Test Catalog

Test Id : HAIGM

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Hepatitis A Virus IgM Antibody, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Diagnosis of acute or recent hepatitis A infection

Method Name
A short description of the method used to perform the test

Electrochemiluminescence Immunoassay (ECLIA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Hepatitis A IgM Ab, S

Aliases
Lists additional common names for a test, as an aid in searching

Anti-HAV

Anti-HAV IgM

Anti-Hepatitis A

Anti-Hepatitis A IgM

HAVAB-M

Hepatitis A antibody

Hepatitis A IgM antibody

Hepatitis A IgM

HAIGM

Specimen Type
Describes the specimen type validated for testing

Serum SST

Necessary Information

Date of collection is required.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Patient Preparation: For 24 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).

Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 0.6 mL

Collection Instructions:

1. Centrifuge blood collection tube per manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot serum into plastic vial.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

If not ordering electronically, complete, print, and send 1 of the following:

-Gastroenterology and Hepatology Test Request (T728)

-Infectious Disease Serology Test Request (T916)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.6 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 90 days
Refrigerated 6 days
Ambient 72 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

Diagnosis of acute or recent hepatitis A infection

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Hepatitis A virus (HAV) is endemic throughout the world, occurring most commonly in areas of poor hygiene and low socioeconomic conditions. The virus is transmitted primarily by the fecal-oral route and spread by close person-to-person contact and by food and waterborne epidemics. Outbreaks frequently occur in overcrowded situations and high-density institutions and centers, such as prisons and healthcare or daycare centers. Viral spread by parenteral routes (eg, exposure to blood) is possible, but rare, because infected individuals are viremic for a short period of time (usually <3 weeks). There is little or no evidence of transplacental transmission from mother to fetus or transmission to newborn during delivery.

 

Serological diagnosis of acute viral hepatitis A depends on the detection of specific anti-HAV IgM. Its presence in the patient's serum indicates a recent exposure to HAV. HAV-specific IgM antibody level becomes detectable in the blood by 4 weeks after infection, persisting at elevated levels for about 2 months before declining to undetectable levels by 6 months. They rarely persist beyond 12 months after infection.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Interpretation
Provides information to assist in interpretation of the test results

This assay detects the presence of hepatitis A virus (HAV)-specific IgM antibody in serum.

 

Negative results indicate either inadequate or delayed anti-HAV IgM response after known exposure to HAV or absence of acute or recent hepatitis A.

 

Equivocal results may be seen in early acute hepatitis A associated with rising anti-HAV IgM levels or recent hepatitis A infection associated with declining anti-HAV IgM levels. Retesting for both anti-HAV IgM (HAIGM / Hepatitis A Virus IgM Antibody, Serum) and anti-HAV Total (HAVTA / Hepatitis A Virus Total Antibodies, Serum) in 2 to 4 weeks is recommended to determine the definitive HAV infection status.

 

Positive results indicate acute or recent (<6 months) hepatitis A infection. As required by laws in almost all states, positive anti-HAV IgM test results must be urgently reported to state health departments for epidemiologic investigations of possible outbreak transmission.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Testing too early (<2 weeks) after exposure to hepatitis A virus (HAV) may yield negative anti-HAV IgM results.

 

False-positive results may be due to presence of cross-reactive antibodies from other viral infection or underlying illnesses (such as non-Hodgkin lymphoma). Positive results should be correlated with patient's clinical history and epidemiologic exposure.

 

The presence of heterophilic antibodies and human antimouse antibodies (in patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy) in serum may interfere with the assay and cause erroneous results (false-positive or false-negative).

 

Consumption of high-dose biotin supplement within 12 hours of blood collection for this test can cause false-negative test results. Individuals should cease taking these biotin-containing dietary supplements for minimum 12 hours before blood collection for this test.

 

Performance characteristics have not been established for the following specimen characteristics:

-Grossly icteric (total bilirubin level of >50 mg/dL)

-Grossly hemolyzed (hemoglobin level of >1000 mg/dL)

-Grossly lipemic (intralipid >2000 mg/dL)

-Containing particulate matter

-Heat-inactivated

-Cadaveric specimens

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. de Paula VS. Laboratory diagnosis of hepatitis A. Future Virology. 2012;7(5):461-472

2. Nelson NP, Weng MK, Hofmeister MG, et al. Prevention of hepatitis A infection in the United States: Recommendations of the Advisory Committee on Immunization Practices, 2020. MMWR Morb Mortal Wkly Rep. 2020;69(5):1-38. Erratum in MMWR Morb Mortal Wkly Rep. 2021;70(8):294

3. Webb GW, Kelly S, Dalton HR. Hepatitis A and hepatitis E: clinical and epidemiological features, diagnosis, treatment, and prevention. Clin Microbiol Newslett. 2020;42(21):171-179

Method Description
Describes how the test is performed and provides a method-specific reference

The Elecsys Anti-HAV (hepatitis A virus) IgM assay is based on the sandwich immunoassay principle and performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. HAV-specific IgM antibody (anti-HAV IgM) in the patient’s serum sample is pretreated with anti-Fdy reagent to block specific IgG in the presence of monoclonal anti-HAV antibodies labeled with ruthenium complex. After addition of biotinylated monoclonal human-IgM-specific antibodies, HAV antigen, and streptavidin-coated microparticles, patient’s anti-HAV IgM form a sandwich complex with the HAV antigen and the ruthenium-labeled anti-HAV antibody which becomes bound to the solid phase via interaction of biotin and streptavidin. The reaction mixture is then aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode, and unbound substances are washed away. Voltage is applied to the electrode then induces chemiluminescent emissions that are measured by a photomultiplier. Test result is determined automatically by the assay-specific software program by comparing the electrochemiluminescence signal generated from the patient’s sample to the cutoff index value set from reagent lot-specific assay calibration.(Package insert: Elecsys Anti-HAV IgM. Roche Diagnostics; v5.0, 11/2022)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 2 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86709

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
HAIGM Hepatitis A IgM Ab, S 13950-1
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
HAIGM Hepatitis A IgM Ab, S 13950-1

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | PHP Pdf | CMS Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports