PREFERRED: Serum is the specimen of choice. Collect blood in a 4 ml Gold Serum Separator Tube-Clot Activator & Gel.
REMARK: Plasma IS NOT an acceptable alternative specimen for HAV IgG antibody testing.
4 ml of blood
2 ml of blood
A total of 2-4 ml of blood (for every 2-3 Hepatitis and HIV tests ordered) should be collected.
For the CHOP enterprise, submit blood specimens as soon as possible at room temperature to Central Laboratory Services.
For outside clients, it is recommended that sera be removed from the clot, red blood cells, or separator gel as soon as possible after collection and before shipping specimens. When shipping serum specimens, package and label specimens in compliance with applicable state, federal, and international regulations covering the transport of clinical specimens and infectious substances. Serum specimens may be shipped at 2-8C (wet ice) or frozen (dry ice). Do not exceed the storage time limitations listed under the heading of Stability.
Serum specimens should be stored for no longer than 3 days at room temperature or 7 days at 2-8C following specimen collection and separation from clot, red blood cells, or separator gel. If a storage period greater than 7 days is anticipated, serum should be stored frozen at -20C or colder. No more than 3 freeze-thaw cycles should be performed on any sample prior to testing, and specimens should not be stored in frost-free freezers.
Do not use serum specimens that are heat-inactivated, pooled, grossly hemolyzed, or contain obvious microbial contamination. Performance has not been established for the use of cadeveric specimens or the use of boody fluids other than human serum.
Unprocessed blood specimens should routinely be refrigerated at 4C upon arrival in the laboratory. One should remove the serum from clotted blood, red blood cells, or separator gel as soon as possible to avoid hemolysis. The best results are generally observed for serum specimens that are clear and nonhemolyzed. Lipemic, icteric, or hemolyzed specimens should be avoided when possible, and specimens with obvious microbial contamination should not be used. Specimens containing unremoved clots, red blood cells, or particulate matter may give inconsistent results and should be clarified by centrifugation before testing.
Monday thru Friday
Chemiluminescent microparticle immunoassay (CMIA)
This assay measures IgG-specific antibody responses to hepatitis A virus (HAV) infection. Anti-HAV IgG antibody is an indicator of recent or past infection with hepatitis A virus or seroconversion following immunization. If recent (acute) HAV infection is suspected, also order the hepatitis A virus (HAV) IgM antibody test. Testing of serum for anti-HAV IgG is used to determine the immune status of an individual, to assess a person's risk for traveling to an endemic region or working in a high-risk area, and to assist in making decisions to administer HAV vaccine or immune globulin prophylaxis following exposure to HAV.
This assay has not been FDA cleared or approved for the screening of blood or plasma donors.
S/CO < 1.00 NONREACTIVE - No detection of HAV IgG antibodies.
S/CO > or = 1.00 REACTIVE - Anti-HAV IgG antibodies detected.
After an acute infection, levels of anti-HAV IgG antibodies rise quickly and may persist for life. The presence of anti-HAV IgG antibody is indicative of either a past or present infection with hepatitis A virus or vaccination against HAV. A positive result for anti-HAV IgG in the absence of IgM anti-HAV indicates previous infection with HAV (or successful immunization) and protection against reinfection. Negative results for anti-HAV IgG are indicative of no evidence of infection with or vaccination against HAV. A negative result does not exclude early acute infection. If you suspect an acute HAV infection, please also order hepatitis A IgM testing. Recipients of intravenous immunoglobulin, newborn infants possessing pasively acquired maternal antibody, or patients who have received recent blood transfusions may be positive for IgG antibody to HAV. For diagnostic purposes, HAV IgG antibody reactivity should be correlated with patient history and other hepatitis markers for diagnosis of past or present infection, or vaccination against HAV.
S/CO < 1.00 NONREACTIVE for anti-HAV IgG antibodies.
As of 03/19/2013, a newly FDA-cleared anti-HAV IgG only assay is now being performed in the Clinical Virology Laboratory and has replaced the previously used anti-HAV total assay. The anti-HAV total antibody assay has been removed from the market and is no longer available in the United States.
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