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HelpEPIC ORDER CODE LAB2524 Hepatitis D Virus Total Antibodies, Serum
Additional Codes
SQ: HEDM
Necessary Information
Date of collection is required.
Specimen Required
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL
Collection Instructions:
1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).
2. Aliquot serum into plastic vial.
Useful For
Detection of hepatitis D virus (HDV)-specific total antibodies (combined IgG and IgM) in human serum
Diagnosis of concurrent HDV infection in patients with fulminant acute hepatitis B virus (HBV) infection (acute coinfection), chronic HBV infection (chronic coinfection), or acute exacerbation of known chronic HBV infection (HDV superinfection)
Special Instructions
Method Name
Enzyme Immunoassay (EIA)
Reporting Name
HDV Total Ab, SSpecimen Type
SerumSpecimen Minimum Volume
0.25 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Frozen (preferred) | 30 days | |
| Refrigerated | 30 days |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
Clinical Information
Hepatitis D virus (HDV), also known as delta hepatitis virus, is a defective RNA virus comprised of a delta antigen and a hepatitis B surface antigen as the core and protein coat of the virus, respectively. This virus cannot replicate effectively by itself as it requires the presence of hepatitis B virus (HBV) to initiate and maintain its replication in the infected liver cells.
Infection with HDV occurs either as an acute coinfection with HBV or an acute superinfection of chronic HBV. Acute HBV-HDV coinfection usually follows a self-limited clinical course with spontaneous resolution but may have a fulminant clinical presentation. HDV superinfection in chronic HBV, or HBV carrier state, typically manifests as an acute exacerbation of chronic hepatitis B, with tendency to result in chronic HBV-HDV coinfection and early cirrhosis or liver failure. In the United States, chronic HDV infection is found in 1% of all individuals with a chronic HBV-infection.
Diagnosis of HDV can be established by detecting HDV antigen, HDV-specific IgM, or HDV-specific total antibodies (combined IgM and IgG) in the sera of infected patients with clinically evident acute or chronic hepatitis B. Anti-HDV IgM typically appears in serum at 2 to 3 weeks after onset of symptoms and disappears by 2 months after acute HDV infection, but it may persist up to 9 months in HDV superinfection. HDV IgG and HDV total antibodies persist in serum after resolution of acute HDV infection and in chronic coinfection.
Reference Values
Negative
Interpretation
This assay detects the presence of hepatitis D virus (HDV)-specific total (combined IgG and IgM) antibodies in serum.
Negative results indicate the absence of HDV infection and no past exposure to HDV.
Equivocal results indicate borderline level of anti-HDV total antibodies. Repeat testing in 1 to 2 weeks is recommended to determine the definitive HDV infection status.
Positive results usually indicate simultaneous acute or chronic coinfection with hepatitis B virus (HBV) and HDV; acute HDV infection in patients with known chronic HBV infection (ie, HDV superinfection); or resolved HDV infection. Results should be correlated with medical history and clinical findings.
For more information, see Viral Hepatitis Serologic Profiles.
Clinical Reference
1. Olivero A, Smedile A: Hepatitis delta virus diagnosis. Semin Liver Dis. 2012 Aug;32(3):220-227
2. Shah PA, Choudhry S, Reyes KJC, Lau DTY: An update on the management of chronic hepatitis D. Gastroenterol Rpt (Oxf). 2019 Oct;7(6):396-402. doi: 10.1093/gastro/goz052
3. Chen LY, Pang XY, Goyal H, et al: Hepatitis D: challenges in the estimation of true prevalence and laboratory diagnosis. Gut Pathog. 2021 Oct;13(1):66. doi. 10.1186/s13099-021-00462-0
Method Description
This test is performed using a competitive enzyme immunoassay in which hepatitis delta virus-specific antibodies (anti-HDV) compete with virus-specific polyclonal IgG antibody that is labeled with horseradish peroxidase (HRP) for a fixed amount of recombinant HDV protein coated on the microplate wells. Patient serum sample is added first to the microplate well, in which anti-HDV IgG and IgM antibodies will bind to the recombinant HDV protein coated in the well. After washing, a polyclonal anti-HDV-enzyme conjugate is added and allowed to bind to unbound recombinant HDV protein coated in the well. After another wash, a chromogenic mixture is added as a substrate for the HRP enzymatic reaction. Concentration of the enzyme conjugate bound to the coated well is inversely proportional to the amount of anti-HDV total antibodies present in the patient sample. The concentration of anti-HDV total antibodies present is determined by comparing the calorimetric reaction signal to a calibrated cut-off signal value.
Day(s) Performed
Monday, Friday
Report Available
1 to 7 daysSpecimen Retention Time
14 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
86692
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| AHDV | HDV Total Ab, S | 40727-0 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 9209 | HDV Total Ab, S | 40727-0 |
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