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Synonyms
- HBV
- Hepatitis delta
Special Instructions
This assay currently is not available in New York state.
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This assay currently is not available in New York state. |
Expected Turnaround Time
Daily
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.
Related Documents
Specimen Requirements
Specimen
Serum or EDTA-plasma
Volume
0.5 mL
Minimum Volume
0.2 mL (Note: This volume does not allow for repeat testing.)
Container
Gel-barrier tube or lavender-top (EDTA) tube
Collection
Standard blood collection technique
Storage Instructions
Room temperature
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 14 days |
| Refrigerated | 14 days |
| Frozen | 14 days |
| Freeze/thaw cycles | Stable x3 |
Causes for Rejection
Gross hemolysis, lipemia or visible microbial contamination; heat-inactivated samples; specimens other than serum and EDTA plasma
Test Details
Use
This assay is used for the qualitative detection of Hepatitis D virus (HDV) antibodies (IgG/IgM) and is intended to aid in the diagnosis of HDV infection in individuals with known HBV infection (HBsAg-positive). Testing for HDV RNA should be performed on HDV antibody-positive individuals to differentiate between active and resolved HDV infection.
Limitations
A reactive specimen should be investigated further with sensitive, supplemental HDV-specific tests, such as identification of HDV RNA, to be matched with the clinical story of the subject and with markers of a previous HBV infection (HBsAg, anti-HB Core, HBV DNA, etc.). Like all immunoassays, this assay may occasionally yield nonspecific reactions due to other causes. A nonreactive test result for HDV antibodies does not exclude the possibility of exposure to or infection with HDV. Further investigations with alternative HDV-specific tests are suggested in case of suspected infection despite the negative finding.
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
Methodology
Chemiluminescent immunoassay (CLIA)
References
European Association for the Study of the Liver. EASL Clinical Practice Guidelines on hepatitis delta virus. J Hepatol. 2023 Aug;79(2):433-460. Epub 2023 Jun 24.37364791
Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr; 67(4):1560-1599.2940532
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