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目的评价国产丙型肝炎病毒抗体重组免疫印迹(HCV RIBA)试剂在检测anti-HCV阳性献血者中应用价值。方法采用国产RIBA试剂对107例进口酶联免疫吸附试验(ELISA)检出的抗-HCV阳性样本进行补充实验。平行HBV/HCV/HIV三联单样本核酸定性检测HCV RNA,对RIBA试剂性能进行评价。结果 RIBA阳性检出率50.47%(54/107),RIBA阳性样本中HCV RNA检出率为59.26%(32/54)。随着RIBA结果中条带数增加,HCV RNA检出率增加。RIBA试剂NS3抗原条带检出率最高(90.91%),33例HCV RNA阳性样本NS3均为阳性,阳性符合率100%,两者中等相关性(Spearman相关系数rs=0.486,P<0.01),52.85%NS3阳性样本未检测出HCV RNA(37/70),结果一致性较差(Kappa=0.382,P<0.001)。22例RIBA阳性/HCV RNA无反应性样本中2例HCV RNA定量检测阳性,另一进口抗-HCV酶免检测试验结果阳性。结论国产RIBA试剂作为检测献血者HCV感染补充实验具有一定应用价值。RIBA可疑结果可以检出部分极低载量HCV RNA样本。
Objective To evaluate the value of HCV RIBA reagent in the detection of anti-HCV positive blood donors. Methods A total of 107 anti-HCV positive samples detected by enzyme-linked immunosorbent assay (ELISA) were supplemented with domestic RIBA reagents. The parallel HBV / HCV / HIV triplex sample nucleic acids were used to qualitatively detect HCV RNA to evaluate the RIBA reagent performance. Results The positive rate of RIBA was 50.47% (54/107). The positive rate of HCV RNA in RIBA positive samples was 59.26% (32/54). As the number of bands in the RIBA results increases, the detection rate of HCV RNA increases. The positive rate of NS3 in RIBA reagent was 90.91%, and the positive rate of NS3 in all 33 HCV RNA samples was 100% (Spearman correlation coefficient rs = 0.486, P <0.01) HCV RNA (37/70) was undetectable in 52.85% of NS3-positive samples and the results were poorly consistent (Kappa = 0.382, P <0.001). Of the 22 RIBA-positive / HCV RNA-non-responsive samples, 2 were positive for HCV RNA, and the other was positive for anti-HCV enzyme-free test. Conclusion The domestic RIBA reagent has certain value as a supplementary test for detecting HCV infection in blood donors. RIBA suspicious results can detect some very low-load HCV RNA samples.