Evidence toward a novel approach to hepatitis C virus testing in resource-limited settings
Freiman, J. Morgan
MetadataShow full item record
RATIONALE: A low cost point of care test (POCT) to diagnose hepatitis C virus (HCV) viremia could be a critical step toward HCV elimination. The aim of this study is to inform the limit of detection (LOD) for an affordable POC test. METHODS: This study analyzed a convenience sample of cross-sectional HCV testing data from reference laboratories and clinical research studies in 9 countries. Participants of all ages with quantified HCV viremia were included. We analyzed the distribution of HCV viral load for the first detectable HCV RNA available, and derived the clinical sensitivity for a POCT with an LOD of 3 log IU/mL. Bivariate and multivariate analyses were then performed to identify demographic and clinical characteristics associated with low-level viremia (< 3 log IU/mL). RESULTS: The dataset included 53,295 participants from Cambodia, Canada, Cameroon, Georgia, Indonesia, Malaysia, Pakistan, Thailand, and Vietnam. Log HCV RNA was normally distributed, and ≥ 3 log IU/mL corresponded with clinical sensitivity of 98%. Neither HIV co-infection nor cirrhosis were significantly associated with low-level viremia, whereas bivariate analyses showed increased odds of 2.47 (95% CI 2.04, 2.99) for low-level HCV RNA among those ≤ 30 years old compared to those > 30, and an OR of 1.17 (1.02, 1.34) among females compared to males. Stepwise multivariate regression found no significant confounding. CONCLUSION: In this global dataset, a POCT with a LOD of 3 log IU/mL would identify 98% of chronic HCV infections. The increase OR among those ≤ 30 years old year olds is likely explained by a greater frequency among younger persons of recent infection, where fluctuating viremia is well described. A POCT for HCV that could identify persons with 3 log IU/mL or greater would likely facilitate affordable product development and expand the reach of HCV testing in resource-limited settings.