CAJ | 학술논문

目的：采用光激化学发光免疫分析技术建立血清肌钙蛋白-I（cTnI）均相免疫检测方法。方法：使用兔抗人cTnI多克隆抗体包被受体微球，羊抗人cTnI单克隆抗体进行生物素化与链霉亲和素包被的供体微球共同构成检测试剂，优化反应条件并进行方法学评价。结果：本方法快速、敏感，检测时间为17．5 min；分析灵敏度为0．045 ng/mL，功能灵敏度为0．053 ng/mL；回收率为104．96％～108．21％；批内精密度为3．88％～5．53％，批间精密度为7．60％～8．75％；特异性分析中各种内源性物质的干扰率均＜10％；本方法测得的cTnI正常参考值上限为1．05 ng/mL。与直接化学发光检测法具有良好的相关性（r2＝0．979）。结论：本研究建立的方法能够用于定量检测血清cTnI，该方法具有均相、免清洗分离等优点，为临床提供了一个便捷高敏的检测平台。
목적：채용광격화학발광면역분석기술건립혈청기개단백-I（cTnI）균상면역검측방법。방법：사용토항인cTnI다극륭항체포피수체미구，양항인cTnI단극륭항체진행생물소화여련매친화소포피적공체미구공동구성검측시제，우화반응조건병진행방법학평개。결과：본방법쾌속、민감，검측시간위17．5 min；분석령민도위0．045 ng/mL，공능령민도위0．053 ng/mL；회수솔위104．96％～108．21％；비내정밀도위3．88％～5．53％，비간정밀도위7．60％～8．75％；특이성분석중각충내원성물질적간우솔균＜10％；본방법측득적cTnI정상삼고치상한위1．05 ng/mL。여직접화학발광검측법구유량호적상관성（r2＝0．979）。결론：본연구건립적방법능구용우정량검측혈청cTnI，해방법구유균상、면청세분리등우점，위림상제공료일개편첩고민적검측평태。
Objective To establish homogeneous immunoassay for detecting serum cardiac troponin I (cTnI) by using light induced chemiluminescent immunoassay (LiCA). Methods Polyclonal antibodies of cTnI were coated on the receptor particles, monoclonal antibodies of cTnI were biotinylated, and the donor particles were coated with streptavidin, all of which were composed of LiCA reagents. The optimal test conditions and analytical performance of the detection method were studied. Results The method was rapid, sensitive, and detection time was 17.5 min.The analytical sensitivity was 0.045 ng/mL and the functional sensitivity was 0.053 ng/mL.The recovery rate was 104.96%-108.21%;The within-run and the between-run coefficients of variation were 3.88%-5.53%and 7.60%-8.75%, respectively. The interference rates for the endogenous substances were less than 10%. The reference value of cTnI was less than 1.05 ng/mL;Results of cTnI LiCA correlated well with direct chemiluminescence detection (r2 =0.979). Conclusions This approach can be used for the quantitative detection of serum cTnI, and it is homogeneous and is free of clean separation. It provides a convenient, highly sensitive detection platform for clinical practice.