Olinger C.M., Weber B., Otegbayo J.A., Ammerlaan W., Van Der Taelem-Brulé N., Muller C.P.
Institute of Immunology, National Public Health Laboratory, 20a, rue Auguste Lumière, Luxembourg 1950, Luxembourg; Laboratoires Réunis Junglinster, Z.A.C. Langwies, Junglinster 6131, Luxembourg; Institut für Medizinische Virologie, Universitätskliniken Fr
Olinger, C.M., Institute of Immunology, National Public Health Laboratory, 20a, rue Auguste Lumière, Luxembourg 1950, Luxembourg; Weber, B., Laboratoires Réunis Junglinster, Z.A.C. Langwies, Junglinster 6131, Luxembourg, Institut für Medizinische Virologie, Universitätskliniken Frankfurt, Frankfurt, Germany; Otegbayo, J.A., Gastrointestinal/Liver Unit, Department of Medicine, University of Ibadan/University College Hospital, Ibadan, Nigeria; Ammerlaan, W., Institute of Immunology, National Public Health Laboratory, 20a, rue Auguste Lumière, Luxembourg 1950, Luxembourg; Van Der Taelem-Brulé, N., Laboratoires Réunis Junglinster, Z.A.C. Langwies, Junglinster 6131, Luxembourg; Muller, C.P., Institute of Immunology, National Public Health Laboratory, 20a, rue Auguste Lumière, Luxembourg 1950, Luxembourg
The major neutralizing epitope, the "a" determinant of the hepatitis B virus (HBV) genotype E surface antigen (HBsAg) is most divergent from that of genotype A, which is used for preparing monoclonal antibodies used in commercially available HBV reagents. To evaluate the performance of the latest generation of HBsAg detection assays with respect to genotype E HBsAg. Three commercial assays were evaluated using sera from 200 Nigerian patients compared to the preS/S sequence of DNA positive samples. Out of 200 samples, 61 and 103 gave concordant positive and negative results between the three HBsAg assays. Of 36 samples with discordant results, 35 were confirmed negative by neutralisation. One of the three assays showed significantly high rate of false positives (29 of 35). DNA positive samples with no detectable HBsAg or reduced HBsAg detection signals (<75% of mean signal obtained with HBsAg positive samples) revealed several mutations (V14A, F46S, N48T, L49R, I49T, D51G, A53V, P54L, Q82P, F83C, L127P, A184V, T189I, S204N, V224A), mostly outside the a-determinant. Several of these mutations are found as wild type nucleotides normally in genotype A and only exceptionally in genotype E. All three assays showed comparable sensitivities for genotype E HBsAg detection (98.4-100%) but differed considerably in specificity (84-99%). Failure to detect HBsAg antigen and differences in signal intensity were mainly associated with mutations in the preS/S gene outside the "a" determinant. © 2007 Springer-Verlag.
hepatitis B(e) antigen; nucleotide; antigen detection; article; diagnostic test; DNA sequence; gene mutation; genotype; Hepatitis B virus; human; immunoassay; major clinical study; Nigeria; priority journal; serum; signal transduction; virus gene; wild type; DNA, Viral; Genotype; Hepatitis B Surface Antigens; Hepatitis B virus; Humans; Mutation; Protein Precursors; Sensitivity and Specificity; Variation (Genetics)