Hepatitis B Virus Core IgM Antibody, Serum
Use
Diagnosis of acute hepatitis B virus (HBV) infection. Identifying acute HBV infection in the serologic window period when HBV surface antigen and HBV surface antibody results are negative. Differentiation between acute, chronic, or past HBV infections in the presence of positive hepatitis B virus core total antibodies.
Special Instructions
Not provided.
Limitations
This assay has not been licensed by the US Food and Drug Administration for the screening of blood, plasma, and tissue donors. Results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings. Serum specimens from individuals taking biotin supplements of more than 20 mg per day may have false-negative results due to interference. False-positive results may occur due to the presence of interfering substances. Methods may not detect all infected individuals. Interference from high titers of antibodies, streptavidin, or ruthenium can occur. Assay performance not established for certain populations or specimen types.
FDA ApprovedNew York Approved
Methodology
Immunoassay (ECLIA)
Biomarkers
HBc IgM Ab
Antibody
LOINC Codes
- 24113-3 - HBV core IgM SerPl Ql IA
- 24113-3 - HBV core IgM SerPl Ql IA
Result Turnaround Time
1-2 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
0.6 mL
Minimum Volume
0.6 mL
Container
Serum gel; Plastic vial
Collection Instructions
Centrifuge blood collection tube per manufacturer's instructions. Aliquot serum into a plastic tube.
Patient Preparation
For 24 hours before specimen collection, patient should not take multivitamins or dietary supplements containing biotin (vitamin B7).
Causes for Rejection
Gross hemolysis, gross lipemia, gross icterus
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 72 hours |
| Refrigerated | 6 days |
| Frozen | 90 days |