Hepatitis D Virus (HDV) Antibody, IgG/IgM

CPT: 86692

Synonyms

  • HBV
  • Hepatitis delta

Special Instructions

This test is not approved in New York state.


Expected Turnaround Time

Daily


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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