Test Details
Methodology
Immunochemiluminometric assay (ICMA)
Result Turnaround Time
1 - 3 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 can be used as an aid in the diagnosis of individuals with acute or chronic hepatitis B virus (HBV) infection and in the determination of the clinical status of HBV infected individuals in conjunction with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. This assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. This panel can be used to differentiate between the presence of anti-HBc IgG and IgM.
Special Instructions
Note: Hep B Core AB Total if positive, will reflex to Hep B Core, IgM at an additional charge.
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
The results from this or any other diagnostic kit should be used and interpreted only in the context of the overall clinical picture. A negative test result does not exclude the possiblity of exposure to hepatitis B virus. Levels of anti-HBc may be undetectable both in early infection and late after infection.
This is a qualitative assay; reported antibody level cannot be correlated to an endpoint titer.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients.
Custom Additional Information
Hepatitis B core antigen (HBcAg), found in liver cells, does not circulate in the bloodstream. However, IgM and IgG antibodies to HBcAg can be detected serologically in HBV infected individuals. Anti-HBc IgM is detectable first and remains detectable for approximately six months. Shortly after the IgM response, anti-HBc IgG appears and can remain detectable indefinitely. 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. Anti-HBc Total assays detect both IgM and IgG anti-HBc responses. Most often levels of anti-HBc will coincide with detectable levels of other HBV markers. Rarely, anti-HBc may be the only detectable HBV marker. This may occur during the brief period when hepatitis B surface antigen (HBsAg) has been cleared from the bloodstream and before antibodies to hepatitis B surface antigen (anti-HBs) become detectable. For this reason, the use of anti-HBc Total assays to detect acute infection is not recommended. Anti-HBc Total assays should be used in conjunction with other marker assays to assess current or past exposure to HBV.
Specimen Requirements
Specimen
Serum or plasma
Volume
1 mL
Minimum Volume
0.5 mL (Note: This volume does not allow for repeat testing.)
Container
Gel-barrier transport, red top tube, or lavender-top (EDTA) tube
Collection Instructions
If tube other than gel barrier is used, transfer the 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 |
Storage Instructions
Room temperature
References
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 160101 | Hepatitis B Core Ab W/Reflex | 13952-7 | 006718 | Hep B Core Ab, Tot | 13952-7 | |
| Order Code | 160101 | |||||
| Order Code Name | Hepatitis B Core Ab W/Reflex | |||||
| Order Loinc | 13952-7 | |||||
| Result Code | 006718 | |||||
| Result Code Name | Hep B Core Ab, Tot | |||||
| UofM | ||||||
| Result LOINC | 13952-7 |
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 126881 | HBcIgM | 016881 | Hep B Core Ab, IgM | 24113-3 | |
| Reflex 1 | ||||||
| Order Code | 126881 | |||||
| Order Name | HBcIgM | |||||
| Result Code | 016881 | |||||
| Result Name | Hep B Core Ab, IgM | |||||
| UofM | ||||||
| Result LOINC | 24113-3 | |||||