| Synonym(s): | Enzyme Immunoassay (EIA) for the Detection of Antibodies to Hepatitis B Core IgM in Human Serum Specimens |
| Requisition Form | G-2A |
| Test Description | An enzyme immunoassay (EDIA) for the qualitative detection of IgM Antibodies to hepatitis B core antigen in human serum |
| Pre-Approval Needed | N/A |
| Supplemental Information Required | N/A |
| Supplemental Form(s) | N/A |
| Performed on Specimens from (sources) | Human |
| Sample/Specimen Type for Testing | Serum |
| Minimum Volume/Size Required | 500 µL |
| Storage/Preservation Prior to Shipping | Serum may separated from the clot may be stored at 2°C to 8°C up to 48 hours, but then must be frozen at -20°C or colder till tested. |
| Transport Medium | N/A |
| Specimen Labeling | - At least 2 specific identifiers: First and last name as one identifier and a DOB or a unique patient specific identifier (e.g. Medical Record number); must match information on submission form(G2-A)
- Identifiers on specimen must exactly match submission form.
|
| Shipping and Specimen Handling Requirements | - Ship according to Dangerous Goods Regulations, IATA, and/or CFR 49.
- Handle as infectious agent using universal precautions.
- Triple contained in accordance with federal shipping regulations for infectious agents.
Additional forms & resources
|
| Method | EIA for the qualitative detection of antibodies |
| Turn-around Time | 4 working days |
| Interferences/Limitations | A non-reactive result does not exclude the possibility of exposure to hepatitis B virus. |
| Common Causes for Rejection | Insufficient quantity, unacceptable specimen type or source, improper shipping condition, expired media or collection container, discrepancies between specimen label and submission form, and/or incomplete or missing submission form |
| Additional Information | Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection |