CAJ | 학술논문

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、5 g／L 血红蛋白和0．03 g／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；342 mol／L游离胆红素、342 mol／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。
목적：근거조미국림상시험실표준화위원회（NCCLS）문건대3충불동색원물적포도당검측시제적성능진행초보평개，병대기항간우성능진행고찰。방법안조 NCCLS EP10-A2문건，사용3충불동색원물적포도당검측시제분별대포도당저、중、고치표본진행검측，계산편의、총불정밀도급기절거、사솔、휴대오염、비선성、표이성。근거 EP7-A2문건，대검측시제진행간우평개시험。결과3충시제편의、총불정밀도균재윤허범위내，절거、사솔、휴대오염、비선성、표이성차이3균무통계학의의（P＞0．05）；1450탁도유미、5 g／L 혈홍단백화0．03 g／L 유생소 C 대3충불동색원물포도당검측시제적측정균무간우；342 mol／L유리담홍소、342 mol／L 결합담홍소대함 MAOS 색원물적포도당시제적검측무간우。결론3충불동색원물적포도당검측시제준학도화정밀도량호，각성능지표기본부합림상요구，함 MAOS 색원물적시제적항간우성우우기타색원물적시제。
Objective To preliminarily evaluate the performance of glucose detention reagents with three kinds of different chro-mogens 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,inter-cepts,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 differ-ent 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 chro-mogenic reagents in the anti-interference performance.