一款新型糖化血红蛋白床旁检测系统线性评价

The Linearity Evaluation of a New Hemoglobin A1c Analyzer(HbA1c) for Point-of-Care Testing(POCT)

目的对一款新型床旁检测(point-of-care testing,POCT)糖化血红蛋白(HbA1c)分析仪的线性进行评价,从而对这仪器及试剂进行初步评价。方法根据临床和实验室标准化协会(CLSI)EP6-A文件,配制11个HbA1c浓度为等间距排列的试验样本。按随机顺序对它们进行测定,每个样本重复测定两次,对试验数据进行多项式回归分析。结果测定结果未发现离群点。试验样本的不精密度变异系数(CVr)为2.4%。二次回归多项式非线性系数b_2与0之间的差异无统计学意义(P=0.743),三次回归多项式非线性系数b_2、b_3与0之间的差异无统计学意义(P=0.869、0.847),最适多项式为一次多项式,最适方程为Y=0.971X+2.899(r=0.998)。结论该HbA1c检测系统在3.90%~13.45%范围内呈线性,该试剂盒申明的线性范围与本验证试验结果一致。

Objective To evaluate the linearity of a new hemoglobin A1 c analyzer for point-of-care testing, as well as its instrument and test kit. Methods According to the EP6-A document, described by Clinical and Laboratory Standards Institute （CLSI）, 11 HbAlc concentrations of equal spaced were prepared as test samples, which were measured in duplicate in random order. Then the data were analyzed with polynomial regression analysis. Results No outlier was found in all the results. The coefficient variation of imprecision （CVr） is 2.4%. There was no statistically significant difference between zero and nonlinear coefficient b2 ~b3 in quadratic regression polynomial （P = 0. 869,0. 847 ）, and the linear equation was optimal. The regression equation of HbA1 c was Y = 0.971X ＋ 2.899 （r = 0. 998 ）. Conclusion The HbA1 c test kit was linear in the range of 3.90% - 13.45%, and the linear range stated in the kit was consistent with the results of this validation test.