de Medina M, Hill M, Sullivan H O, Leclerq B, Pennell J P, Jeffers L, Reddy K R, Schiff E R, Perez G O
Division of Hepatology and Nephrology, University of Miami School of Medicine, and the Veterans Administration Medical Center, Florida 33125, USA.
J Lab Clin Med. 1998 Jul;132(1):73-5. doi: 10.1016/s0022-2143(98)90028-2.
Hepatitis C virus (HCV) infection is endemic in long-term dialysis units. We assessed the performance of a recently developed HCV 3.0 assay for the detection of HCV antibodies in patients undergoing dialysis. The study evaluated 128 patients undergoing long-term maintenance hemodialysis. Anti-HCV was detected by 2.0 and 3.0 enzyme immunoassay (EIA). Results were confirmed with recombinant immunoblot assays (RIBA 2.0 and RIBA 3.0). HCV RNA was detected by using reverse transcriptase-polymerase chain reaction (RT-PCR). Thirty-two patients (25%) were HCV EIA 2.0 positive. Of these, 1 was RIBA 2.0 negative (PCR positive), 3 were indeterminate (3 PCR positive), and 28 were positive (23 PCR positive). Thirty-five (27%) were HCV EIA 3.0 positive. One was RIBA 3.0 negative (PCR positive), 1 was indeterminate (c33c, PCR positive), and 33 were positive (27 PCR positive) by RIBA 3.0. Thus only 1 PCR-positive patient was negative with RIBA 2.0 and 3.0 assays. Two of the 3 RIBA 2.0 indeterminate samples were positive with RIBA 3.0. One remained indeterminate but was HCV RNA positive. In summary, HCV 3.0 EIA detected 4 additional viremic patients but was positive in 6 PCR-negative subjects. A high correlation of the presence of antibody to c33c with HCV RNA (28 of 34, 82%) was found, and it was found in all anti-HCV positive samples and in 1 indeterminate sample. We conclude that the HCV EIA 3.0 test with the supplemental confirmatory RIBA 3.0 test may improve the sensitivity for the detection of anti-HCV. Nevertheless, in potentially immunocompromised patients undergoing dialysis, PCR continues to be the only reliable test for detecting viremia.
丙型肝炎病毒（HCV）感染在长期透析单位中呈地方性流行。我们评估了一种最近开发的HCV 3.0检测方法在检测透析患者HCV抗体方面的性能。该研究评估了128例接受长期维持性血液透析的患者。通过2.0和3.0酶免疫测定（EIA）检测抗HCV。结果用重组免疫印迹测定（RIBA 2.0和RIBA 3.0）进行确认。使用逆转录-聚合酶链反应（RT-PCR）检测HCV RNA。32例患者（25%）HCV EIA 2.0呈阳性。其中，1例RIBA 2.0阴性（PCR阳性），3例结果不确定（3例PCR阳性），28例阳性（23例PCR阳性）。35例（27%）HCV EIA 3.0呈阳性。1例RIBA 3.0阴性（PCR阳性），1例结果不确定（c33c，PCR阳性），33例RIBA 3.0呈阳性（27例PCR阳性）。因此，只有1例PCR阳性患者RIBA 2.0和3.0检测呈阴性。3例RIBA 2.0结果不确定的样本中有2例RIBA 3.0呈阳性。1例仍结果不确定但HCV RNA呈阳性。总之，HCV 3.0 EIA检测出另外4例病毒血症患者，但在6例PCR阴性受试者中呈阳性。发现抗c33c抗体的存在与HCV RNA高度相关（34例中的28例，82%），并且在所有抗HCV阳性样本和1例结果不确定的样本中均有发现。我们得出结论，HCV EIA 3.0检测结合补充性确证RIBA 3.0检测可能会提高抗HCV检测的灵敏度。然而，对于接受透析的潜在免疫功能低下患者，PCR仍然是检测病毒血症的唯一可靠检测方法。
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