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Evaluating performance of the Bioline™ HCV point-of-care test in Ghana
Evans Duah1, Evans Mantiri Mathebula2, Kuhlula Maluleke2
1School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria, 0002, South Africa. evans.duah@tuks.co.za.
Insights
The Bioline™ Hepatitis C Virus (HCV) point-of-care test shows high accuracy in Ghana. This reliable diagnostic tool is suitable for early HCV detection in resource-limited areas.
Area of Science:
- Infectious Diseases
- Hepatology
- Public Health Diagnostics
Background:
- Hepatitis C Virus (HCV) infection leads to severe liver conditions like cirrhosis and cancer.
- Sub-Saharan Africa faces challenges with limited diagnostic resources for HCV.
- Existing point-of-care diagnostic evaluations often use non-African populations, potentially misrepresenting performance in local settings.
Purpose of the Study:
- To assess the diagnostic accuracy of the Bioline™ HCV point-of-care (POC) test.
- To evaluate the test's performance in Ghanaian populations, including incarcerated individuals, patients needing testing, and blood donors.
- To compare POC test results against a standard Enzyme-Linked Immunosorbent Assay (ELISA).
Main Methods:
- A cross-sectional field evaluation was performed.
- Venous blood samples were collected from priority HCV populations.
- The Bioline™ HCV POC test results were compared with ELISA reference standards.
Main Results:
- The Bioline™ HCV POC test achieved high sensitivity (96.7%) and specificity (99.8%).
- Positive and negative predictive values were also high, at 96.7% and 99.8%, respectively.
- Excellent test efficiency (99.6%), Youden index (0.97), and ROC area (0.98) were observed.
Conclusions:
- The Bioline™ HCV POC test demonstrates strong diagnostic performance in Ghanaian populations.
- Its reliability makes it a valuable tool for HCV screening and early detection in resource-limited settings.
- The study supports the use of this POC test to help reduce the global HCV burden.
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.
