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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.
Secondary ID
621375Useful 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)
Specimen 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 |
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.
Method Description
This assay utilizes the real-time polymerase chain reaction (PCR) with TaqMan probe chemistry with the RealStar HDV RT-PCR Kit 1.0 (altona Diagnostics GmbH, Hamburg, Germany) for qualitative and quantitative detection of hepatitis D virus (HDV) RNA in human serum. Testing involves 3 major processes with the ELITe InGenius integrated system: automated extraction and purification of viral and internal control (MS2 phage) RNA, reverse transcription of HDV RNA target sequence and MS2 RNA to generate complementary DNA (cDNA), PCR amplification, and real-time detection of amplified products with fluorescent dye-labeled oligonucleotide probes. This assay amplifies a conserved sequence located between two autocatalytic sites in the HDV genome, with simultaneous detection and quantification of the target-specific amplified products and the MS2 (internal control) sequence. The assay is calibrated to the First World Health Organization International Standard for HDV RNA, PEI code 7657/12, and test results are reported in IU/mL.(Package insert: RealStar HDV RT-PCR Kit 1.0. Altona Diagnostics GmbH; 05/2018)
Day(s) Performed
Varies (once per week)
Report Available
1 to 10 daysSpecimen Retention Time
2 monthsPerforming Laboratory
Mayo Clinic Laboratories in Rochester
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 |