Dussaix E, Charnaux N, Laurent-Puig P, Chopineau S, Laurian Y, Buffet C
Department of Virology, Hôpital de Bicêtre, Le Kremlin-Bicêtre, France.
J Clin Microbiol. 1994 Sep;32(9):2071-5. doi: 10.1128/jcm.32.9.2071-2075.1994.
The diagnostic performances of three commercially available recombinant immunoblot assays (RIBAs) for anti-hepatitis C virus antibody were evaluated on 50 ORTHO-HCV RIBA-2 (RIBA-2)-indeterminate serum samples. Concordant interpretations were obtained with the three tests in 60% of the samples, with 56% positive, 2% indeterminate, and 2% negative results. Considering test performance in regard to the number of remaining indeterminate results, analyzing sera by RIBA-3, INNO-LIA HCV Ab III, and DECISCAN HCV reduced the number of samples reacting indeterminately to 40, 6, and 8%, respectively. The three serum samples classified as indeterminate in the INNO-LIA HCV Ab III as well as three of four serum samples interpreted as indeterminate in the DECISCAN HCV and 16 of 20 samples classified as indeterminate in the RIBA-3 were hepatitis C virus RNA positive by PCR. This study clearly shows the good performance of the three tests as confirmatory assays compared with that of the RIBA-2. However, according to the manufacturers' criteria of positivity, the INNO-LIA HCV Ab III and DECISCAN HCV appeared to be more suitable than the RIBA-3 for interpreting serum samples found indeterminate in the RIBA-2.
在50份ORTHO - HCV RIBA - 2（RIBA - 2）结果不确定的血清样本上评估了三种市售重组免疫印迹法（RIBAs）检测抗丙型肝炎病毒抗体的诊断性能。在60%的样本中，三种检测方法得出了一致的结果，其中56%为阳性，2%为不确定，2%为阴性。就剩余不确定结果的数量而言，考虑检测性能，用RIBA - 3、INNO - LIA HCV Ab III和DECISCAN HCV分析血清后，反应不确定的样本数量分别减少至40%、6%和8%。在INNO - LIA HCV Ab III中分类为不确定的三份血清样本，以及在DECISCAN HCV中解释为不确定的四份血清样本中的三份，还有在RIBA - 3中分类为不确定的20份样本中的16份，经PCR检测丙型肝炎病毒RNA呈阳性。本研究清楚地表明，与RIBA - 2相比，这三种检测方法作为确证试验具有良好的性能。然而，根据制造商的阳性标准，对于解释在RIBA - 2中发现的不确定血清样本，INNO - LIA HCV Ab III和DECISCAN HCV似乎比RIBA - 3更合适。
