Pawlotsky J M, Bastie A, Pellet C, Remire J, Darthuy F, Wolfe L, Sayada C, Duval J, Dhumeaux D
Department of Bacteriology and Virology, Hôpital Henri Mondor, Université Paris XII, Créteil, France.
J Clin Microbiol. 1996 Jan;34(1):80-3. doi: 10.1128/jcm.34.1.80-83.1996.
Indeterminate hepatitis C virus (HCV) third-generation recombinant immunoblot assay (RIBA3.0; Ortho Diagnostic Systems) patterns were arbitrarily defined by the manufacturer as the detection of only one antibody out of the four that were sought, namely, c100 (NS4 encoded), c22 (core encoded), c33c (NS3 encoded), and NS5 (NS5 encoded). The aims of the present study were (i) to determine the prevalence of indeterminate RIBA3.0 patterns in patients consecutively tested for anti-HCV antibodies in a university hospital; (ii) to evaluate the significance of these patterns in terms of viral replication, liver disease, and risk factors for HCV; and (iii) to get an insight into the mechanism underlying this peculiar immune response. Among 3,074 serum samples consecutively tested for anti-HCV antibodies, 588 were found to be positive by screening assays. Fifty-nine of them (10%) were RIBA3.0 indeterminate and were compared with 59 RIBA3.0-positive ones. Thirty-one RIBA3.0-indeterminate and 53 RIBA3.0-positive serum samples were HCV RNA positive by PCR (53 versus 90%; P < 10(-6). RIBA3.0-indeterminate and RIBA-3.0-positive patients with positive PCR results were not significantly different for the prevalence of risk factors for HCV infection and elevated serum alanine aminotransferase activities. Immunosuppression, attributable to coexisting human immunodeficiency virus infection, organ transplantation, or the administration of immunosuppressive drugs, was significantly more frequent in PCR-positive, RIBA3.0-indeterminate patients than in PCR-negative, RIBA3.0 indeterminate patients (P < 0.001) and PCR-positive patients with a positive RIBA3.0 result (P < 0.01). The distribution of HCV genotypes did not differ significantly between HCV RNA-positive patients with indeterminate or positive RIBA3.0 results. In conclusion, the prevalence of indeterminate RIBA3.0 patterns in virology laboratories is about 10%; in about half of these patients HCV replication is detected by PCR; the main factor responsible for indeterminate RIBA3.0 patterns could be immunosuppression, whereas HCV genotypes do not seem to play major role.
丙型肝炎病毒（HCV）第三代重组免疫印迹法（RIBA3.0；奥索诊断系统公司）的不确定结果模式由制造商任意定义为仅检测到所检测的四种抗体中的一种，即c100（由NS4编码）、c22（由核心编码）、c33c（由NS3编码）和NS5（由NS5编码）。本研究的目的是：（i）确定在一家大学医院连续接受抗HCV抗体检测的患者中RIBA3.0不确定结果模式的发生率；（ii）从病毒复制、肝脏疾病和HCV危险因素方面评估这些结果模式的意义；（iii）深入了解这种特殊免疫反应的潜在机制。在连续接受抗HCV抗体检测的3074份血清样本中，588份通过筛查检测呈阳性。其中59份（10%）RIBA3.0结果不确定，并与59份RIBA3.0结果阳性的样本进行比较。31份RIBA3.0结果不确定和53份RIBA3.0结果阳性的血清样本经PCR检测HCV RNA呈阳性（53%对90%；P<10⁻⁶）。RIBA3.0结果不确定和RIBA3.0结果阳性且PCR结果为阳性的患者在HCV感染危险因素的发生率和血清丙氨酸转氨酶活性升高方面无显著差异。在PCR结果阳性、RIBA3.0结果不确定的患者中，因同时感染人类免疫缺陷病毒、进行器官移植或使用免疫抑制药物导致的免疫抑制明显比PCR结果阴性、RIBA3.0结果不确定的患者（P<0.001）以及RIBA3.0结果阳性且PCR结果为阳性的患者（P<0.01）更为常见。HCV RNA结果不确定或阳性的患者中，HCV基因型的分布无显著差异。总之，病毒学实验室中RIBA3.0结果不确定模式的发生率约为10%；在这些患者中约一半通过PCR检测到HCV复制；导致RIBA3.0结果不确定的主要因素可能是免疫抑制，而HCV基因型似乎不起主要作用。
