Abstract
Objective: To determine the diagnostic accuracy of combo Immunochromatographic (ICT) kit compared with Enzyme Linked Immunosorbent Assay (ELISA) to diagnose Hepatitis B, Hepatitis C, and HIV infection.
Place and Duration of Study: Department of Virology, Armed Forces Institute of Pathology Rawalpindi, Pakistan, from Jul to Dec 2023.
Study Design: Diagnostic accuracy study.
Methodology: A total of 1217 blood specimens were collected and tested for HBsAg, Anti-HCV Ab, and Anti-HIV Ab using both an ICT kit and ELISA. The results of positive and negative specimens on ICT were compared with ELISA, which was taken as gold standard. Sensitivity, specificity, positive predictive value, negative predictive value, diagnostic accuracy, and Kappa coefficient were calculated.
Results: Regarding HBsAg detection, the ICT kit showed 97.8% sensitivity, 99.8% specificity, a positive predictive value of 92.0%, and a negative predictive value of 99.9%. For anti-HCV antibodies, sensitivity was 98.8%, specificity 99.6%, a positive predictive value 93.5% and a negative predictive value 99.9%. For anti-HIV antibodies, sensitivity, specificity, positive predictive value, and negative predictive value were all 100.0%. Overall, the ICT kit demonstrated 99.0% diagnostic accuracy with a Kappa coefficient above 0.9, indicating excellent agreement with ELISA results.
Conclusion: The study highlighted the combo ICT kit as a cost-effective alternative to ELISA for detecting Hepatitis B, Hepatitis C, and HIV infections. With 99% diagnostic accuracy and a Kappa coefficient above 0.9, it demonstrated high sensitivity, specificity, PPV, and NPV.