Comparative evaluation of rapid diagnostic test devices and real-time PCR for detection of HBsAg in Rivers State

Abstract

Background: Hepatitis B Virus (HBV) infection is a significant public health concern worldwide, especially in rejoins with highly endemicity such as sub-Saharan Africa. The HBV infection can lead to severe complications, including liver cirrhosis, hepatocellular carcinoma, and chronic liver disease, all of which contribute to considerable morbidity and mortality globally. Hepatitis B virus is 50-100 times more infectious than HIV and 10 times more infectious than Hepatitis C.
Aim: The aim of this study was to compare the sensitivity and specificity of rapid screening method with PCR method for detection of HBV among out-patients with clinical symptoms visiting Rivers State University Teaching Hospital, Port Harcourt.
Methodology: This was a cross-sectional study carried out on 130 subjects who visited RSUTH. Four different Rapid Diagnostic Test (RDT) kits for screening of HBV were used for this study. Positive RDT samples were further analyzed using PCR (Real-Time) for confirmation, quantification and comparison of HBV.
Result: The result obtained from the study showed that 71 samples were positive by PCR, while 59 samples were negative. Samples that reacted using Rapid HBV were 120, 117, 100, and 124 for CTK, Labacon, Rostec and Tell respectively. For non-reactivity; 10, 13, 30, and 6 samples were non-reactive for CTK, Labacon. Rostec, and Tell respectively. Comparing their sensitivity, it was observed that CTK, Labacon, Rostec, and Tell test kits had sensitivity of 100% each, and specificity of 16.9, 22, 38.9. and 10.1. The rapid test kits had an accuracy of 62.3, 64.6, 72.3 and 59.2% respectively.
Conclusion: This study posits that there should be a compulsory validation of RDT test kits for HBsAg detection by real-time PCR before being used in resource-limited settings. RDT kits can be ideal alternatives for diagnosis. However, a major concern in using these kits is their variable degrees of sensitivity and specificity