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Mayo Test ID AHDV Hepatitis D Virus (HDV) Total Antibodies with Reflex to HDV RNA Detection and Quantitation, PCR, Serum


Necessary 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.


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)

Method Name

Enzyme Immunoassay (EIA)

Reporting Name

HDV Total Ab + reflex to HDV RNA, S

Specimen Type

Serum

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time
Serum Frozen (preferred) 30 days
  Refrigerated  5 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, 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.

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. All such antibody-positive specimens will automatically reflex to HDV RNA testing. Results should be correlated with medical history and clinical findings.

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

Clinical Reference

1. Shah PA, Choudhry S, Reyes KJC, Lau DTY: An update on the management of chronic hepatitis D. Gastroenterol Rpt (Oxf). 2019;7(6):396-402. doi: 10.1093/gastro/goz052

2. Chen LY, Pang XY, Goyal H, et al: Hepatitis D: challenges in the estimation of true prevalence and laboratory diagnosis. Gut Pathog. 2021;13(1):66. doi. 10.1186/s13099-021-00462-0

3. Razavi HA, Buti M, Terrault NA, et al: Hepatitis D double reflex testing of all hepatitis B carriers in low-HBV- and high-HBV/HDV-prevalence countries. J Hepatol 2023;79:576-580. https://doi.org/10.1016/j.jhep.2023.02.041

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)

Day(s) Performed

Monday, Friday

Report Available

1 to 7 days

Specimen Retention Time

14 days

Performing 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

87523 if needed

LOINC Code Information

Test ID Test Order Name Order LOINC Value
AHDV HDV Total Ab + reflex to HDV RNA, S 40727-0

 

Result ID Test Result Name Result LOINC Value
9209 HDV Total Ab, S 40727-0

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
HDVQU HDV RNA Detect / Quant, S Yes No

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.