Deriving the optimal limit of detection for an HCV point-of-care test for viraemic infection: Analysis of a global dataset

Journal of Hepatology
J Morgan FreimanBenjamin Linas

Abstract

Affordable point-of-care tests for hepatitis C (HCV) viraemia are needed to improve access to treatment in low- and middle-income countries. Our aims were to determine the target limit of detection (LOD) necessary to diagnose the majority of people with HCV eligible for treatment, and identify characteristics associated with low-level viraemia (LLV) (defined as the lowest 3% of the distribution of HCV RNA) to understand those at risk of being misdiagnosed. We established a multi-country cross-sectional dataset of first available quantitative HCV RNA measurements linked to demographic and clinical data. We excluded individuals on HCV treatment. We analysed the distribution of HCV RNA and determined critical thresholds for detection of HCV viraemia. We then performed logistic regression to evaluate factors associated with LLV, and derived relative sensitivities for significant covariates. The dataset included 66,640 individuals with HCV viraemia from across the world. The LOD for the 95th and 99th percentiles were 3,311 IU/ml and 214 IU/ml. The LOD for the 97th percentile was 1,318 IU/ml (95% CI 1,298.4-1,322.3). Factors associated with LLV, defined as HCV RNA <1,318 IU/ml, were younger age 18-30 vs. 51-64 years (odds ratios [OR]...Continue Reading

Citations

Nov 30, 2019·Liver International : Official Journal of the International Association for the Study of the Liver·Zameer MohamedMaud Lemoine
Jul 4, 2020·Open Forum Infectious Diseases·Stéphane ChevaliezStéphanie Dominguez
Oct 22, 2019·Lancet·C Wendy SpearmanMark Sonderup
Sep 29, 2021·Liver International : Official Journal of the International Association for the Study of the Liver·Andrea MarcellusiLoreta A Kondili

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