CAJ | 학술논문

目的：评价终点法测定缺血修饰清蛋白（IM A ）试剂盒的性能，判断其分析性能是否满足临床要求。方法应用终点法测定血清中的IM A浓度，对试剂盒的精密度、正确度、线性及参考区间做出评价。精密度按照定量测量方法的精密度性能评价（EP5‐A2）指南标准进行评价；正确度按照定值参考物质检测的回收实验批准（EP15‐A ）指南标准进行评价；线性范围按照EP6‐A指南推荐方法进行评价；参考区间按照美国临床实验室标准化委员会（NCCLS）标准进行评价。结果该IMA试剂盒参考范围适用本实验室；线性良好，精密度、正确度均在规定范围内。结论该商品化IM A试剂盒符合实验室性能标准，性能良好，可供本实验室对大批量血清标本进行检测。
목적：평개종점법측정결혈수식청단백（IM A ）시제합적성능，판단기분석성능시부만족림상요구。방법응용종점법측정혈청중적IM A농도，대시제합적정밀도、정학도、선성급삼고구간주출평개。정밀도안조정량측량방법적정밀도성능평개（EP5‐A2）지남표준진행평개；정학도안조정치삼고물질검측적회수실험비준（EP15‐A ）지남표준진행평개；선성범위안조EP6‐A지남추천방법진행평개；삼고구간안조미국림상실험실표준화위원회（NCCLS）표준진행평개。결과해IMA시제합삼고범위괄용본실험실；선성량호，정밀도、정학도균재규정범위내。결론해상품화IM A시제합부합실험실성능표준，성능량호，가공본실험실대대비량혈청표본진행검측。
Objective To evaluate the performance of ischemia modified albumin(IMA) reagent kit utilized in endpoint method, and determine whether its analytical performance meet the clinical demand .Methods The endpoint method was used to detect serum IMA .The precision, accuracy, linearity and reference interval were evaluated by u‐sing the EP5‐A2 document, EP15‐A document, EP6‐A document and National Committee for Clinical Laboratory Standards(NCCLS) reference method, respectively .Results The reference interval of IMA reagent kit met the labo‐ratory demand, with good linearity, and the precision and accuracy of IMA reagent kit were in the specified ranges . Conclusion The commercial IMA kit might have good performance and could satisfy laboratory performance stand‐ards, which could be used in the detection of a large quantity of serum samples in this laboratory .