Test Details
Methodology
Immunochemiluminometric assay (ICMA)
Result Turnaround Time
1 - 2 days
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 sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.
Specimen Requirements
Limitations
This assay has not been FDA cleared or approved for the screening of blood or plasma donors. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, or patients less than 2 years of age.
References
Custom Additional Information
Hepatitis A virus (HAV) is a picornavirus primarily transmitted via the fecal-oral route. HAV replicates in the liver and is shed in high concentrations in feces from 2-3 weeks before to 1 week after the onset of clinical illness. IgM antibody typically becomes detectable within 5-10 days of the onset of symptoms, usually peaks within 1 month of illness, and decreases to undetectable levels within 6 months of infection. Many cases of HAV are subclinical, particularly in children. Antibody produced in response to HAV infection persists for life and confers protection against reinfection. The presence of IgM antibody to HAV is diagnostic of acute HAV infection. A positive test for total anti-HAV indicates immunity to HAV infection but does not differentiate active from resolved HAV infection. Although usually not sensitive enough to detect the low level of protective antibody after vaccination, anti-HAV tests also might be positive after hepatitis A vaccination.
Specimen
Serum or plasma
Volume
1 mL
Minimum Volume
0.4 mL (Note: This volume does not allow for repeat testing.)
Container
Red-top tube, gel-barrier tube, or lavender-top (EDTA) tube
Storage Instructions
Room temperature
Causes for Rejection
Non-EDTA plasma specimen; PST gel-barrier tube; grossly hemolyzed specimens
Collection Instructions
If tube other than a gel-barrier tube is used, transfer separated serum or plasma to a plastic transport tube.
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 14 days |
Refrigerated | 14 days |
Frozen | 14 days |
Freeze/thaw cycles | Stable x3 |
Reference Range
Negative
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 006734 | Hep A Ab, IgM | 13950-1 | 006734 | Hep A Ab, IgM | 13950-1 | |
| Order Code | 006734 | |||||
| Order Code Name | Hep A Ab, IgM | |||||
| Order Loinc | 13950-1 | |||||
| Result Code | 006734 | |||||
| Result Code Name | Hep A Ab, IgM | |||||
| UofM | ||||||
| Result LOINC | 13950-1 |