ELISA试剂检测抗HCV反应性结果分析

目的探讨丙型肝炎病毒抗体(抗HCV)进口酶联免疫吸附试验(ELISA)试剂在血液筛查中的效果及与国产试剂、重组免疫印迹试验(RIBA)确证检测的相关性。方法用RIBA确证试剂及国内销量前2名的国产抗HCV ELISA试剂对56例进口抗HCV ELISA试剂检测呈反应性的标本进行检测分析。结果 56例标本经RIBA确证结果为阳性12例,不确定18例,阴性26例。3种试剂均为反应性的9例标本中,确证阳性7例,不确定1例,阴性1例。结论目前市售的丙型肝炎ELISA试剂均存在较大的生物学假阳性,不同试剂间检测结果仍存在一定差异。为确保输血安全,建议有条件的采供血机构实验室抗HCV检测时以国产和进口试剂联合检测为佳。

Result analysis on anti-HCV reaction determination by ELISA reagents

Objective To evaluate the efficiency of imported anti-hepatitis C virus （HCV） enzyme-linked immunosorbent assay （ELISA） reagent in blood screening test and analyze the correlations among imported ELISA reagent, domestic ELISA reagent and recombinant immunoblot assay（RIBA）. Methods A total of 56 anti-HCV positive specimens tested by imported ELISA reagent were retested by 2 domestic ELISA reagents, and the confirmatory test RIBA was also carried out. Results Among 56 positive specimens with imported anti-HCV ELISA reagent, the confirmatory test RIBA showed that the 12 specimens were confirmed to be positive , 18 specimens were indeterminate and 26 specimens were negative. Of the 9 specimens which were positive with 3 ELISA reagents, 7 specimens were confirmed to be positive, 1 specimen was indeterminate and 1 specimen was negative. Conclusions The false positivity with anti-HCV ELISA reagent is obvious, and there would be some different results with different anti-HCV ELISA reagents. For ensuring the blood safety, the imported ELISA reagent and the domestic ELISA reagent should be used simultaneously in anti-HCV screening test.