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Louisiana Department of Health & Hospitals | Kathy Kliebert, Secretary

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IgM Antibody to Hepatitis B Core Antigen EIA

IgM Antibody to Hepatitis B Core Antigen EIA

  • Laboratory Location – Central Laboratory
  • CPT Code – 86705
  • Synonyms – Anti-HBc IgM
  • Test Description - The MONOLISA™ Anti-HBc IgM EIA is an enzyme immunoassay intended for use in the qualitative detection of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum. Assay results may be used with other HBV serologic markers for the laboratory diagnosis of HBV disease associated with HBV infection.

Possible Results

  • Non-Reactive
  • Borderline
  • Reactive

Reference Range

  • Non-Reactive

Specimen Requirements

  • Specimen Type - Serum
  • Specimen Container(s) - red top tubes, Marble top tubes, polypropylene vials
  • Minumum accepted volume - 210 μL serum

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

Specimens should be shipped refrigerated (2-8ºC) within 48 hours 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

A non-reactive test result does not exclude the possibility of exposure to hepatitis B virus. Results from immunosuppressed patients should be interpreted with caution. A reactive anti-HBc IgM result does not exclude co-infection by another hepatitis virus. The performance of the BioRad MONOLISA™ Anti-HBc EIA has not been established with cord blood, neonatal specimens, cadaver specimens, or body fluids other than serum or plasma, such as saliva, urine, amniotic, or pleural fluids.

Interfering Substances

  • No clinically significant effect has been detected in assay results with increased levels of protein, lipids, bilirubin, or hemoglobin.

References

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

 

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