Hirzel, Cédric; Pfister, Stefan; Gorgievski, Meri; Wandeler, Gilles; Zürcher, Samuel (2015). Performance of HBsAg point-of-care tests for detection of diagnostic escape-variants in clinical samples. Journal of clinical virology, 69, pp. 33-35. Elsevier 10.1016/j.jcv.2015.05.024
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JCV-D-15-00233R1.pdf - Accepted Version Available under License Creative Commons: Attribution-Noncommercial-No Derivative Works (CC-BY-NC-ND). Download (107kB) | Preview |
BACKGROUND
Hepatitis B viruses (HBV) harboring mutations in the a-determinant of the Hepatitis B surface antigen (HBsAg) are associated with reduced reactivity of HBsAg assays.
OBJECTIVES
To evaluate the sensitivity and specificity of three HBsAg point-of-care tests for the detection of HBsAg of viruses harboring HBsAg mutations.
STUDY DESIGN
A selection of 50 clinical plasma samples containing HBV with HBsAg mutations was used to evaluate the performance of three HBsAg point-of-care tests (Vikia(®), bioMérieux, Marcy-L'Étoile, France. Alere Determine HBsAg™, Iverness Biomedical Innovations, Köln, Germany. Quick Profile™, LumiQuick Diagnostics, California, USA) and compared to the ARCHITECT HBsAg Qualitative(®) assay (Abbott Laboratories, Sligo, Ireland).
RESULTS
The sensitivity of the point-of-care tests ranged from 98% to 100%. The only false-negative result occurred using the Quick Profile™ assay with a virus harboring a D144A mutation.
CONCLUSIONS
The evaluated point-of-care tests revealed an excellent sensitivity in detecting HBV samples harboring HBsAg mutations.
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