Odari E O, Budambula N L M, Nitschko H
Max von Pettenkofer Institute for Hygiene and Medical Microbiology - LMU, Munich, Germany ; Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.
Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.
Ethiop J Health Sci. 2014 Oct;24(4):343-52. doi: 10.4314/ejhs.v24i4.10.
Development of "combination" assays detecting in parallel, within a single test, Hepatitis C Virus (HCV) antigens and antibodies, not only reduces the window period in HCV-infection but also costs. Reduction of costs is important for developing countries where money and personal resources are limited.
We compared the Monolisa® HCV Antigen-Antibody Ultra (Bio-Rad Laboratories Limited, Marnes La Coquette, France) with the AXSYM HCV version 3.0 (Abbot Diagnostics, Germany)-the latter assay detecting only antibodies to HCV. Seventy three HCV-PCR positive and negative samples were tested.
Although the two assays showed comparable results, two samples from a bone marrow transplant (BMT) patient of viral loads 7.8 × 105 and 8.9 × 106 IU/mL could not be detected by the Monolisa® HCV Antigen-Antibody Ultra assay. Failure to detect the two samples with viral loads considered above threshold of detection for antigen proteins suggested a lack of sensitivity by this assay to discover viral capsid protein in patient samples. Genotyping of these samples revealed genotype 1b, a HCV-subtype which is widespread and should thus be easily detected.
We conclude that although this assay depicts high sensitivity and specificity in detecting antibodies to HCV, it seems not to add further benefit in our study population to detect HCV infections by enhanced sensitivity due the potential contingency to trace viral capsid antigens.
“联合”检测法能够在单次检测中同时并行检测丙型肝炎病毒（HCV）抗原和抗体，这不仅缩短了HCV感染的窗口期，还降低了成本。对于资金和个人资源有限的发展中国家而言，降低成本至关重要。
我们将Monolisa® HCV抗原-抗体超敏检测法（法国马恩拉科凯特市伯乐生命医学产品有限公司）与AXSYM HCV 3.0版本检测法（德国雅培诊断公司）进行了比较，后者仅检测HCV抗体。对73份HCV-PCR阳性和阴性样本进行了检测。
尽管两种检测方法的结果相当，但来自一名骨髓移植（BMT）患者的两份病毒载量分别为7.8×10⁵和8.9×10⁶ IU/mL的样本无法被Monolisa® HCV抗原-抗体超敏检测法检测到。由于上述病毒载量高于抗原蛋白的检测阈值却未能检测到这两份样本，表明该检测法在检测患者样本中的病毒衣壳蛋白时缺乏敏感性。对这些样本进行基因分型显示为1b型，这是一种广泛传播的HCV亚型，因此应该很容易被检测到。
我们得出结论，尽管该检测法在检测HCV抗体时表现出高敏感性和特异性，但在我们的研究人群中，由于追踪病毒衣壳抗原存在潜在的偶然性，通过提高敏感性来检测HCV感染似乎并没有带来更多益处。
