This study presents a retrospective assessment of the diagnostic performance of the newly developed hepatitis B core-related antigen rapid diagnostic test (HBcrAg-RDT) in detecting plasma samples with elevated hepatitis B virus (HBV) DNA levels (≥200,000 IU/ml) in Yaoundé, Cameroon. Samples were collected consecutively from treatment-naïve adults living with HBV between January 1, 2021, and June 30, 2023. Analyzing 146 samples from participants with a median age of 36 years, the HBcrAg-RDT exhibited a sensitivity of 97.5% (95% CI: 86.8-99.9) and a specificity of 77.4% (68.2-84.9) when compared to real-time PCR as the reference standard. These findings suggest that HBcrAg-RDT holds promise as a valuable point-of-care tool for diagnosing high HBV DNA levels, particularly in resource-limited settings. Further research will refine its practicality and effectiveness.
Keywords: Africa; Elimination; Hepatitis B core-related antigen; Point-of-care tests; Sensitivity and specificity; Validation studies.
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