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Test 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, S

Specimen Type

Serum SST

Specimen 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.

Day(s) Performed

Varies (once per week)

Report Available

1 to 10 days

Performing 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