Hepatitis D Virus (HDV) IgM

Test Code: 30336
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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 presence of HDV IgM antibodies indicates recent exposure to HDV.

Procedure

The Hepatitis D IgM Assay is an enzyme linked capture immunoassay. IgM contained in the sample is captured by monoclonal antibody against human IgM immobilized on the solid phase. Hepatitis D specific IgM is detected with an HRP conjugated HDV antigen complex. Positive samples will have OD values above the established cutoff. This test was developed and its performance characteristics determined by Viracor-IBT Laboratories. It has not been cleared or approved by the U.S. Food and Drug Administration. Results should be used in conjunction with clinical findings, and should not form the sole basis for a diagnosis or treatment decision.

Specificity

The assay is specific for Hepatitis D.

Turnaround Time

1-5 business days from receipt of specimen.

Specimen Information
Specimen Type Order Code CPT Code NY Approved Volume Assay Range Special Instructions
plasma 30336 86692 Yes

2 mL (min. 0.5 mL)

Negative/Equivocal/Positive
  • Collect 4-5 mL whole blood in EDTA or ACD tube, centrifuge and transfer 2 mL plasma 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.
Serum (1) 30336 86692 Yes

2 mL (min. 0.5 mL)

Negative/Equivocal/Positive
  • Collect 4-5 mL whole blood in red top tube, 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 Viracor Eurofins test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor Eurofins, 18000 W 99th St., Lenexa, KS 66219.

Causes for Rejection

Sample types other than serum and plasma. Samples beyond their stability.

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 Viracor Eurofins' interpretation 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. Viracor Eurofins 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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