Comparison of two anti-hepatitis C virus enzyme-linked immunosorbent assays: Wellcozyme VK45 and Ortho 2.0.

Infusionstherapie und Transfusionsmedizin Pub Date : 1995-06-01 DOI:10.1159/000223117

H Vrielink, C L van der Poel, H W Reesink, P N Lelie

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引用次数: 1

Abstract

Background: The aim of the present study was to compare 2 anti-HCV ELISA tests with respect to sensitivity and specificity in detecting Hepatitis C antigen.

Materials and methods: A 3rd-generation anti-HCV ELISA (Wellcozyme anti-HCV VK45) was compared with a 2nd-generation anti-HCV ELISA (Ortho HCV 2.0) in various serum panels: A) anti-HCV ELISA-positive samples of blood donations (n = 536), B) non-A, non-B hepatitis patients (n = 188), C) multi-transfused patients (n = 79), D) hemodialysis patients (n = 473), and E) random blood donors (n = 1,080).

Results: Of 248 cDNA polymerase chain reaction (cDNA-PCR) positive samples in panels A, B, and C, ELISA-VK45 detected 247 (99.6%) and Ortho-2 248 (100%). The cDNA-PCR-positive sample missed by ELISA-VK45 showed isolated anti-C33c reactivity in a 2nd-generation recombinant immunoblot (RIBA-2). Of 281 RIBA-2-positive samples, ELISA-VK45 detected 274 (97.5%) and Ortho-2 279 (99.3%). ELISA-VK45-negative, RIBA-2-positive samples showed combined anti-C100/5-1-1 reactivity in RIBA-2 in 6/7 cases and anti-C22 and C33c reactivity in one. Ortho-2-negative, RIBA-2-positive samples showed combined anti-C100/5-1-1 reactivity in RIBA-2 in 2/2 cases. The specificities of ELISA-VK45 and Ortho-2 were not significantly different in 1,080 blood donors.

Conclusion: It is concluded that the ELISA-VK45 lacks sensitivity because a cDNA-PCR-confirmed positive sample was missed in the assay. The specificity of both ELISAs was comparable.

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两种抗丙型肝炎病毒酶联免疫吸附试验的比较:Wellcozyme VK45和Ortho 2.0。

背景:本研究的目的是比较两种抗hcv ELISA检测在检测丙型肝炎抗原方面的敏感性和特异性。材料与方法:将第三代抗-HCV ELISA (Wellcozyme anti-HCV VK45)与第二代抗-HCV ELISA (Ortho HCV 2.0)在不同血清组进行比较:A)抗-HCV ELISA阳性献血者(n = 536)， B)非A、非B型肝炎患者(n = 188)， C)多次输血患者(n = 79)， D)血液透析患者(n = 473)， E)随机献血者(n = 1080)。结果:A、B、C三组248份cDNA聚合酶链反应(cDNA- pcr)阳性样本中，ELISA-VK45检测到247份(99.6%)，检测到orth2 248份(100%)。ELISA-VK45缺失的cdna - pcr阳性样品在第二代重组免疫印迹(RIBA-2)中显示出分离的抗c33c反应性。在281份riba -2阳性样本中，ELISA-VK45检测到274份(97.5%)，orth2 279份(99.3%)。elisa - vk45阴性、RIBA-2阳性样品中6/7的RIBA-2具有抗c100 /5-1-1反应性，1例的RIBA-2具有抗c22和C33c反应性。在2/2的病例中，ortho -2阴性和RIBA-2阳性样品显示出抗c100 /5-1-1的联合反应性。在1080名献血者中，ELISA-VK45和orth2的特异性无显著差异。结论:ELISA-VK45缺乏敏感性，因为在检测中遗漏了一个cdna - pcr确认的阳性样本。两种elisa的特异性具有可比性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Infusionstherapie und Transfusionsmedizin

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