Test ID: HAV
Hepatitis A Total Antibodies, Serum
NY State Approved 
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Detection of recent or previous exposure or immunity to hepatitis A
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Method Name A short description of the method used to perform the test
Chemiluminescence Immunoassay
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
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 needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 2 mL
Collection Instructions: Spin down and remove serum from gel within 24 hours.
Additional Information: Date of draw is required.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild reject; Gross reject |
| Lipemia | Mild OK; Gross reject |
| Icterus | Mild OK; Gross reject |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum SST | Frozen (preferred) | |
| Refrigerated | 7 days | |
| Ambient | 24 hours | |
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, 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 only anti-HAV IgM (HAVM Hepatitis A IgM Antibody, Serum or anti-HAV Total, 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.
Negative
See Viral Hepatitis Serologic Profiles in Special Instructions.
Interpretation Provides information to assist in interpretation of the test results
This assay detects the presence of anti-HAV total (both IgG and IgM combined). A positive result indicates that the patient had hepatitis A either recently or in the past.
If clinically indicated, specific testing for anti-HAV IgM (HAVM Hepatitis A IgM Antibody, Serum) is necessary to confirm the presence of acute or recent hepatitis A. A positive result for anti-HAV total (HAV Hepatitis A Total Antibodies, Serum) with a negative anti-HAV IgM (HAVM Hepatitis A IgM Antibody, Serum) 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.
Borderline test results for anti-HAV total may be seen in: 1) acute hepatitis A with rising levels of anti-HAV IgM, 2) recent hepatitis with rising levels of anti-HAV IgG, or 3) cross-reactivity with nonspecific antibodies (ie, false-positive results). Retesting of both anti-HAV total (HAV Hepatitis A Total Antibodies, Serum) and anti-HAV IgM (HAVM Hepatitis A IgM Antibody, Serum) is recommended to determine the definitive HAV infection status.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Passively acquired antibody (eg, recent immune globulin administration, transfusion) may result in transiently positive test results.
Regardless of exposure history, testing for anti-hepatitis A virus total alone is insufficient to detect acute hepatitis A.
Performance characteristics have not been established for the following specimen characteristics:
-Grossly icteric (total bilirubin level of >20 mg/dL)
-Grossly hemolyzed (hemoglobin level of >125 mg/dL)
-Grossly lipemic (triolein >3,000 mg/dL)
-Containing particulate matter
-Cadaveric specimens
-Immunocompromised or immunosuppressed
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Wasley A, Fiore A, Bell BP: Hepatitis A in the era of vaccination. Epidemiol Rev 2006;28:101-111
2. Nainan OV, Xia G, Vaughan G, Margolis HS: Diagnosis of hepatitis A infection: a molecular approach. Clin Microbiol Rev 2006;19:63-79
Method Description Describes how the test is performed and provides a method-specific reference
The VITROS anti-hepatitis A virus (anti-HAV) total assay is a competitive immunoassay method based on the preincubation of anti-HAV total in the sample with HAV antigen in the assay reagent, followed by incubation with horseradish peroxidase (HRP)-labeled antibody conjugate (mouse monoclonal anti-HAV). The immune complex is captured by streptavidin on the well surface. Unbound conjugate is removed by washing.
The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The light signals are read by the VITROS ECi system. The amount of HRP conjugate is indicative of the concentration of anti-HAV present in the sample. (Package insert: VITROS Anti-HAV Total Reagent Pack, no. GEM1235A, version 3.0, Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626-5101, 8/18/2009)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Saturday; Varies
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
86708
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| HAV | Hepatitis A Total Ab, S | 20575-7 |
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