European collaborative evaluation of Enzygnost HBsAg 6.0: performance on hepatitis B virus surface antigen variants
Résumé
Amino acid changes within the major antigenic determinant of the hepatitis B virus (HBV) surface antigen (HBsAg) may eventually modify the antigenic properties of the protein and may have impact on the sensitivity of diagnostic assays. Modifications in the design of an assay can, however, improve significantly its capability to detect these mutants. One-hundred and forty-seven clinical samples containing HBsAg variants, and 54 supernatants of cells expressing recombinant HBsAg mutants were tested by two generations of a commercial HBsAg test (Enzygnost® HBsAg 5.0 and 6.0, Siemens Healthcare Diagnostics Products GmbH, Marburg, Germany), and results were compared. A significant improvement was demonstrated for the second test by comparing mean and individual sample/cut-off values, as well as by the rescue of several samples displaying amino acid changes in residues 120 and 145 of the HBsAg that were recorded negative by the former test. Results showed that modifications in design introduced in the last generation improved very much the ability of the test to detect HBsAg mutants, and that troubles in detecting such HBV variants should not be expected from the routine use of the test in diagnostic laboratories and in blood transfusion centres.
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