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

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

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.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Hepatitis B / diagnosis*
  • Hepatitis B Surface Antigens / blood*
  • Hepatitis B Vaccines / administration & dosage
  • Hepatitis B Vaccines / immunology*
  • Humans
  • Immunoassay / methods*
  • Laboratory Proficiency Testing
  • Quality Assurance, Health Care*
  • Sensitivity and Specificity
  • Serologic Tests / methods*

Substances

  • Hepatitis B Surface Antigens
  • Hepatitis B Vaccines