协会(CLSI)制定的EP6-A2文件,配制6个试验样本,按随机顺序对它们进行测定,每个样本重复测定2次.经离群点检查后,计算比例误差(CVr)、多项式回归系数(bi)、残差(Bij)、标准误(Syx)、线性偏离(DLi).结果 所有测试结果未发现离群点,CVr为0.40%,小于试剂盒说明书的批内不精密度要求.二次回归多项式非线性系数b2、三次回归多项式非线性系数b3与0之间差异有统计学意义(P＜0.05).二次回归多项式、三次回归多项式的Syx分别为0.029 3、0.018 7,三次回归多项式为最适多项式.6个试验样本的DLi最大值为1.22%,小于美国临床病理学家协会(CAP)要求的非线性差异要求(2.5%).结论 本科室使用的hs-CRP试剂盒在0～20.5 mg/L范围内呈线性,与试剂盒申明的线性范围相一致.%Objective To demonstrate the linear range of high sensitive C reactive protein(hs CRP) assay kit used in this labo ratory, and evaluate the performance of this kit preliminarily. Methods According to the EP6 A2 document, described by Clinical and Laboratory Standards Institute(CLSI), 6 samples were prepared, which were detected in duplicate in random order. After out Her test, the proportional error (CVc), polynomial regression coefficients (bi) , residual(Bij ) , standard error (Syz ) and deviation from linearity(Dli) were calculated. Results No outlier was found in all test results, and the CVr was 0. 40% , less than the with in run imprecision requirements of kit instructions. There was a statistically significant difference between zero and nonlinear coeffi cient b2 in quadratic regression polynomial(P-<0. 05) , so was b3 in cubic regression polynomial(P<0. 05). The Syx of quadratic re gression polynomial and cubic regression polynomial were 0. 029 3 and 0. 018 7 respectively, and the cubic regression polynomial was optimal. The maximum Dli was 1. 22% , less than the nonlinear difference requirements of College of American Pathologists (CAP). Conclusion The hs CRP assay kit used in this laboratory might be with linear range from 0 to 20. 5 mg/L, in accordance with statement of kit instructions.