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Louisiana Department of Health & Hospitals | Kathy Kliebert, Secretary

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Hepatitis B Surface Antibody EIA

Hepatitis B Surface Anitbody EIA

  • Laboratory Location – Central Laboratory
  • CPT Code – 86706
  • Synonyms – Antibody to Hepatitis B Surface Antigen, Anti-HBs
  • Test Description - The Bio-Rad MONOLISA™ Anti-HBs EIA is used for the detection of antibody to hepatitis B surface antigen in human serum. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboartory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in which etiology is unknown.

Possible Results

  • Non-Reactive
  • Borderline
  • Reactive

Reference Range

  • Reactive

Specimen Requirements

  • Specimen Type - Serum
  • Specimen Container(s) - red top tubes, Marble top tubes, polypropylene vials
  • Minumum accepted volume - 275 μL

Specimen Collection Instructions

Blood should be collected in a plastic, sterile STD Program approved collection tube. Please follow the manufacturer's instructions on clot time and centrifuge speed/time requirements.

The Virology Lab 96 form must be filled out completely. The following information must be included on the form:

  • Patient's Name
  • Patient's Date of Birth
  • Patient's Gender
  • Date and time of specimen collection
  • Test requested
  • Type of specimen collected
  • Submitter's name and address

Storage and Transport Instructions

Speciments should be shipped refrigerated (2-8ºC) within 7 days of collection. For longer storage, specimens must be frozen at -20ºC or colder. Frozen specimens must be shipped on dry ice and received at a temperature of -20ºC or colder.

Causes for Rejection

  • expired collection tubes
  • incorrect specimen type
  • unspun samples
  • tubes that contain less than 90% of the total drawing capacity (QNS)
  • Improper storage or improper transport temperature requirements are also reasons for rejection

Limitations for the Procedure

For diagnostic purposes, results should be used in conjunction with patient history and other hepatitis markers for diagnosis of acute and chronic infection. A non-reactive test result does not exclude the possibility of exposure to hepatitis B virus. Results obtained with the MONOLISA™ Anti-HBs EIA assay may not be used interchangeably with values obtained with different manufacturers' anti-HBs assay methods. Results from immuosuppressed patients should be interpreted with caution. This assay does not differentiate between a vaccine-induced immune response and an immune response induced by infection with HBV. To determine if the anti-HBs response is due to vaccine or HBV infection, a total anti-HBc assay may be performed. Performance characteristics have not been established for therapeutic monitoring. A reactive anti-HBs result does not exclude co-infection by another hepatitis virus. Individuals that have received blood component therapy (e.g., whole blood, plasma, immune globulin administration) during the previous 3 to 6 months may have a false reactive anti-HBs result due to passive transfer of anti-HBs. The performance of the MONOLISA™ ANti-HBs EIA has not been establised with cord blood, neonatal specimens, cadaver specimens, heat-inactivated specimens, or body fluids other than serum or plasma, such as saliva, urine, amniotic, or pleural fluids. 

Interfering Substances

  • None listed in the package insert

References

  • BioRad MONOLISA™ Anti-HBs EIA package insert
  • EVOLISTM Operator Manual

 

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