Yuen M F, Hui C K, Yuen J C, Young J L, Lai C L
Department of Medicine, The University of Hong Kong, Queen Mary Hospital, China.
Am J Gastroenterol. 2001 Mar;96(3):838-41. doi: 10.1111/j.1572-0241.2001.03628.x.
Conventional tests for antibody to hepatitis C virus (HCV) require considerable time before results are available. The aim of this study is to examine the accuracy of a new quick test (SM-HCV Rapid Test) for the detection of antibody to hepatitis C virus with reference to the well-established third generation enzyme immunoblot assay (EIA-3; Abbott Laboratories, Chicago, IL).
A total of 290 subjects (100 patients with chronic hepatitis C infections, 95 patients with other chronic liver diseases, 95 healthy subjects) were recruited. Thirty microliters of serum was tested for anti-HCV by SM-HCV Rapid Test according to the manufacturer's instruction. Liver function tests and serum HCV RNA by polymerase chain reaction (PCR) were measured.
In the 100 patients positive for anti-HCV by EIA-3, 98 of these patients were also positive for anti-HCV by SM-HCV Rapid Test. In the 95 patients with other chronic liver diseases, 94 samples were negative for anti-HCV by both EIA-3 and SM-HCV Rapid Test. The remaining one patient was positive for anti-HCV by the EIA-3 but negative by the SM-HCV Rapid Test. In the 95 controls, which were negative for anti-HCV by EIA-3, all were also negative for anti-HCV by SM-HCV Rapid Test and HCV RNA by PCR. Using EIA-3 as the gold standard screening test for anti-HCV, the sensitivity and the specificity of SM-HCV Rapid Test were 98% and 100%, respectively. The positive predictive value and negative predictive value of SM-HCV Rapid Test were 100% and 97.9%, respectively.
SM-HCV Rapid Test is a reliable test with high sensitivity and specificity. The anti-HCV result can be available within a very short period of time. It is a useful screening test for anti-HCV.
丙型肝炎病毒（HCV）抗体的传统检测方法在获得结果前需要相当长的时间。本研究旨在参照成熟的第三代酶免疫印迹法（EIA-3；雅培实验室，伊利诺伊州芝加哥），检验一种新型快速检测方法（SM-HCV快速检测）检测丙型肝炎病毒抗体的准确性。
共招募了290名受试者（100例慢性丙型肝炎感染患者、95例其他慢性肝病患者、95名健康受试者）。按照制造商的说明，用SM-HCV快速检测法检测30微升血清中的抗HCV。检测肝功能以及通过聚合酶链反应（PCR）检测血清HCV RNA。
在100例EIA-3检测抗HCV呈阳性的患者中，98例患者的SM-HCV快速检测抗HCV也呈阳性。在95例其他慢性肝病患者中，94份样本的EIA-3和SM-HCV快速检测抗HCV均为阴性。其余1例患者EIA-3检测抗HCV呈阳性，但SM-HCV快速检测呈阴性。在95例EIA-3检测抗HCV呈阴性的对照者中，所有对照者的SM-HCV快速检测抗HCV以及PCR检测HCV RNA均为阴性。以EIA-3作为抗HCV的金标准筛查试验，SM-HCV快速检测的灵敏度和特异性分别为98%和100%。SM-HCV快速检测的阳性预测值和阴性预测值分别为100%和97.9%。
SM-HCV快速检测是一种可靠的检测方法，具有高灵敏度和特异性。抗HCV结果可在很短时间内获得。它是一种有用的抗HCV筛查试验。
