Year: 2026 | Month: July | Volume: 16 | Issue: 7 | Pages: 310-318
DOI: https://doi.org/10.52403/ijhsr.20260732
Diagnostic Performance of Rapid Test Cassette Compared to Enzyme-Linked Immunosorbent Assay in the Screening of Anti-HBs in Sokoto, Nigeria
B Hali1, A Yakubu2, U.M Ango3, S Umar4
1Department of Medical Microbiology and Parasitology, Faculty of Basic Clinical Sciences,
College of Health Sciences, Usmanu Danfodiyo University, Sokoto, Nigeria
2Department of Medicine, Faculty of Clinical Sciences, College of Health Sciences,
Usmanu Danfodiyo University, Sokoto, Nigeria
3Department of Community Medicine, Faculty of Clinical Sciences, College of Health Sciences,
Usmanu Danfodiyo University, Sokoto, Nigeria
4Department of Public Health, SAISA University of Medical Sciences and Technology, Sokoto, Nigeria.
Corresponding Author: Dr. Bello Hali
ABSTRACT
Background and aims: Hepatitis B virus (HBV) infection remains a major global public health challenge and is highly endemic in sub-Saharan Africa, particularly Nigeria. Detection of hepatitis B surface antibody (anti-HBs) is essential for identifying previous HBV exposure, assessing post-vaccination immunity, and guiding clinical management in individuals who test negative for hepatitis B surface antigen (HBsAg). Although enzyme-linked immunosorbent assay (ELISA) is the reference method for anti-HBs detection, its routine use is limited in resource-constrained settings because of cost, infrastructure requirements, and longer turnaround time. This study evaluated the diagnostic performance of the Egens anti-HBs rapid test cassette compared with ELISA for screening anti-HBs among selected populations in Sokoto, Nigeria.
Materials and Methods: A hospital-based cross-sectional diagnostic accuracy study was conducted between February and April 2026 among 262 participants, including individuals living with chronic HBV infection, human immunodeficiency virus (HIV) infection, Mycobacterium tuberculosis infection, and apparently healthy controls. Serum anti-HBs was detected using the Egens rapid test cassette and a commercial ELISA kit, with ELISA serving as the reference standard. Diagnostic performance indices, including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), overall diagnostic accuracy, and Cohen's kappa coefficient, were calculated with corresponding 95% confidence intervals. Fisher's exact test was used to assess associations between participant characteristics and true-positive rapid test results.
Results: The mean age of participants was 29 ± 14 years, and 73.3% were male. Anti-HBs positivity was detected in 26.7% by ELISA and 27.5% by the rapid test cassette. The rapid test demonstrated a sensitivity of 95.7% (95% CI: 91.7–99.7), specificity of 97.4% (95% CI: 95.4–99.4), PPV of 93.1% (95% CI: 87.1–99.1), NPV of 98.4% (95% CI: 96.6–100.0), and an overall diagnostic accuracy of 96.9% (95% CI: 94.9–98.9). Agreement between the rapid test and ELISA was almost perfect (Cohen's κ = 0.903, P = 0.001). True-positive rapid test results were significantly associated with participant group, male sex, and age category (all P < 0.05).
Conclusion: The Egens anti-HBs rapid test cassette demonstrated excellent diagnostic performance and almost perfect agreement with ELISA, indicating that it is a reliable alternative for anti-HBs screening, particularly in resource-limited settings where access to conventional laboratory testing is limited.
Key words: Hepatitis B virus; Anti-HBs; Enzyme-linked immunosorbent assay; Rapid diagnostic test; Diagnostic accuracy; Nigeria.