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Evaluation of the Diagnostic Accuracy of the HBsAg Rapid Test for Hepatitis B Virus Infection

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DOI: 10.23977/medsc.2024.050301 | Downloads: 6 | Views: 185


Zhang Lei 1, Yang Feng 2, Zhu Junzhe 3


1 Zhejiang Gongshang University, Hangzhou, Zhejiang, 310018, China
2 Community Health Service Center, Yipeng Street, Qiantang District, Hangzhou, Zhejiang, 310000, China
3 Wenzhou Medical University, Wenzhou, Zhejiang, 310000, China

Corresponding Author

Zhang Lei


Hepatitis B virus (HBV) infection presents a notable worldwide health burden, affecting millions of people globally. It can lead to chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma. Accurate diagnosis of HBV infection is vital for effectively managing and preventing disease progression. In this investigation, we aimed to assess the diagnostic efficacy of the HBsAg Rapid Test. To assess its sensitivity, specificity, and accuracy, we conducted a comprehensive analysis of 602 specimens. This test exhibited an accuracy of 99.7%, with a sensitivity exceeding 99.9% and a specificity of 99.4%. Additional evaluations on cross-reactivity affirmed the test's specificity, as it consistently produced negative outcomes for different viral strains. Manufactured by Hangzhou AllTest Biotech Co., Ltd, the HBsAg Rapid Test provides rapid and reliable results, demonstrating a high level of accuracy. Consequently, it serves as a valuable diagnostic instrument in clinical settings, especially in resource-constrained environments. The timely detection enables prompt intervention and effective Hepatitis B management, resulting in improved patient outcomes and reduced transmission of the virus.


Hepatitis B virus; Diagnosis; Point-of-care; Sensitivity


Zhang Lei, Yang Feng, Zhu Junzhe, Evaluation of the Diagnostic Accuracy of the HBsAg Rapid Test for Hepatitis B Virus Infection. MEDS Clinical Medicine (2024) Vol. 5: 1-6. DOI:


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