Hepatitis A Antibody, IgM
Also known as: Anti-HAV, IgM, Antibody to Hepatitis A Virus, IgM, HAVAb, IgM
Use
This assay is intended for use as an aid in the diagnosis of acute or recent infection (usually 6 months or less) with hepatitis A virus (HAV). This is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to HAV. The presence of IgM antibody to HAV is diagnostic of acute HAV infection. To reduce false-positive tests, persons should only be tested for IgM anti-HAV if they are symptomatic and suspected of having HAV infection.
Special Instructions
This test may exhibit interference when the sample is collected from individuals consuming high-dose biotin supplements. It is advisable to inquire about biotin supplementation and recommend cessation of biotin intake at least 72 hours prior to sample collection.
Limitations
This assay is not cleared by the FDA for screening of blood or plasma donors. Performance characteristics are not established for immunocompromised or immunosuppressed patients, cord blood, patients under 2 years old, or cadaveric specimens. Anti-HAV tests might be positive after hepatitis A vaccination, but are usually not sensitive enough to detect low protective antibody levels post-vaccination.
Methodology
Immunoassay (CLIA)
Biomarkers
LOINC Codes
- 13950-1
- 13950-1
Result Turnaround Time
1-2 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
1 mL
Minimum Volume
0.4 mL
Container
Gel-barrier tube or serum transfer tube
Collection Instructions
Centrifuge sample within 24 hours of collection. If a gel-barrier tube is not used, or if the sample will be shipped frozen, transfer separated serum to a screw-cap polypropylene transport tube. Do not freeze gel-barrier tube (pour off serum first).
Patient Preparation
Patients should stop biotin consumption at least 72 hours prior to collection.
Storage Instructions
Room temperature
Causes for Rejection
Non-EDTA plasma specimen; PST gel-barrier tube; grossly hemolyzed specimens
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 14 days |
| Refrigerated | 14 days |
| Frozen | 14 days |