Diagnostic performance of serological assays for anti-HBs testing: Results from a quality assessment program |
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| Institution: | 1. Academic Collaborative Centre for Public Health AMPHI, Department of Primary and Community Care, Radboud University Nijmegen Medical Centre, The Netherlands;2. Centre for Infectious Disease Control, Netherlands Institute of Public Health and the Environment, Bilthoven, The Netherlands;3. Centre of Infectious Diseases, Leiden University Medical Centre, Leiden, The Netherlands;4. MCA Laboratory, Queen Beatrix Hospital, Winterswijk, The Netherlands;5. On behalf of the Dutch Foundation for Quality Assessment in Medical Laboratories (SKML), The Netherlands;6. Department of Sexual Health, Infectious Diseases and Environmental Health, South Limburg Public Health Service, The Netherlands;7. Department of Medical Microbiology, School of Public Health and Primary Care (CAPHRI), Maastricht University Medical Center (MUMC+), Maastricht, The Netherlands;8. Department of Medical Microbiology, Leiden University Medical Centre, The Netherlands;1. Department of Zoonotic Diseases, National Research Centre, Dokki, 12622, Giza, Egypt;2. Department of Animal Hygiene and Zoonosis, Faculty of Veterinary Medicine, Assiut University, Assiut, Egypt;3. Hydrobiology Department, National Research Centre, Dokki, 12622, Giza, Egypt;4. Department of Animal Reproduction and Artificial Insemination, National Research Centre, Dokki, Giza, Egypt;5. Department of Community Medicine Research, National Research Centre, Cairo, Egypt;6. Department of Biochemistry and Nutrition, Faculty of Women for Arts, Sciences and Education, Ain Shams University, Heliopolis, Cairo, Egypt;1. Pneumology Department, ULS-Guarda, Sousa Martins Hospital, Guarda, Portugal;2. Pneumology Department, HG-CHUC, Sleep Medicine Center, Coimbra, Portugal;3. Neurophysiology Department, HG-CHUC, Sleep Medicine Center, Coimbra, Portugal |
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| Abstract: | BackgroundPost-vaccination testing after hepatitis B vaccination is indispensable to evaluate long-term immunological protection. Using a threshold level of antibodies against hepatitis B surface antigen (anti-HBs) to define serological protection, implies reproducible and valid measurements of different diagnostic assays.ObjectivesIn this study we assess the performance of currently used anti-HBs assays.Study designIn 2013, 45 laboratories participated in an external quality assessment program using pooled anti-HBs serum samples around the cutoff values 10 IU/l and 100 IU/l. Laboratories used either Axsym (Abbott Laboratories), Architect (Abbott Laboratories), Access (Beckman-Coulter), ADVIA Centaur anti-HBs2 (Siemens Healthcare Diagnostics), Elecsys, Modular or Cobas (Roche Diagnostics) or Vidas Total Quick (Biomerieux) for anti-HBs titre quantification. We analysed covariance using mixed-model repeated measures. To assess sensitivity/specificity and agreement, a true positive or true negative result was defined as an anti-HBs titre respectively above or below the cutoff value by ≥4 of 6 assays.ResultsDifferent anti-HBs assays were associated with statistically significant (P < 0.05) differences in anti-HBs titres in all dilutions. Sensitivity and specificity ranged respectively from 64%-100% and 95%-100%. Agreement between assays around an anti-HBs titre cutoff value of 10 IU/l ranged from 93%-100% and was 44% for a cutoff value of 100 IU/l.ConclusionsAround a cutoff value of 10 IU/l use of the Access assay may result in false-negative results. Concerning the cutoff value of 100 IU/l, a sample being classified below or above this cutoff relied heavily on the specific assay used, with both the Architect and the Access resulting in false-negative results. |
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| Keywords: | Hepatitis B Serology Diagnostic test |
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