Vrielink H, van der Poel C L, Reesink H W, Lelie P N
Rode Kruis Bloedbank Amsterdam, The Netherlands.
Infusionsther Transfusionsmed. 1995 Jun;22(3):164-7. doi: 10.1159/000223117.
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.
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).
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.
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.
本研究的目的是比较两种抗丙型肝炎病毒（HCV）酶联免疫吸附测定（ELISA）检测丙型肝炎抗原时的敏感性和特异性。
将第三代抗HCV ELISA（Wellcozyme抗HCV VK45）与第二代抗HCV ELISA（Ortho HCV 2.0）在不同血清样本组中进行比较：A）献血者中抗HCV ELISA阳性样本（n = 536），B）非甲非乙型肝炎患者（n = 188），C）多次输血患者（n = 79），D）血液透析患者（n = 473），以及E）随机献血者（n = 1080）。
在A、B和C组的248个经互补脱氧核糖核酸聚合酶链反应（cDNA-PCR）检测呈阳性的样本中，ELISA-VK45检测出247个（99.6%），Ortho-2检测出248个（100%）。ELISA-VK45漏检的cDNA-PCR阳性样本在第二代重组免疫印迹法（RIBA-2）中显示出单独的抗C33c反应性。在281个RIBA-2阳性样本中，ELISA-VK45检测出274个（97.5%），Ortho-2检测出279个（99.3%）。ELISA-VK45阴性、RIBA-2阳性的样本在7个病例中有6个在RIBA-2中显示出抗C100/5-1-1联合反应性，1个显示出抗C22和C33c反应性。Ortho-2阴性、RIBA-2阳性的样本在2个病例中均在RIBA-2中显示出抗C100/5-1-1联合反应性。在1080名献血者中，ELISA-VK45和Ortho-2的特异性无显著差异。
得出结论，ELISA-VK45缺乏敏感性，因为该检测中漏检了一个经cDNA-PCR确认的阳性样本。两种ELISA的特异性相当。
