Hepatitis D Virus (HDV) Qualitative Real-time RT-PCR

Test Code: 3900
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Clinical and Procedure
Clinical Utility

Hepatitis D virus (HDV) is an incomplete RNA virus that requires the helper function of Hepatitis B virus (HBV) envelope proteins (HBSAg) to replicate.  The HDV Real-time RT-PCR assay detects HDV RNA in serum or plasma. 

Procedure

Extraction of nucleic acid from specimen, followed by reverse transcription of viral RNA, then amplification and detection of cDNA using real-time, quantitative PCR. An internal control is added to ensure the extraction was performed correctly and the PCR reaction was not inhibited. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Specificity

The assay is specific for Hepatitis D.

Turnaround Time

7 business days from receipt of specimen.

Specimen Information
Specimen Type Test Code CPT Code NY Approved Volume Assay Range Special Instructions
Plasma (1) 3901 87798 Yes

2 mL (min. 0.5 mL)

Detected/Not Detected
  • Collect 4-5 mL whole blood in EDTA or ACD tube.
  • Avoid using gel separator tubes; samples collected in gel separator tubes have increased rate of PCR inhibition.
  • Centrifuge (optional) and transfer 2 mL plasma to sterile, screw top tube.
  • Alternatively plasma can be shipped in the original collection tube without centrifugation.
  • Can be shipped at ambient or refrigerated temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 7 days of collection.

 

 
Serum (1) 3910 87798 Yes

2 mL (min. 0.5 mL)

Detected/Not Detected
  • Collect 4-5 mL whole blood in red top tube.
  • Avoid using gel separator tubes; samples collected in gel separator tubes have increased rate of PCR inhibition.
  • Centrifuge and transfer 2 mL serum to sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 7 days of collection.
Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Eurofins Viracor test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Eurofins Viracor, 18000 W 99th St. Ste, #10, Lenexa, KS 66219.

Causes for Rejection

Grossly hemolyzed plasma/serum specimens, specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above. The CPT codes provided are based on Eurofins Viracor 'sinterpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Eurofins Viracor assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

References

Price, J. An update on Hepatitis B, D and E Viruses. (2014) Topics in Antiviral Medicine 21(5):157-163.

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