Vrielink H, Zaaijer H L, Reesink H W, Lelie P N, van der Poel C L
Red Cross Blood Bank Amsterdam, The Netherlands.
Transfusion. 1995 Jul;35(7):601-4. doi: 10.1046/j.1537-2995.1995.35795357885.x.
Third-generation anti-hepatitis C virus (HCV) enzyme-linked immunosorbent assays (ELISA) are now implemented in most laboratories in Europe, but have not yet been fully implemented in the United States.
Two ELISAs (Ortho 3.0 and Ortho 2.0, Ortho Diagnostics, Raritan, NJ) were compared by tests on various serum panels: A) blood donor samples (n = 530) that tested positive in first- or second-generation anti-HCV ELISA; B) samples from persons with chronic non-A, non-B hepatitis (n = 185); C) samples from multiply transfused patients (n = 79); D) samples from patients on hemodialysis (n = 473); and E) samples from Dutch random blood donors (n = 2153).
In panels A, B, and C, 247 (100%) of 247 polymerase chain reaction (PCR)-positive and 278 (100%) of 278 second-generation recombinant immunoblot assay (RIBA-2)-positive specimens were detected by Ortho 2.0 and 3.0 (sensitivity, 100%). In the sera of panel D, used to represent a group of patients with a high risk for HCV, no additional positives were found by Ortho 3.0. In panel E, of 2153 blood donor samples, 2 (0.1%) were positive in Ortho 2.0 and 8 (0.4%) in Ortho 3.0. Two samples that were positive in both Ortho 2.0 and 3.0 were also positive in RIBA-2; one was positive on PCR. From the 6 remaining Ortho 3.0-positive (Ortho 2.0-negative) samples, 1 was positive in RIBA-2 (isolated anti-c100) and 3 were positive in third-generation RIBA (1/3 isolated anti-c100, 2/3 isolated NS5). All 6 samples were PCR negative. In first-time donors, no difference in specificity was found.
The sensitivity and specificity of the Ortho 3.0 ELISA are comparable to those of the Ortho 2.0 ELISA.
第三代抗丙型肝炎病毒（HCV）酶联免疫吸附测定（ELISA）目前已在欧洲的大多数实验室中采用，但在美国尚未完全普及。
通过对各种血清样本进行检测，比较了两种ELISA（Ortho 3.0和Ortho 2.0，Ortho诊断公司，拉里坦，新泽西州）：A）在第一代或第二代抗HCV ELISA中检测呈阳性的献血者样本（n = 530）；B）慢性非甲非乙型肝炎患者的样本（n = 185）；C）多次输血患者的样本（n = 79）；D）血液透析患者的样本（n = 473）；以及E）荷兰随机献血者的样本（n = 2153）。
在A、B和C组样本中，Ortho 2.0和3.0检测出247份聚合酶链反应（PCR）阳性样本中的247份（100%）以及278份第二代重组免疫印迹试验（RIBA-2）阳性样本中的278份（100%）（灵敏度为100%）。在用于代表HCV高风险患者群体的D组血清中，Ortho 3.0未发现额外的阳性样本。在E组的2153份献血者样本中，Ortho 2.0检测出2份（0.1%）呈阳性，Ortho 3.0检测出8份（0.4%）呈阳性。在Ortho 2.0和3.0中均呈阳性的两份样本在RIBA-2中也呈阳性；其中一份在PCR检测中呈阳性。在其余6份Ortho 3.0阳性（Ortho 2.0阴性）样本中，1份在RIBA-2中呈阳性（孤立的抗c100），3份在第三代RIBA中呈阳性（1/3为孤立的抗c100，2/3为孤立的NS5）。所有6份样本的PCR检测均为阴性。在首次献血者中，未发现特异性存在差异。
Ortho 3.0 ELISA的灵敏度和特异性与Ortho 2.0 ELISA相当。
