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Louisiana Department of Health & Hospitals | Kathy Kliebert, Secretary

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Statewide Initiatives



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Hepatitis A IgM Antibody EIA

Hepatitis A IgM Antibody EIA

  • Laboratory Location – Central Laboratory
  • CPT Code – 86709
  • Synonyms – Antibody to Hepatitis A Virus IgM, Anti-HAV IgM
  • Test Description - The MONOLISA™ Anti-HAV IgM EIA is an enzyme immunoassay (IgM antibody capture format) for use in the qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human (adult and pediatric) serum. This assay is indicated for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis. Assay results, in conjunction with other serological or clinical information, may be used for the laboratory diagnosis of individuals with acute or recent hepatitis A.

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 - 220 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

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
  • Hyperhemolyzed, contaminated and/or hyperlipemic specimens
  • 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

Diagnosis of an infectious disease should not be established on the basis of a single test result. Detection of anti-HAV IgM does not necessarily imply an acute HAV infection due to the longevity of anti-HAV IgM. The detection of anti-HAV IgM can be useful for the differential diagnosis of hepatitis A from other forms of viral hepatitis. Any diagnosis should take into consideration the patient's clinical history and symptoms, as well as other laboratory data. Patients with specimens exhibiting borderline results should be retested at approximately two week intervals. A reactive anti-HAV IgM result does not exclude co-infection by another hepatitis virus. A non-reactive result does not exclude the possibility of infection with hepatitis A virus. Levels of Anti-HAV IgM may be below the cutoff in early infection. The performancce of the MONOLISA™ Anti-HAV IgM EIA has not been established with immunosuppressed or immunocompromised patients, cord blood, neonatal specimens, cadaveric specimens, heat-inactivated specimens, or body fluids other than serum or plasma, such as saliva, urine, amniotic, or pleural fluids.

Interfering Substances

  • Heterophilic antibodies
  • Bacterial contamination
  • hyperhemolysis
  • hyperlipemia

References

  • BioRad MONOLISA™ ANti-HAV IgM EIA package insert
  • EVOLISTM Operator Manual

 

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