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Louisiana Department of Health & Hospitals | Kathy Kliebert, Secretary

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Hepatitis A IgG and IgM Antibody EIA

Hepatitis A IgG and IgM Antibody EIA

  • Laboratory Location – Central Laboratory
  • CPT Code – 86709: Hepatitis A Virus IgM, 86708: Hepatitis A Virus IgG
  • Synonyms – Total Antibodies to Hepatitis A Virus, Anti-HAV Total (IgG and IgM)
  • Test Description - The MONOLISA™ Anti-HAV EIA is an in vitro enzyme immunoassay for use in the qualitative detection of total antibodies (IgG and IgM) to hepatitis A virus (anti-HAV) in human (adult and pediatric) serum. This assay is indicated as an aid in the diagnosis of acute or past hepatitis A virus (HAV) infection or as an aid in identification of HAV-susceptible individuals for vaccination.

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 - 250 μLserum (does not allow for repeat testing)

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. Any diagnosis should take into consideration the patient's clinical history and symptoms, as well as other laboratory data. The assay calibrator is equivalent to 20 mIU/mL standardized to the WHO 2nd Reference Standard for Anti-hepatitis Immunoglobin. However, assay results cannot be considered quantitative and no clinical claims for immunity can be determined from the cutoff. A reactive anti-HAV result does not exclude co-infection by another hepatitis virus. The non-reactive result does not exclude the possibility of infection with hepatitis A virus. Levels of Anti-HAV 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. The performance of the MONOLISA™ Anti-HAV EIA detects both anti-HAV IgG and IgM antibodies. However, assays detecting total antibodies are known to be more sensitive for anti-IgG than IgM.

Interfering Substances

  • Heterophilic antibodies
  • Bacterial contamination
  • hyperhemolysis
  • hyperlipemia

References

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

 

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