Test Catalog

Test Id : HAVTA

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Hepatitis A Virus Total Antibodies, Serum

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Overview

Test Catalog

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

Detection of recent or previous exposure or immunity to hepatitis A.

 

This test should not be used as a screening or confirmatory test for blood or solid or soft tissue donor specimens.

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.

No

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

Hepatitis A Virus Total Ab, S

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

Anti-HAV (Hepatitis A Virus)

Anti-HAV IgG and IgM

Anti-HAV Total Antibodies

Anti-Hepatitis A

HAA (Hepatitis A Antibody)

HAVAB IgG+IgM, Serum

Hepatitis A Ab, P

Hepatitis A Antibody (Anti-HAV)

Hepatitis A Viral AB IgG+IgM, Serum

Hepatitis A Viral Antibody, Plasma

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 (red-top tubes are not acceptable)

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 forms with the specimen:

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. The minimum volume is sufficient for one attempt at testing.

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

Detection of recent or previous exposure or immunity to hepatitis A.

 

This test should not be used as a screening or confirmatory test for blood or solid or soft tissue donor specimens.

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, however, in areas of poor hygiene and low socioeconomic conditions. The virus is transmitted primarily by the fecal-oral route, and it is spread by close person-to-person contact and by food- and water-borne epidemics. Outbreaks frequently occur in overcrowded situations and in high-density institutions and centers, such as prisons and health care or day care 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.

 

In most cases, HAV-specific antibodies (anti-HAV) are detectable by the time that symptoms occur, usually 15 to 45 days after exposure. Initial antibodies consist almost entirely of the IgM subclass. Anti-HAV IgM usually falls to an undetectable level by 6 months after HAV infection. Anti-HAV IgG levels rise quickly once the virus is cleared and may persist for many years. Currently, commercial diagnostic assays are available for detecting anti-HAV IgM alone (HAIGM / Hepatitis A IgM Antibody, Serum) or anti-HAV total (IgM and IgG) but not anti-HAV IgG alone.

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.

Unvaccinated: Negative

Vaccinated: Positive

Interpretation
Provides information to assist in interpretation of the test results

This assay detects the presence of hepatitis A virus (HAV)-specific total antibodies (both anti-HAV IgG and anti-HAV IgM combined). A positive result indicates that the patient had hepatitis A either recently or in the past or immunity to hepatitis A from vaccination. A reactive (positive) result by the Elecsys Anti-HAV II assay does not differentiate between acute or past HAV infection or immunity from vaccination, and it does not necessarily rule out other hepatitis infections.

 

If clinically indicated, specific testing for anti-HAV IgM is necessary to confirm the presence of acute or recent hepatitis A. A positive result for anti-HAV total with a negative anti-HAV IgM result indicates immunity to hepatitis A from either past HAV infection or vaccination against HAV.

 

A negative result indicates the absence of recent or past hepatitis A or a lack of immunity to HAV infection. A non-reactive (negative) test result does not exclude the possibility of early acute infection with HAV.

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

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination, and other findings.

 

In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur. Passively acquired antibody (eg, recent immune globulin administration, transfusion) may result in transiently positive test results.

 

Serum specimens from individuals taking biotin supplements at 20 mg or more per day may have false-positive anti-HAV (hepatitis A virus) total Ab test results due to interference of biotin with the assay. Such individuals should stop taking these biotin-containing dietary supplements for a minimum 12 hours before blood collection for this test.

 

Regardless of exposure history, testing for anti-HAV total antibdies alone is insufficient to confirm a diagnosis of acute hepatitis A.

 

Assay performance characteristics have not been established for immunosuppressed individuals or those under 2 years of age.

 

Assay performance characteristics have not been established for the following specimen characteristics or specimen types:

-Grossly icteric (total bilirubin level of >66 mg/dL)

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

-Grossly lipemic (intralipid >2000 mg/dL)

-Containing particulate matter

-Cadaveric specimens

-Specimen types other than serum

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. Prasidthrathsint K, Stapleton JT.  Laboratory diagnosis and monitoring of viral hepatitis. Gastroenterol Clin North Am. 2019;48(2)259-279. Available at www.ncbi.nlm.nih.gov/pmc/articles/PMC10461253/

3. Centers for Disease Control and Prevention. Prevention of hepatitis A virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices, 2020. Mort Morbid Wkly Rpt; 2020;69(5):1-38. doi:10.15585/mmwr.rr6905a1

4. van Damme P, Pinto RM, Feng Z, et al. Hepatitis A virus infection. Nature Rev Dis Primers. 2023;9:51. doi:10.1038/s41572-023-00461-2

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

Elecsys Anti-HAV II assay is performed using an electrochemiluminescence immunoassay on the automated cobas e 801 immunochemistry analyzer. Hepatitis A virus (HAV) antibodies in the patient’s serum binds with added HAV antigen. After addition of biotinylated monoclonal anti-HAV and streptavidin-coated microparticles, the patient’s anti-HAV 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 emission that is measured by a photomultiplier. Test result for each patient’s sample is determined automatically by the assay-specific software program by comparing the electrochemiluminescence signal generated from the patient’s sample to the signal cutoff index value set from reagent lot-specific assay calibrations.(Package insert: Elecsys Anti-HAV II. Doc. 08086664190, v3.0; 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 Friday, Sunday

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.

Same day/1 to 3 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

Jacksonville

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.

86708

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
HAVTA Hepatitis A Virus Total Ab, S 13951-9
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.
HAVT Hepatitis A Virus Total Ab, S 13951-9

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 | 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

Test Update Resources

Change Type Effective Date
New Test 2024-04-18
New Test 2024-04-18