Evaluating performance of the Bioline™ HCV point-of-care test in Ghana

Abstract

BACKGROUND : Hepatitis C Virus (HCV) causes liver diseases including chronic hepatitis, cirrhosis, and hepatocellular carcinoma. In low- and middle-income countries (LMICs), particularly sub-Saharan Africa (SSA), HCV diagnostic resources are limited. Moreover, most evaluations of point-of-care (POC) invitro diagnostics (IVDs) are conducted outside the region using non-African populations, which may not reflect their performance in local settings where they are mostly used. This study assessed the diagnostic performance of the Bioline™ HCV POC test in Ghanaian HCV target populations. METHODS : A cross-sectional field evaluation was conducted among HCV priority populations including incarcerated individuals, patients requiring HCV testing, and voluntary blood donors undergoing pre-donation screening. Venous blood samples were tested using the Bioline™ HCV POC test, and the results were compared with the Enzyme-Linked Immunosorbent Assay (ELISA) reference standard. The sensitivity, specificity, test efficiency, Youden index, predictive values, likelihood ratios, and receiver operating characteristic (ROC) indicators were calculated. RESULTS : The Bioline™ HCV POC test demonstrated a sensitivity of 96.7% (95% CI: 82.8–99.9%), specificity of 99.8% (95% CI: 98.9–100%), and positive and negative predictive values of 96.7% (95% CI: 82.8–99.9%) and 99.8% (95% CI: 98.9–100%), respectively. The test efficiency was 99.6% (98.6–99.9%), Youden index 0.97 (0.82–0.99) with a ROC area of 0.98 and highly favorable likelihood ratios (LR + 483.5, LR − 0.03). CONCLUSION : This study highlights the high diagnostic performance of the Bioline™ HCV POC test in Ghanaian populations. The test’s reliability underscores its potential as a valuable tool for HCV screening and early detection in resource-limited settings, contributing to efforts to reduce the global HCV burden. TRIAL REGISTRATION : This study is part of a diagnostic trial registered in the Pan African Clinical Trial Registry (https://pactr.samrc.ac.za) on 24th October 2024 with trial registration number: PACTR202410837698664.