Test Catalog

Test Id : AHDV

Hepatitis D Virus Total Antibodies, Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

Enzyme Immunoassay (EIA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

HDV Total Ab, S

Aliases
Lists additional common names for a test, as an aid in searching

Anti-HDV

Anti-HDV total

Delta hepatitis

HDV

HDV total antibodies

Hepatitis D

Hepatitis D virus

Hepatitis D virus antibodies

Hepatitis D total antibodies

Hepatitis delta total antibodies

AHDV

Specimen Type
Describes the specimen type validated for testing

Serum

Necessary Information

Date of collection is required.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

If not ordering electronically, complete, print, and send 1 of the following:

-Gastroenterology and Hepatology Client Test Request (T728)

-Infectious Disease Serology Test Request (T916)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.2 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Frozen (preferred) 30 days
Refrigerated 30 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

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)

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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 (HBsAg) 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 in 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. Chronic HDV infection is found in 1% of all chronically HBV-infected individuals in the United States.

 

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
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

Interpretation
Provides information to assist in interpretation of the test results

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 one of the following conditions: 1) simultaneous acute or chronic coinfection with hepatitis B virus (HBV) and HDV, 2) acute HDV infection in patients with known chronic HBV infection (ie, HDV superinfection), or 3) resolved HDV infection. Results should be correlated with medical history and clinical findings.

 

See Viral Hepatitis Serologic Profiles in Special Instructions.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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 infection or underlying illnesses. Positive result should be correlated with the patient's clinical history, physical examination findings, and risk factors for HDV infection.

 

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

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Hughes SA, Wedemeyer H, Harrison PM: Hepatitis delta virus. Lancet. 2011;378:73-85

2. Pascarella S, Negro F: Hepatitis D virus: an update. Liver International. 2011;31(1):7-21

3. Olivero A, Smedile A: Hepatitis delta virus diagnosis. Semin Liver Dis. 2012;32:220-227

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Description
Describes how the test is performed and provides a method-specific reference

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 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 09/2017)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday, Thursday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 7 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86692

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
AHDV HDV Total Ab, S 40727-0
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
9209 HDV Total Ab, S 40727-0

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports