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Order 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

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)

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