Waheed Yasir, Najmi Muzammil Hasan, Aziz Hafsa, Khalid Sumbul, Waheed Hasnain, Imran Muhammad, Ahmad Bashir
Foundation University Medical College, Foundation University Islamabad, DHA-I Islamabad (44000), Pakistan.
Nuclear Medicine Oncology and Radiotherapy Institute Islamabad, Islamabad (44000), Pakistan.
Crit Rev Eukaryot Gene Expr. 2019;29(1):25-28. doi: 10.1615/CritRevEukaryotGeneExpr.2018025062.
Hepatitis C virus (HCV) is a leading health problem across the globe. Only 20% of HCV positive individuals know their positive disease status. Effective HCV screening tests are required to screen both general and high-risk populations and identify the silent cases of HCV. In this study, we analyzed the performance of three rapid HCV screening kits. A total of 300 subjects from three populations groups, were enrolled from Rawalpindi and Islamabad cities of Pakistan. The three groups were blood donors (n = 50), pregnant women (n = 50), and hepatitis C positive individuals (200). Blood samples of all the individuals were screened on three rapid screening tests for anti-HCV: CTK Biotech's OnSite HCV Ab Rapid Test, SD Bioline One Step anti-HCV test, and Intec Products Advanced Quality Rapid Anti-HCV Test. The performance of these three rapid tests was also compared with the Roche Anti-HCV II test performed on the cobas 601 platform based on the electrochemiluminescence immunoassay principle. In total, 300 samples were analyzed in this study, out of which 208 were positive for anti-HCV positive and 92 were negative for anti-HCV. The sensitivities of the Intec product, SD Bioline, and CTK Biotech were 98.56%, 97.59%, and 95.67%, respectively. The specificity of SD Bioline and CTK Biotech were 100%, whereas Intec products showed 98.91% specificity. The positive predictive value (PPV) of SD Bioline and CTK Biotech was 100%, but Intec products showed 99.51% PPV. The negative predictive values of the Intec product, SD Bioline, and CTK Biotech were 96.80%, 94.84%, and 91.09%, respectively. There is a dire need to speed up HCV screening to achieve the targets in the World Health Organization global viral hepatitis strategy (2016-2021). The rapid tests evaluated in this study can be used in hepatitis screening on much larger scales.
丙型肝炎病毒（HCV）是全球主要的健康问题。只有20%的HCV阳性个体知道自己的疾病阳性状态。需要有效的HCV筛查测试来筛查普通人群和高危人群，并识别HCV的隐匿病例。在本研究中，我们分析了三种快速HCV筛查试剂盒的性能。从巴基斯坦拉瓦尔品第和伊斯兰堡市招募了来自三个群体的300名受试者。这三个组分别是献血者（n = 50）、孕妇（n = 50）和丙型肝炎阳性个体（200）。对所有个体的血液样本进行了三种抗HCV快速筛查测试：CTK Biotech的OnSite HCV Ab快速检测、SD Bioline一步法抗HCV检测和Intec Products高级质量快速抗HCV检测。还将这三种快速检测的性能与基于电化学发光免疫分析原理在cobas 601平台上进行的罗氏抗HCV II检测进行了比较。本研究共分析了300个样本，其中208个抗HCV阳性，92个抗HCV阴性。Intec产品、SD Bioline和CTK Biotech的灵敏度分别为98.56%、97.59%和95.67%。SD Bioline和CTK Biotech的特异性为100%，而Intec产品的特异性为98.91%。SD Bioline和CTK Biotech的阳性预测值（PPV）为100%，但Intec产品的PPV为99.51%。Intec产品、SD Bioline和CTK Biotech的阴性预测值分别为96.80%、94.84%和91.09%。迫切需要加快HCV筛查，以实现世界卫生组织全球病毒性肝炎战略（2016 - 2021年）中的目标。本研究中评估的快速检测可用于更大规模的肝炎筛查。
