PREFERRED: Serum is the preferred specimen. Collect blood in a 4 ml Gold Serum Separator Tube-Clot Activator & Gel.
REMARK: Plasma is an acceptable alternative specimen. Blood can be collected in plastic tubes containing dipotassium EDTA (preferred) with or without gel separator, lithium heparin with gel separator, or sodium heparin.
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 serum or plasma specimens be removed from the clot, red blood cells, or separator gel as soon as possible after collection and before shipping specimens. When shipping serum or plasma specimens, package and label specimens in compliance with applicable state, federal, and international regulations covering the transport of clinical specimens and infectious substances. 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 or plasma 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 or plasma 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 or plasma 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 or plasma.
Unprocessed blood specimens should routinely be refrigerated at 4C upon arrival in the laboratory. One should remove the serum or plasma from clotted blood, red blood cells, or separator gel as soon as possible to avoid hemolysis. The best results are generally observed for serum or plasma 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)
Indicator of recent acute infection with Hepatitis A virus (HAV). IgM-specific antibody to HAV is present from the onset of symptoms and declines to nondetectable levels within 3-6 months in most individuals. Low levels of anti-HAV IgM may persist for more than 1 year in some patients.
S/CO < 0.80 NONREACTIVE - Anti-HAV IgM not detected. Does not exclude the possibility of exposure to or infection with HAV. Levels of anti-HAV IgM may be below the cut-off in early infection.
S/CO 0.80 to < 1.21 - Grayzone for anti-HAV IgG antibodies detected. Anti-HAV IgM antibodies may or may not be present. Patients exhibiting grayzone test results should be closely monitored by retesting at approximately one week intervals. Monitoring the level of IgM anti-HAV by retesting at one week intervals will distinguish rapidly rising anti-HAV IgM levels associated with early acute hepatitis A virus infection from gradually decreasing or unchanging anti-HAV IgM levels often associated with the late acute stage of HAV infection.
S/CO > or = 1.21 REACTIVE - Anti-HAV IgG antibodies detected. Presumptive evidence of HAV infection. A reactive anti-HAV IgM result does not necessarily rule out other hepatitis infections.
The presence of HAV IgM antibody is indicative of a recent acute infection with HAV in persons with signs and symptoms of hepatitis and in persons at risk for HAV infection. Negative results are indicative of no evidence of a recent acute infection with HAV. Does not exclude early acute infection or past infection with HAV. If you suspect a past HAV infection or are attempting to determine the immune status of an individual following vaccination, please also order anti-HAV IgG antibody testing. For diagnostic purposes, anti-HAV IgM reactivity should be correlated with patient history and other hepatitis markers for diagnosis of past or present infection, or vaccination against HAV.
S/CO < 0.80 NONREACTIVE for IgM antibody to hepatitis A virus.
As of 03/19/2013, the anti-HAV IgM assay will be performed on the Abbott ARCHITECT automated immunoassay instrument and replaces the anti-HAV IgM assay previously performed on the Abbott AxSym automated platform. The AxSym instrument and corresponding anti-HAV IgM antibody assay have been removed from the market and are no longer available in the United States. Results obtained for the HAV IgM assay on the ARCHITECT are comparable to those observed when usiing the AxSym-based HAV IgM assay.
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