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HelpTEST ID AHDV Hepatitis D Virus (HDV) Total Antibodies with Reflex to HDV RNA Detection and Quantitation, PCR, Serum
Reporting Name
HDV Total Ab + reflex to HDV RNA, SSpecimen Type
SerumNecessary Information
Date of collection is required.
Specimen Required
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 1.5 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.
Specimen Minimum Volume
See Specimen Required
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Frozen (preferred) | 30 days |
| Refrigerated | 5 days |
Special Instructions
Testing Algorithm
This test begins with hepatitis D virus (HDV) total antibodies by enzyme immunoassay. If the result is equivocal or positive, then HDV RNA detection/quantification will be performed at an additional charge.
For more information see Hepatitis D: Diagnostic Testing Algorithm.
Method Name
Enzyme Immunoassay (EIA)
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
Reference Values
Negative
Day(s) Performed
Monday, Friday
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HDVQU | HDV RNA Detect / Quant, S | Yes | No |
Report Available
1 to 7 daysSpecimen Retention Time
14 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
86692
87523 if needed
Forms
If not ordering electronically, complete, print, and send 1 of the following:
-Kidney Transplant Test Request
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 hepatitis B (chronic coinfection), or acute exacerbation of known chronic hepatitis B (HDV superinfection)
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, HDV-specific total antibodies (combined IgM and IgG), or HDV RNA 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 total antibodies and HDV RNA persist in serum after resolution of acute HDV infection and in chronic coinfection.
Cautions
Negative results may not rule out hepatitis D virus (HDV) infection during the early phase of infection or in immunocompromised patients who have delayed or inadequate immune response.
False-positive results may be due to cross-reactive antibodies from other viral infections or underlying illnesses. A positive result should be correlated with the patient's clinical history, physical examination findings, and risk factors for HDV infection. A positive antibody result with negative HDV RNA may be due to either false-positive antibody results or past/resolved hepatitis D.
Performance characteristics have not been established for the following specimen characteristics:
-Grossly icteric (total bilirubin level of >20 mg/dL)
-Grossly lipemic (triolein level of >3000 mg/dL)
-Grossly hemolyzed (hemoglobin level of >500 mg/dL)
-Containing particulate matter
-Cadaveric specimens
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.(Package insert: HDV Ab. International Immuno Diagnostics; Rev. 6 0917)