Hep B core Antibody IgM
(Specimen Container)
SST (Tiger Top) Lithium Heparin/ Sodium Heparin/ Dipotassium EDTA
(Transport Temperature)
| Temperature | Period |
|---|---|
| Room temperature | 72 hours |
| Refrigerated | 7 days |
| Frozen | If delayed longer than the max RT or 2-8°C, store frozen |
Virus specific IgM antibody has been detected in most acute viral infections and is a reliable marker for acute viral disease. High levels of IgM anti-HBc have been detected in patients with acute HBV infection and low levels have been detected in some patients with chronic HBV infection. Differentiation of acute and chronic HBV infection on the basis of viral markers such as HBsAg, anti-HBs, HBeAg, anti-HBe, and anti-HBc is difficult because most of these markers are seen during both acute and chronic disease. In cases where these markers are present, acute illness with other agents such as hepatitis C, non-A, non-B, non-C hepatitis, and delta hepatitis may confuse the diagnosis. Several studies have demonstrated that IgM anti-HBc is the only specific marker for the diagnosis of acute HBV infection
The Alinity i Anti-HBc IgM assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgM antibody to hepatitis B core antigen (IgM anti-HBc) in human adult and pediatric serum or plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum on the Alinity i analyzer.
The Alinity i Anti-HBc IgM assay is to be used as an aid in the diagnosis of acute or recent hepatitis B virus (HBV) infection in conjunction with other laboratory results and clinical information.
WARNING: Not intended for use in screening blood, plasma or tissue donors. The effectiveness of the Alinity i Anti-HBc IgM assay for use in screening blood, plasma, or tissue donors has not been established.
Assay performance characteristics have not been established when the Alinity i Anti-HBc IgM assay is used in conjunction with other manufacturers’ assays for specific hepatitis markers. Users are responsible for establishing their own performance characteristics.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. The user is responsible for establishing their own assay performance characteristics in these populations.
No quantitative reference range
