不同色原物葡萄糖检测试剂性能比较

Performance comparison among glucose detection reagents with different chromogens

目的根据照美国临床试验室标准化委员会(NCCLS)文件对3种不同色原物的葡萄糖检测试剂的性能进行初步评价,并对其抗干扰性能进行考察。方法按照NCCLS EP10-A2文件,使用3种不同色原物的葡萄糖检测试剂分别对葡萄糖低、中、高值标本进行检测,计算偏倚、总不精密度及其截距、斜率、携带污染、非线性、漂移性。根据EP7-A2文件,对检测试剂进行干扰评价试验。结果 3种试剂偏倚、总不精密度均在允许范围内,截距、斜率、携带污染、非线性、漂移性差异3均无统计学意义(P>0.05);1450浊度乳糜、5g/L血红蛋白和0.03g/L维生素C对3种不同色原物葡萄糖检测试剂的测定均无干扰;342mol/L游离胆红素、342mol/L结合胆红素对含MAOS色原物的葡萄糖试剂的检测无干扰。结论 3种不同色原物的葡萄糖检测试剂准确度和精密度良好,各性能指标基本符合临床要求,含MAOS色原物的试剂的抗干扰性优于其他色原物的试剂。

Objective To preliminarily evaluate the performance of glucose detention reagents with three kinds of different cbromogens and to investigate their anti-interference performance according to NCCLS document. Methods According to the protocol EP10-A2 provided by the National Committee for Clinical Laboratory Standards（NCCLS）, the samples with low, middle and high level of glucose were detected by the glucose reagent kits with 3 kinds of different chromogens. The bias, total imprecision, intercepts, slope rates, nonlinearities, carryover rate and drifts were calculated. The interference evaluation test was performed according to the document EP7-A2. Results The bias and total imprecision of three kinds of reagent kits were all within allowed ranges. No statistically significant differences were showed in intercepts, slope rates, nonlinearities, carryover rate and drifts. 1450 turbidity chyle, 5 g/L hematoglobin and 0.03 g/L vitamin C did not interfere with the assay of three kinds of glucose reagent kits with different chromogens. 342 μmol/L free bilirubin, 342 μmol/L conjugated bilirubin did not interfere with the detection of reagent with MAOS. Conclusion The glucose detention reagents with three different chromogens have good accuracy and precision,and various performance indexes all conform to the clinical application requirements, reagent with chromogen MAOS is better than other cbromogenic reagents in the anti-interference performance.