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New test: Hepatitis B Surface Antibody, Qualitative & Quantitative
Background:
The Microbiology Division will provide simultaneous qualitative and quantitative results for Hepatitis B surface antibody (anti-HBs). The test is indicated for assessing the response to Hepatitis B virus (HBV) vaccination, determination of HBV immune status and for the diagnosis of HBV infection when used in conjunction with clinical and other laboratory data. This assay does not distinguish between a vaccine-induced immune response and an immune response induced by infection with HBV. This test is not intended for use in screening blood, plasma or tissue donors. To monitor post-liver-transplant therapy with hepatitis B immunoglobulin in HBV-positive patients, please order XHBSAQ.

Effective date: Sept. 25, 2019

Methodology and reporting:
Specimens submitted for anti-HBs are tested using a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of antibody to hepatitis B surface antigen in blood. This assay on the Abbott Architect system provides both qualitative and quantitative results and will be reported as follows:

Qualitative results
  • Reactive. Patient should be considered immune to hepatitis B infection.
  • Equivocal. Recommend repeat testing in 2- 4 weeks.
  • Nonreactive
Quantitative results
Linear range: 8 – 1,000 mIU/mL. Results greater than 1,000 mIU/mL are reported as greater than 1,000 mIU/mL.

< 8.0 mIU/mL: Nonreactive
8.0 to 11.9 mIU/mL: Equivocal
= or > 12.0 mIU/mL: Reactive

Per assay manufacturer's instructions for use1, reactive results, defined as anti-HBs levels of 12 mIU/mL or greater, indicate adequate immunity against Hepatitis B virus (HBV) infection. However, per current CDC guidelines2,3, immunocompetent individuals with anti-HBs levels of 10 mIU/mL or greater after completing an HBV vaccination series are considered seroprotected.

Specimen requirements:
Collect: 4.0 mL blood in gold-top or red-top tube
Preparation: spin down and separate serum
Specimen required: 2.0 mL serum
Minimum volume: 1.0 mL serum

Test code: HBSABQ (Hepatitis B Surface Antibody, Qualitative/Quantitative)

Stability (after separation from cells):
Ambient: 3 days
Refrigerated: 7 days
Frozen: 1 year

Turnaround time (TAT): 1 – 4 days

Rejection criteria:
Specimens that exceed stated stability, unlabeled/mislabeled/mismatched specimens, specimens submitted in leaking containers, non-sterile containers, heparinized specimens. Any blood specimens shared with other test requests.

References: Click here ›

A summary of all tests offered by our laboratory services can be found here: http://www.pathology.uci.edu/services/index.asp

Sincerely,

Cassiana Bittencourt, MD
Director
Division of Clinical Microbiology

Edwin S. Monuki, MD, PhD
Chair
Department of Pathology & Laboratory Medicine
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