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HBsAg confirmation: an experimental test.

M Orgel1, A Yaari, B Sarov

  • 1Department of Epidemiology, Ben-Gurion University of the Negev, POB 653, Beer-Sheva 84105, Israel.

Clinical and Diagnostic Virology
|August 1, 1996
PubMed
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This study validates a new antibody (HrAb) for Hepatitis B surface antigen (HBsAg) confirmation, showing it effectively reduces false positives in blood serum samples.

Area of Science:

  • Hepatitis B diagnostics
  • Immunoserology
  • Viral marker detection

Background:

  • Hepatitis B surface antigen (HBsAg) testing requires confirmation to prevent false positive results.
  • Antibody blocking is a key method for verifying HBsAg test specificity.

Purpose of the Study:

  • To evaluate the HBsAg-blocking efficacy of an experimental antibody, HrAb.
  • To assess HrAb's utility in confirming repeatedly reactive HBsAg blood serum samples.

Main Methods:

  • Comparative confirmatory testing of HBsAg screening using commercial HuAb and experimental HrAb.
  • Utilizing HrAb in subsequent HBsAg confirmation trials on quality control panels and patient samples.

Main Results:

  • HrAb demonstrated good agreement with HuAb in HBsAg confirmation, irrespective of the neutralization method.

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  • Of 97 repeatedly reactive samples, 79 were confirmed positives. Further testing with both antibodies converted 13/18 initially unconfirmed samples to confirmed positives, with five remaining false positives.
  • Conclusions:

    • The experimental HrAb is comparable to the commercial HuAb for HBsAg confirmation.
    • HBsAg confirmatory testing is crucial for accurately interpreting repeatedly reactive samples in laboratory diagnostics.