Cédric Hirzel1, Stefan Pfister2, Meri Gorgievski-Hrisoho2, Gilles Wandeler3, Samuel Zuercher2. 1. Department of Infectious Diseases, Bern University Hospital and University of Bern, Switzerland. Electronic address: cedric.hirzel@insel.ch. 2. Institute for Infectious Diseases, University of Bern, Bern, Switzerland. 3. Department of Infectious Diseases, Bern University Hospital and University of Bern, Switzerland; Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
Abstract
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.
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.
Authors: Maria V Konopleva; Maxim S Belenikin; Andrei V Shanko; Alexey I Bazhenov; Sergei A Kiryanov; Tatyana A Tupoleva; Maria V Sokolova; Alexander V Pronin; Tatyana A Semenenko; Anatoly P Suslov Journal: Diagnostics (Basel) Date: 2021-05-27