Ordering Recommendation

Confirm and quantify the presence of hepatitis D virus.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Serum Separator Tube (SST).

Specimen Preparation

Separate serum from cells. Transport 1 mL serum in a sterile container. (Min: 0.5 mL)

Storage/Transport Temperature

Frozen.

Unacceptable Conditions
Remarks

Specimen source required.

Stability

Ambient: 24 hours; Refrigerated: 1 week; Frozen: 4 months

Methodology

Quantitative Polymerase Chain Reaction

Performed

Mon, Thu

Reported

2-5 days

Reference Interval

Not Detected

Interpretive Data

The quantitative range of this assay is 2.1-6.8 log IU/mL (120 - 5,800,000 IU/mL).

A negative result (less than 2.1 log IU/mL or less than 120 IU/mL) does not rule out the presence of PCR inhibitors in the patient specimen or HDV RNA concentrations below the level of detection of the test. Inhibition may also lead to underestimation of viral quantitation.

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Compliance Category

Laboratory Developed Test (LDT)

Note

The limit of quantification for this test is 2.1 log IU/mL (120 IU/mL). If the test DID NOT DETECT the virus, the result will be reported as "< 2.1 log IU/mL (< 120 IU/mL)." If the test DETECTED the presence of the virus but was not able to accurately quantify the number of copies, the result will be reported as "Not Quantified."

Hotline History

N/A

CPT Codes

87523

Components

Component Test Code* Component Chart Name LOINC
2013883 HDV by Quantitative PCR, Source 31208-2
2013884 HDV by Quantitative PCR, IU/mL 85512-2
2013885 HDV by Quantitative PCR, Log IU/mL 85513-0
2013886 HDV by Quantitative PCR, Interp 7906-1
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • HDV
  • Hepatitis D Virus
Hepatitis Delta Virus by Quantitative PCR