Improving linkage to care of hepatitis C: Evaluation of GeneXpert® HCV Viral Load Point-of-Care Assay in Indonesia

Abstract

Background: Lack of simple, rapid, and reliable point-of-care (POC) test hampers large-scale diagnosis and treatment of hepatitis C virus (HCV) infection and pose a challenge for its elimination as a public health threat. This study aimed to evaluate Cepheid Xpert® HCV Viral Load performance in comparison to Roche Cobas® TaqMan® HCV Test using HCV-samples with various genotypes in Indonesia.Methods: Viral load (VL) quantification was performed on 243 anti-HCV positive patients’ samples using both Xpert and Roche HCV tests, followed by HCV genotyping by reverse hybridization. Strength of relationship between the assays was measured by Pearson correlation coefficient, while level of agreement was analyzed by Deming regression and Bland-Altman plot analysis using log10-transformed VL values.Results: Quantifiable VL was detected in 180/243 (74.1%), with Xpert sensitivity of 100% (95% CI 0.98, 1.00) and specificity of 98.41% (95% CI 0.91, 0.99), while HCV genotypes were determined in 172/180 (95.6%) samples. There was a very good correlation between both assays (r = 0.97, P < 0.001), overall and per genotype, with good concordance by Deming regression and mean difference of −0.25 log10 IU/mL (95% CI −0.33, −0.18) by Bland-Altman plot analysis.Conclusion: Good performance of Xpert HCV Viral Load test was demonstrated as a POC platform for HCV diagnosis and treatment decision, which would be beneficial for decentralized service in resource-limited areas.