Hmaïed F, Ben Mamou M, Arrouji Z, Slim A, Ben Redjeb S
Laboratoire de microbiologie, hôpital Charles-Nicolle, 1006 Tunis, Tunisie.
Pathol Biol (Paris). 2007 Mar;55(2):121-6. doi: 10.1016/j.patbio.2006.02.005. Epub 2006 May 2.
In this study, we aimed at evaluating the performances of a combined assay for the detection of hepatitis C virus core antigen and antibodies and comparing this test with conventional third generation Elisa.
Two hundred forty-one samples were included in this study and tested by Monolisa HCV Ag-Ab ULTRA, Biorad and compared to Monolisa Anti-HCV Plus. A comparative study was performed on a HCV seroconversion panel (Monolisa anti-HCV Plus, Biorad; Innotest HCV Ab IV, Innogenetics and Murex anti-HCV, Abbott). False positive samples were detected with western blot assay (INNO-LIA HCV Ab III, Innogenetics). Two anti-HCV negative haemodialysis patients with rise in ALT have been tested for RNA detection (Amplicor v2.0, Roche).
Results obtained with Biorad Ag-Ab were in agreement with third generation ELISA on HCV seroconversion panel. From anti-HCV negative patients, four samples were found low positive with HCV Ag-Ab. Two anti-HCV negative haemodialysis patients/HCV RNA positive were also negative with HCV Ag-Ab and 13 low positive samples with Biorad Ab were found negative with Ag-Ab.
The HCV Ag-Ab assay has a high specificity and sensitivity comparatively to conventional ELISA; but in our study we don't prove the reduction of the "serologic window" for detection of anti-HCV antibodies.
在本研究中,我们旨在评估一种用于检测丙型肝炎病毒核心抗原和抗体的联合检测方法的性能,并将该检测与传统第三代酶联免疫吸附测定(ELISA)进行比较。
本研究纳入了241份样本,采用伯乐公司的Monolisa HCV Ag-Ab ULTRA进行检测,并与Monolisa Anti-HCV Plus进行比较。对一个丙型肝炎病毒血清转化样本组(伯乐公司的Monolisa anti-HCV Plus;英诺基因公司的Innotest HCV Ab IV;雅培公司的Murex anti-HCV)进行了一项对比研究。采用免疫印迹法(英诺基因公司的INNO-LIA HCV Ab III)检测假阳性样本。对两名抗-HCV阴性且谷丙转氨酶(ALT)升高的血液透析患者进行了RNA检测(罗氏公司的Amplicor v2.0)。
在丙型肝炎病毒血清转化样本组中,伯乐公司的Ag-Ab检测结果与第三代ELISA一致。在抗-HCV阴性患者中,有4份样本经HCV Ag-Ab检测呈低阳性。两名抗-HCV阴性的血液透析患者/HCV RNA阳性,其HCV Ag-Ab检测结果也为阴性,并且发现伯乐公司的Ab检测呈低阳性的13份样本经Ag-Ab检测为阴性。
与传统ELISA相比,HCV Ag-Ab检测具有较高的特异性和敏感性;但在我们的研究中,未证实检测抗-HCV抗体的“血清学窗口期”有所缩短。