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目的通过追踪分析化学发光在低风险人群HCV感染确证中的应用。方法收集102例ELISA1抗-HCV反应性献血者及5例追踪血液样本、100例多次献血者阴性对照样本,补充另一种酶联免疫吸附试验(ELISA2)、重组免疫印迹试验(WB)、化学发光试验(CMIA)和HCV RNA定性检测,分析CMIA检测结果与HCV感染确证的关联。结果以ELISA2及WB法检测结果为参考标准,CMIA与参考标准结果高度相关(Spearman相关系数rs=0.866,P<0.01),Kappa检验两者一致性极强(Kappa=0.857,P<0.01)。追踪5例CMIA与参考标准不一致样本,5例ELISA2、WB、HCV RNA均为阴性,2例CMIA阳性,3例ELISA1阳性。结论 CMIA可以较好检出低风险人群确证HCV感染样本,但也存在一些假阳性。
Objective To investigate the application of chemiluminescence in the confirmation of HCV infection in low-risk population by tracing. Methods A total of 102 ELISA1 anti-HCV reactive blood donors and 5 follow-up blood samples were collected. 100 negative control blood samples from multiple blood donors were collected and supplemented with another enzyme-linked immunosorbent assay (ELISA), Western blotting (WB) Chemiluminescence assay (CMIA) and HCV RNA qualitative detection, analysis of CMIA test results and HCV infection confirmed the association. The results of ELISA and WB test results as a reference standard, CMIA highly correlated with the reference standard results (Spearman correlation coefficient rs = 0.866, P <0.01), Kappa test the consistency between the two (Kappa = 0.857, P <0.01). Five cases of inconsistent CMIA and reference standards were followed up. Five cases of ELISA2, WB and HCV RNA were negative, two cases of CMIA positive and three cases ELISA1 positive. Conclusion CMIA can detect low-risk populations confirmed HCV infection samples, but there are also some false positives.