Test Details
Methodology
Immunochemiluminometric assay (ICMA)
Result Turnaround Time
1 - 2 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Use
This assay may be used in combination with other hepatitis B virus (HBV) marker assays to define the clinical status of known HBV infected patients or can be combined with other HBV, HAV (hepatitis A virus), and HCV (hepatitis C virus) assays for the diagnosis of patients presenting with symptoms of acute viral hepatitis.
Special Instructions
This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.
Limitations
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, or patients less than 2 years of age.
Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays. Patients routinely exposed to animals or to animal serum products can be prone to this interfence and anomalous values may be observed. Additional information may be required for diagnosis.
A reactive anti-HBc IgM result does not exclude co-infection by another hepatitis virus.
Assay performance characteristics have not been established when the ADVIA Centaur HBc IgM assay is used in conjunction with other manufacturers' assays for specific HBV serological markers.
Custom Additional Information
Anti-HBc IgM increases rapidly, peaks during the acute infection stage of HBV infection, and then falls to a relatively low level as the patient recovers or becomes a chronic carrier. Anti-HBc IgM is useful in the diagnosis of acute HBV infection even when HBsAg concentrations are below the sensitivity of the diagnostic assay. The presence of anti-HBc IgM and anti-HBc IgG is characteristic of acute infection, while the presence of anti-HBc IgG without anti-HBc IgM is characteristic of chronic or recovered stages of HBV infection. The use of other viral markers such as HBsAg, anti-HBs, and anti-HBc total to differentiate acute from chronic hepatitis B is inconclusive because most of these markers are alsoseen in chronic infection.
Specimen Requirements
Specimen
Serum or plasma
Volume
1 mL
Minimum Volume
0.4 mL (Note: This volume does not allow for repeat testing.)
Container
Red-top tube, gel-barrier tube, or lavender-top (EDTA) tube
Collection Instructions
If tube other than a gel-barrier tube is used, transfer separated serum or plasma to a plastic transport tube.
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 14 days |
Refrigerated | 14 days |
Frozen | 14 days |
Freeze/thaw cycles | Stable x3 |
Reference Range
Negative
Storage Instructions
Room temperature
Causes for Rejection
Non-EDTA plasma specimen; PST gel-barrier tubes
References
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 016881 | Hep B Core Ab, IgM | 24113-3 | 016881 | Hep B Core Ab, IgM | 24113-3 | |
| Order Code | 016881 | |||||
| Order Code Name | Hep B Core Ab, IgM | |||||
| Order Loinc | 24113-3 | |||||
| Result Code | 016881 | |||||
| Result Code Name | Hep B Core Ab, IgM | |||||
| UofM | ||||||
| Result LOINC | 24113-3 |