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.
1 - 2 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Serum or plasma
1 mL
0.4 mL (Note: This volume does not allow for repeat testing.)
Red-top tube, gel-barrier tube, or lavender-top (EDTA) tube
If tube other than a gel-barrier tube is used, transfer separated serum or plasma to a plastic transport tube.
Room temperature
Temperature
Period
14 days
Refrigerated
Frozen
Freeze/thaw cycles
Stable x3
Non-EDTA plasma specimen; PST gel-barrier tube; grossly hemolyzed specimens
This anti-HAV assay is indicated as an aid in the diagnosis of previous or ongoing hepatitis A viral infection or in the identification of HAV-susceptible individuals for vaccination. This assay is an in vitro diagnostic immunoassay for the qualitative determination of total antibodies to hepatitis A virus (anti-HAV) in human neonatal, pediatric, and adult specimens. This assay measures both IgG and IgM antibodies, but does not differentiate between them.
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.
Immunochemiluminometric assay (ICMA)
Negative
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 develops within a week of symptom onset, peaks around three months, and is usually no longer detectable after six months. Many cases of hepatitis A are subclinical, particularly in children. Antibody produced in response to HAV infection (anti-HAV) 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 current from previous 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.
