Evaluation of HBsAg Rapid Test Kits in Thailand
Keywords:
HBsAg rapid test kits, sensitivity, specificity, limit of detectionAbstract
Detection of Hepatitis B surface antigen (HBsAg) in blood, is useful for diagnosis of Hepatitis B virus (HBV) infection, determining needs for individual HBV immunization and screening for HBV in blood donors. In this study, we evaluated performance of HBsAg rapid test kits that were used in Thailand in 2016. A total of 11 products, manufactured in forms of either a cassette or a strip, were included to the study. Performance evaluation on sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) was examined using 150 and 200 known HBsAg positive and known HBsAg negative samples, respectively, as determined by 2 automatic machine-based HBsAg test kits. In addition, Limit of Detection (LOD), a parameter to determine analytical sensitivity, was evaluated using the 2nd WHO International Standard. Our results showed that, at 95% confidence level (95% CI), sensitivity was in a range of 98.0-98.67 (95% CI: 94.29-99.63%). Specificity was 100 percent (95% CI: 98.12-100 %). Accuracy was ranged from 99.14% to 99.43%. All test kits had LOD values between 0.52 to 8 IU/ml. According to WHO and International Consortium for Blood Safety criteria, performance of HBsAg rapid test kits passed the criteria for diagnosis only. Our findings suggested that HBsAg rapid test kits can be used for initial diagnosis but cannot be used for screening blood donors.
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