Hepatitis C virus (HCV) infection large-scale diagnosis and treatment are hampered by lack of a simple, rapid, and reliable point-of-care (POC) test, which poses a challenge for the elimination of hepatitis C as a public health problem. This study aimed to evaluate Cepheid Xpert® HCV Viral Load performance in comparison with the Roche Cobas® TaqMan® HCV Test using serum samples of HCV-infected patients in Indonesia. Viral load quantification was performed on 243 anti-HCV positive patients’ samples using both Xpert HCV VL and Roche HCV tests, followed by HCV genotyping by reverse hybridization. Strength of the 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 viral load values. Quantifiable viral load was detected in 180/243 (74.1%), with Xpert HCV VL sensitivity of 100% (95% CI 0.98, 1.00) and specificity of 98.4% (95% CI 0.91, 0.99) based on Roche HCV tests, while HCV genotypes were determined in 172/180 (95.6%) samples. There was a good correlation between both assays (r = 0.97, P < 0.001), overall and per genotype, with good concordance by Deming regression and a mean difference of −0.25 log10 IU/mL (95% CI −0.33, −0.18) by Bland–Altman plot analysis. Xpert HCV VL test was demonstrated as a POC platform with good performance for HCV diagnosis and treatment decision that would be beneficial for decentralized service in resource-limited areas. HCV testing sites, alongside additional GeneXpert modular systems distributed toward the fight against COVID-19, could ensure some continuity, once this pandemic is controlled.

Background. The host immune system plays an important role in hepatitis B virus (HBV) infection manifestation. Genetic polymorphisms of several inflammatory cytokines, including TNF-α and IL-10, have been associated with chronic hepatitis B (CHB) progression, although with contradicting results. CHB progression can be categorized into four phases, immune tolerance (IT), immune clearance (IC), low/no replicative (LR), and e-negative hepatitis (ENH), with HBeAg seroconversion as an important milestone. Here, we determined the association of TNF-α (rs1800629) and IL-10 (rs1800896 and rs1800872) SNPs in the context of CHB natural history progression, particularly to HBeAg seroconversion, in Indonesian CHB patients. Methods. A total of 287 subjects were recruited and categorized into distinct CHB phases based on HBeAg, viral load, and ALT levels. TNF-α and IL-10 SNPs were determined using PCR-RFLP and confirmed with direct sequencing. The association between SNP genotypes with CHB dynamics was determined using logistic regression presented as odds ratio (OR) with 95% CI. Results. No significant association was found between IL-10 -592A/C polymorphism and progression of IT and IC to LR, IT and IC to ENH, and LR to ENH phases in all the gene models. IL-10 rs1800896 and TNF-α rs1800629 could not be analyzed using logistic regression. Subjects’ age (≥40 years old) was significantly associated with IT and IC to LR (OR: 2.191, 95% CI 1.067–4.578, P = 0.034 ), IT and IC to ENH (OR: 7.460, 95% CI 3.316–18.310, P < 0.001 ), and LR to ENH (OR: 5.252, 95% CI 2.010–14.858, P = 0.001 ). Male gender was associated with LR to ENH (OR: 4.077, 95% CI 1.605–11.023, P = 0.004 ). Conclusions. Age and male gender were associated with CHB phase progression instead of the TNF-α and IL-10 polymorphisms. It would be beneficial to study not only the effect of host determinants but also the viral factor to understand the mechanisms of CHB phase progression.

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.