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Efficient implementation of hepatitis B surface antigen confirmatory neutralization tests.

Hitoshi Yonezawa1, Shingo Tanaka2, Makito Tanaka3

  • 1Division of Laboratory Medicine, Sapporo Medical University Hospital, Sapporo, Japan.

Journal of Infection and Chemotherapy : Official Journal of the Japan Society of Chemotherapy
|September 10, 2023
PubMed
Summary

False positives in hepatitis B surface antigen (HBsAg) tests are common in low-value ranges. Younger age, female sex, and lower HBsAg levels are key risk factors, necessitating targeted neutralization tests.

Keywords:
Confirmatory neutralization testHepatitis B surface antigenHepatitis B virusHigh-sensitivity hepatitis B surface antigen quantitative test

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Area of Science:

  • Hepatology
  • Clinical Chemistry
  • Diagnostic Immunology

Background:

  • Hepatitis B surface antigen (HBsAg) assays require confirmation for low-positive results to prevent false positives.
  • Neutralization tests are recommended but often not implemented due to cost.
  • Identifying risk factors for false positives can optimize the use of confirmatory testing.

Purpose of the Study:

  • To identify risk factors associated with false positives in high-sensitivity HBsAg quantitative tests.
  • To reduce the need for unnecessary neutralization tests by targeting high-risk cases.

Main Methods:

  • Retrospective cohort study analyzing 47,305 patients with HBsAg measurements.
  • Included patients with HBsAg values between 0.005 and 1.000 IU/mL undergoing neutralization tests.
  • Multivariate analysis to determine independent risk factors for false positives.

Main Results:

  • Out of 329 patients included, 57 (17%) showed false-positive HBsAg results confirmed by neutralization tests.
  • Independent risk factors for false positives included younger age (aOR 6.57), female sex (aOR 2.32), and lower HBsAg values (aOR 59.6).
  • False-positive rates were 33.1% for HBsAg 0.005-0.049 IU/mL and 1.2% for >0.050 IU/mL.

Conclusions:

  • Confirmatory neutralization tests are crucial for HBsAg values in the 0.005-0.049 IU/mL range.
  • Targeting neutralization tests based on identified risk factors can improve diagnostic accuracy.
  • Optimizing HBsAg testing strategies can enhance patient care and resource allocation.