J Viral Hepat. 2013 Apr;20(4):290-3. doi: 10.1111/jvh.12002. Epub 2012 Aug 27.
Rapid testing for HCV has become a routine practice in resource-limited settings for initial screening. The objective of this study was to evaluate the performance of rapid immunoassay diagnostic test kits for specific and accurate diagnosis of HCV infection among different patient groups in clinical settings of Kolkata, India. Two hundred and fifty-four randomly selected serum samples of 612 samples reported as HCV nonreactive by rapid immunodiagnostic tests were evaluated for HCV antibody, ELISA and HCV RNA testing for confirmatory diagnosis. 15.74% were HCV seropositive by ELISA, and 11.02% were RNA positive by nested RT-PCR. Additionally, 15 HCV-seronegative chronic liver disease patients with high ALT and AST values were screened for HCV RNA, of which five were positive whose viral load ranged from 1.2 × 10(2) to 4.4 × 10(6) IU/mL, and the samples belonged to IVDUs and HIV-co-infected individuals. The results showed that HCV rapid immunoassay test cannot be solely relied on as an absolute and accurate diagnostic tool for screening infection of HCV particularly in high-risk group patients such as IVDUs, haemodialysis, thalassaemic and HIV-co-infected patients who need HCV screening frequently.
在资源有限的环境中，快速检测 HCV 已成为初始筛选的常规做法。本研究的目的是评估快速免疫诊断试剂盒在印度加尔各答临床环境中不同患者群体中对 HCV 感染的特异性和准确性诊断性能。对 612 份报告为 HCV 非反应性的随机选择的 254 份血清样本进行 HCV 抗体、ELISA 和 HCV RNA 检测，以进行确认诊断。15.74%的 ELISA 检测 HCV 抗体阳性，11.02%的巢式 RT-PCR 检测 HCV RNA 阳性。此外，还对 15 名 ALT 和 AST 值高的慢性丙型肝炎患者进行 HCV RNA 筛查，其中 5 名阳性患者的病毒载量范围为 1.2×10(2)至 4.4×10(6)IU/mL，这些样本来自静脉药物使用者和 HIV 合并感染个体。结果表明，HCV 快速免疫检测不能单独作为 HCV 感染筛查的绝对准确诊断工具，特别是在静脉药物使用者、血液透析、地中海贫血和 HIV 合并感染等高危人群中，这些人群需要经常进行 HCV 筛查。
