Zhang Lei*, Yang Feng, Zhu Junzhe
Background: HBsAg Rapid Diagnostic Tests (RDT) has been developed for the detection of hepatitis B surface antigen (HBsAg). They represent a promising alternative to enzyme immunoassays and a powerful tool for large-scale screening and diagnosis of HBV infection, especially in regions without access to serological and molecular testing (3).
Objective: This study aimed to evaluate the effectiveness of the AllTest HBsAg Rapid Test Kits for the qualitative detection of Hepatitis B Surface Antigen (HBsAg) in whole blood, serum or plasma to aid in the diagnosis of hepatitis B virus (HBV) infection.
Method: A rapid in vitro diagnostic test device for detection of HBsAg in Whole Blood, Serum or Plasma was evaluated and compared with ELISA serology. Sensitivity (Se) and specificity (Sp) were used to estimate test performance.
Results: The relative Se and Sp (lower bound of 95% CI) were as follows: >99.9% and 99.6% for serum or plasma specimens; and >99.9% and 99.5% for whole blood specimens.
Conclusion: The All Test HBsAg Rapid Test Kit could be considered an ideal method for HBV screening, given the ease of use, fast testing time, and high accuracy. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of HBsAg in whole blood, serum or plasma.
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