Ordering Recommendation

Use to diagnose hepatitis D virus (HDV) infection in individuals with documented acute or chronic hepatitis B virus (HBV) infection. If result is positive, consider additional HBV IgM core antibody testing to determine whether HDV infection is a coinfection or a superinfection with HBV; refer to Hepatitis B Virus Core Antibody, IgM (0020092).

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation

N/A

Collect

Serum separator tube (SST).

Specimen Preparation

Separate from cells ASAP or within 2 hours of collection. Transfer 2 mL serum to a sterile ARUP standard transport tube. (Min: 1 mL)

Storage/Transport Temperature

Frozen

Unacceptable Conditions

Specimens containing particulate material or obvious microbial contamination. Hemolyzed or lipemic specimens.

Remarks

Specimen source required.

Stability

After separation from cells: Ambient: 24 hours; Refrigerated: 5 days; Frozen: 4 months (avoid repeated freeze/thaw cycles)

Methodology

Qualitative Enzyme Immunoassay (EIA)/Quantitative Polymerase Chain Reaction (PCR)

Performed

Mon, Wed, Fri

Reported

1-5 days
For Reflex: 2-5 days after screen is complete.

Reference Interval

Test Number
Components
Reference Interval
  Hepatitis Delta Antibody by ELISA Negative

Interpretive Data



Compliance Category

Laboratory Developed Test (LDT)

Note

Order this test only when patient has an acute or chronic hepatitis B infection.

If the anti-HDV screening result is positive, Hepatitis Delta Virus by Quantitative PCR (ARUP test code 2013881) will be added. Additional charges apply. Performed and Reported times are for the antibody screening portion of this test. Refer to Hepatitis Delta Virus by Quantitative PCR regarding additional information regarding Performed and Reported times for the reflex portion of the test.

For Screen: The screen test detects total antibodies (IgG and IgM) to the hepatitis Delta agent.

For PCR Reflex: The limit of quantification for this test is 2.1 log IU/mL (120 IU/mL). If the test DID NOT DETECT the virus, the test result will be reported as <2.1 log IU/mL (<120 IU/mL). If the test DETECTED the presence of the virus but was not able to accurately quantify the number of copies, the test result will be reported as Not Quantified.
The quantitative range of the reflexed PCR assay is 2.1-6.8 log IU/mL (120-5,800,000 IU/mL)


A negative PCR result (less than 2.1 log IU/mL or less than 120 IU/mL) does not rule out the presence of PCR inhibitors in the patient specimen or the HDV RNA concentrations below the level of detection of the test. Inhibition may also lead to underestimation of viral quantitation.

Hotline History

N/A

CPT Codes

86692; if reflexed, add 87523

Components

Component Test Code* Component Chart Name LOINC
2013889 Hepatitis Delta Antibody by ELISA 40727-0
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • HDV
  • HDV Ab
  • Hepatitis D Virus
Hepatitis Delta Virus Antibody by ELISA With Reflex to Hepatitis Delta Virus by Quantitative PCR