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.

中文翻译：

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评估三种大规模筛查丙型肝炎抗体的快速筛选测试。

丙型肝炎病毒（HCV）是全球领先的健康问题。HCV阳性个体中只有20％知道其阳性疾病状态。需要进行有效的HCV筛查测试，以筛查普通人群和高危人群并确定HCV沉默病例。在这项研究中，我们分析了三种快速HCV筛查试剂盒的性能。来自巴基斯坦的拉瓦尔品第和伊斯兰堡市的三个人群共计300名受试者。这三组分别是献血者（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的快速筛选测试：CTK Biotech的OnSite HCV Ab快速测试，SD Bioline一步抗HCV测试和Intec产品高级质量快速抗HCV测试。还将这三个快速测试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Roche Anti-HCV II测试进行了比较。总共分析了300个样本，其中208例抗HCV阳性，92例抗HCV阴性。Intec产品，SD Bioline和CTK Biotech的敏感性分别为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％，而Intec产品的PPV则为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。在这项研究中评估的快速测试可用于更大范围的肝炎筛查。