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J Clin Virol. 2017 Feb;87:17-22. doi: 10.1016/j.jcv.2016.12.002. Epub 2016 Dec 7.

Diagnostic performance of serological assays for anti-HBs testing: Results from a quality assessment program.

Author information

1
Academic Collaborative Centre for Public Health AMPHI, Department of Primary and Community Care, Radboud University Nijmegen Medical Centre, The Netherlands; Department of Medical Microbiology, School of Public Health and Primary Care (CAPHRI), Maastricht University Medical Center (MUMC+), Maastricht, The Netherlands. Electronic address: Stijn.Raven@radboudumc.nl.
2
Academic Collaborative Centre for Public Health AMPHI, Department of Primary and Community Care, Radboud University Nijmegen Medical Centre, The Netherlands.
3
Centre for Infectious Disease Control, Netherlands Institute of Public Health and the Environment, Bilthoven, The Netherlands; Centre of Infectious Diseases, Leiden University Medical Centre, Leiden, The Netherlands.
4
MCA Laboratory, Queen Beatrix Hospital, Winterswijk, The Netherlands; On behalf of the Dutch Foundation for Quality Assessment in Medical Laboratories (SKML), The Netherlands.
5
Department of Sexual Health, Infectious Diseases and Environmental Health, South Limburg Public Health Service, The Netherlands; Department of Medical Microbiology, School of Public Health and Primary Care (CAPHRI), Maastricht University Medical Center (MUMC+), Maastricht, The Netherlands.
6
Department of Medical Microbiology, Leiden University Medical Centre, The Netherlands.

Abstract

BACKGROUND:

Post-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.

OBJECTIVES:

In this study we assess the performance of currently used anti-HBs assays.

STUDY DESIGN:

In 2013, 45 laboratories participated in an external quality assessment program using pooled anti-HBs serum samples around the cutoff values 10IU/l and 100IU/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.

RESULTS:

Different 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 10IU/l ranged from 93%-100% and was 44% for a cutoff value of 100IU/l.

CONCLUSIONS:

Around a cutoff value of 10IU/l use of the Access assay may result in false-negative results. Concerning the cutoff value of 100IU/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.

KEYWORDS:

Diagnostic test; Hepatitis B; Serology

PMID:
27987422
DOI:
10.1016/j.jcv.2016.12.002
[Indexed for MEDLINE]

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