Improving Linkage to Care of Hepatitis C: Clinical Validation of GeneXpert® HCV Viral Load Point-of-Care Assay in Indonesia

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  • 1 Eijkman Institute for Molecular Biology, Jakarta, Indonesia;
  • 2 Faculty of Medicine, Universitas Hasanuddin, Makassar, Indonesia;
  • 3 Virology Laboratory, Dharmais National Cancer Hospital, Jakarta, Indonesia;
  • 4 Division of Gastroenterology, Department of Internal Medicine, Abdoel Wahab Sjahranie Regional General Hospital, Samarinda, Indonesia;
  • 5 Faculty of Medicine and Health, University of Sydney, New South Wales, Australia

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.

Author Notes

Address correspondence to David H. Muljono, Jl. Diponegoro 69, Jakarta DKI, Indonesia 14030. E-mail: davidhm@eijkman.go.id

Authors’ addresses: Meta Dewi Thedja, Dhita Prabasari Wibowo, Korri Elvanita El-Khobar, and Susan Irawati Ie, Eijkman Institute for Molecular Biology, Jakarta, Indonesia, E-mails: metadewit@yahoo.com, dhita@eijkman.go.id, korri@eijkman.go.id, and mikumitsu@yahoo.com.au. Turyadi, Eijkman Institute for Molecular Biology, Jakarta, Indonesia, and Faculty of Medicine, Universitas Hasanuddin, Makassar, Indonesia, E-mail: yadi@eijkman.go.id. Lyana Setiawan, Virology Laboratory, Dharmais National Cancer Hospital, Jakarta, Indonesia, E-mail: setiawanlyana@gmail.com. Ignatia Sinta Murti, Division of Gastroenterology, Department of Internal Medicine, Abdoel Wahab Sjahranie Regional General Hospital, Samarinda, Indonesia, E-mail: ignatiasintamurti@yahoo.com. David Handojo Muljono, Eijkman Institute for Molecular Biology, Jakarta, Indonesia, Faculty of Medicine, Universitas Hasanuddin, Makassar, Indonesia, and Faculty of Medicine and Health, University of Sydney, New South Wales, Australia, E-mail: davidhm@eijkman.go.id.

Financial support: This study was funded by the 2017 Research Grant of the Ministry of Research, Technology, and Higher Education (RISTEK-DIKTI), Republic of Indonesia to the Eijkman Institute for Molecular Biology. The funding agency was not involved in any aspect of the study, including design, analysis, or interpretation of results.

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