Utility of hepatitis C virus core antigen testing for diagnosis and treatment monitoring in HCV infection: A study from India.

PURPOSE The major bottleneck in most developing countries to attain the WHO goal of eliminating hepatitis C as a public health threat by 2030 is the limited access to molecular testing and loss of infected patients to follow up. Many of the hepatitis C virus (HCV) infected patients fail to get the confirmatory HCV RNA test done after initial screening for anti-HCV antibody. The hepatitis C core antigen (HCVcAg) chemiluminescence-based assay which is newly introduced in the Indian health setup could prove to be a potential marker in the single-point screening and confirmation of HCV infection. This study was done to evaluate the performance of the HCVcAg assay for diagnosis and treatment monitoring of patients with HCV infection. METHODS In this retrospective study 208 archived plasma samples from 184 patients were retrieved and all three markers for the laboratory diagnosis of HCV infection, anti-HCV, HCV RNA and HCVcAg were performed in a single freeze thaw cycle. For a subset of patients (n ​= ​24), paired samples, baseline samples and samples collected at 12 weeks after completion of treatment (SVR12) were available. RESULTS The sensitivity and specificity of the HCVcAg assay were 91.58% and 99.12% respectively with HCV RNA as the gold standard for the detection of active infection. There was a strong correlation between HCVcAg and HCV RNA (R ​= ​0.85, p ​< ​0•0001). Among the paired samples, the concordance between the HCVcAg and HCV RNA at baseline and at SVR12 was 95.8%. CONCLUSION The HCVcAg assay showed a good correlation with the gold standard HCV RNA assay, especially in the case of treatment naive patients. Thus, the use of HCVcAg assay as tool for testing and confirmation of HCV infection has the potential to increase the uptake of HCV testing.