Performance of HBsAg point-of-care tests for detection of diagnostic escape-variants in clinical samples

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 (R), bioMerieux, Marcy-LEtoile, France. Alere Determine HBsAg (TM), Iverness Biomedical Innovations, Koln, Germany. Quick Profile (TM), LumiQuick Diagnostics, California, USA) and compared to the ARCHITECT HBsAg Qualitative (R) 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 (TM) 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. (C) 2015 Elsevier B.V. All rights reserved.