Test ID: HAVM
Hepatitis A IgM Antibody, 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
Diagnosis of acute or recent hepatitis A infection
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, IgM
Anti-Hepatitis A IgM
Anti-Hepatitis A
HAA (Hepatitis A Antibody)
HAVABS IgM, Serum
Hepatitis A Antibody (Anti-HAV)
Hepatitis A IgM Ab, S
Hepatitis A Viral AB IgM, Serum
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: 1 mL
Collection Instructions: Spin down and remove serum from clot.
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 OK; 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.
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. Anti-HAV IgM becomes detectable in the blood within 2 weeks after infection, persisting at elevated levels for about 2 months before declining to undetectable levels by 6 months. However, sensitive immunoassays may occasionally detect anti-HAV IgM for up to 1 year after acute hepatitis A.
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
A positive result indicates acute or recent (<6 months) hepatitis A infection. As required by laws in almost all states, positive anti-hepatitis A virus (anti-HAV) IgM test results must be urgently reported to state health departments for epidemiologic investigations of possible outbreak transmission.
A negative result may indicate either 1) inadequate or delayed HAV IgM response after known exposure to HAV, or 2) absence of acute or recent hepatitis A.
Borderline anti-HAV IgM test results may be seen in: 1) early acute hepatitis A associated with rising antibody levels, 2) recent hepatitis A associated with declining levels, or 3) cross-reactivity with nonspecific antibodies (ie, false-positive results). Retesting of both anti-HAV IgM (HAVM Hepatitis A IgM Antibody, Serum) and anti-hepatitis A virus (anti-HAV) total (HAV Hepatitis A Total Antibodies, Serum) in 2 to 4 weeks 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
False-positive test results may be due to presence of cross-reactive antibodies from other viral infection or underlying illnesses. Positive results should be correlated with the patient’s clinical history and epidemiologic exposure.
Testing too early (<2 weeks) after exposure to hepatitis A virus (HAV) may yield negative anti-HAV IgM test results.
Not useful for determining presence of immunity to HAV infection from either past hepatitis A or vaccination against HAV.
Performance characteristics have not been established for the following specimen characteristics:
-Grossly icteric (total bilirubin level of >15 mg/dL)
-Grossly hemolyzed (hemoglobin level of >500 mg/dL)
-Grossly lipemic (triolein >3,000 mg/dL)
-Containing particulate matter
-Cadaveric specimens
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
An antibody class capture technique is used. This involves the dilution of the sample and the simultaneous reaction of IgM in the diluted sample with biotinylated mouse monoclonal antihuman IgM antibody. The immune complex is captured by streptavidin on the wells. Unbound materials are removed by washing. Horseradish peroxidase (HRP)-labeled mouse monoclonal anti-hepatitis A virus (anti-HAV) IgM, which has been complexed with recombinant HAV antigen (conjugate), is then captured by anti-HAV-specific IgM bound to the wells. Unbound material 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 IgM present in the sample. (Package insert: VITROS Anti-HAV IgM 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.
86709
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 |
|---|---|---|
| HAVM | Hepatitis A IgM Ab, S | 22314-9 |
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