Home
HelpTest Code HDVQU Hepatitis D Virus RNA Detection and Quantification, Real-Time RT-PCR, Serum
Ordering Guidance
This test should be requested for all individuals who are newly confirmed to be positive for hepatitis B virus surface antigen (HBsAg) or HDV total antibodies in serum.
Shipping Instructions
1. Freeze serum immediately, and ship specimen frozen on dry ice.
2. If shipment will be delayed for more 24 hours, freeze serum at -20 to -80° C (up to 35 days) until shipment on dry ice.
Specimen Required
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 2.2 mL
Collection Instructions:
1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge within 2 hours of collection for BD Vacutainer tubes).
2. Aliquot serum into plastic vial.
Useful For
Detection of hepatitis D virus (HDV) for diagnosis of acute or chronic hepatitis D
Determine HDV RNA level in serum to monitor progression and response to antiviral therapy for chronic hepatitis D
Testing Algorithm
For more information see Hepatitis D: Diagnostic Testing Algorithm.
Method Name
Real-Time, Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
Reporting Name
HDV RNA Detect / Quant, SSpecimen Type
Serum SSTSpecimen Minimum Volume
1.0 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum SST | Frozen (preferred) | 35 days | ALIQUOT TUBE |
| Refrigerated | 5 days | ALIQUOT TUBE |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | OK |
Clinical Information
Infection with the hepatitis delta virus (HDV) always occurs in association with hepatitis B virus (HBV) infection, where it may occur either as acute co-infection or acute super-infection superimposed upon existing chronic hepatitis B. HDV is an RNA virus that requires the presence of HBV for viral replication.
Diagnosis of acute HBV-HDV co-infection and HDV super-infection depends upon the presence of HDV antigen (HDV Ag) and HDV RNA in serum or plasma, with or without the presence of HDV-specific total antibodies, in addition to detectable hepatitis B virus surface antigen (HBs Ag), HBV e antigen, and/or HBV core total antibodies. Individuals with acute HBV-HDV co-infection will have detectable HBV core IgM antibody, which is absent in those with HDV super-infection with pre-existing chronic hepatitis B.
In acute co-infection, HDV Ag and HDV RNA appears early after HBs Ag becomes detectable and then both disappear with convalescence, while both markers persist in HDV superinfection that frequently leads to chronic HBV-HDV co-infection. HDV total antibodies persist in both resolved and chronic co-infection.
Reference Values
Undetected
Interpretation
Quantification range of this assay is 20 to 2,000,000 IU/mL (1.30 log to 6.30 log IU/mL), with a limit of detection (based on a 95% detection rate) of 4.17 IU/mL (0.62 log IU/mL).
An "Undetected" result indicates that hepatitis D virus (HDV) RNA is not detected in the serum specimen (see Cautions). Repeat testing in 1 to 2 months is recommended for those at risk of HDV infection. The limit of detection (based on a 95% detection rate) for this assay is 4.17 IU/mL.
A result of "<20 IU/mL" indicates that the HDV RNA level present in the serum specimen is below 20 IU/mL (1.30 log IU/mL), and the assay cannot accurately quantify the HDV RNA present below this level.
A quantitative value (reported in IU/mL and log IU/mL) indicates the HDV RNA level (ie, viral load) present in the serum specimen.
A result of ">2,000,000 IU/mL" indicates that the HDV RNA level present in the serum specimen is above 2,000,000 IU/mL (6.30 log IU/mL), and this assay cannot accurately quantify the HDV RNA present above this level.
An "Inconclusive" result indicates that the presence or absence of HDV RNA in the serum specimen could not be determined with certainty after repeat testing in the laboratory, possibly due to reverse transcription-polymerase chain reaction inhibition. Submission of a new specimen for testing is recommended.
Cautions
This assay is optimized for the detection and quantification of hepatitis D virus (HDV) genotypes 1 to 8, but due to unexpected mismatches between the polymerase chain reaction assay primers and unusual or rare HDV target sequences, some serum specimens may yield "Undetected" results despite the presence of HDV RNA. Therefore, results should be interpreted with caution, considering the patient's risk factors for HDV infection, the analytical sensitivity of the assay, and possible geographic origin of the infecting HDV strain. Follow-up HDV RNA testing is recommended for patients with initially "Undetected" HDV RNA test results but at high risk for or suspected to have chronic hepatitis D.
In immunocompetent individuals, undetectable HDV RNA results indicate only the absence of HDV RNA in the serum specimen tested but do not exclude the diagnosis of HDV infection, given the relatively short duration of viremia (2 to 8 weeks after infection) in these individuals. Immunocompetent individuals with HDV infection would be expected to have repeatedly positive HDV-specific IgG and total antibody test results.
Heparinized or visibly lipemic serum specimens may result in reduced assay sensitivity, with possible false-negative or under-quantified HDV RNA test results.
Due to differences in design and analytical performance for different assays detecting and quantifying HDV RNA in human serum, serial testing of HDV viral load in a given patient over time should be performed using the same molecular assay.
Day(s) Performed
Varies (once per week)
Report Available
1 to 10 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
87523
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| HDVQU | HDV RNA Detect / Quant, S | 85512-2 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 621375 | HDV RNA Detect / Quant, S | 85512-2 |