Abstract
Early diagnosis of chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections is pivotal for optimal disease management. Sensitivity and specificity of 19 rapid diagnostic test (RDT) kits by different manufacturers (ABON, CTK Biotech, Cypress Diagnostics, Green Gross, Human Diagnostic, Humasis, InTec, OraSure, SD Bioline, Wondfo) were assessed on serum samples of 270 Mongolians (90 seropositive for hepatitis B surface antigen (HBsAg), 90 seropositive for hepatitis C antibody (HCV-Ab), 90 healthy subjects). All tested RDTs for detection of HBsAg performed with average sensitivities and specificities of 100% and 99%, respectively. Albeit, overall sensitivity and specificity of RDTs for detection of HCV-Ab was somewhat lower compared to that of HBsAg RDTs (average sensitivity 98.9%, average specificity 96.7%). Specificity of RDTs for detection of HCV-Ab was dramatically lower among HBsAg positive individuals, who were 10.2 times more likely to show false positive test results. The results of our prospective study demonstrate that inexpensive, easy to handle RDTs are a promising tool in effective HBV- and HCV-screening especially in resource-limited settings.
Highlights
With about 1.4 million annual deaths, viral hepatitis is a major problem in global health [1,2]
None of the patients had any history of treatment with direct acting antiagents (DAAs) against hepatitis C virus (HCV) or nucleoside analogues against hepatitis B virus (HBV) since these drugs only gained widespread availability on the Mongolian market in late 2015
HCV-Ab serostatus had no effect on number of false positive test results with hepatitis B surface antigen (HBsAg) kits (p>0.05) with 7 out of 16 false positive results (FP) tests coming from the HCV-Ab positive group, odds ratio 0.78 (0.29–2.09)
Summary
With about 1.4 million annual deaths, viral hepatitis is a major problem in global health [1,2]. Most deaths are attributable to chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections and their long-term complications–liver cirrhosis and hepatocellular carcinoma. Diagnosis and linkage to care is pivotal to prevent these complications. As early stages of HBV and HCV infection are often asymptomatic, few people are diagnosed early.
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