Ordering Recommendation

Confirm and quantify the presence of hepatitis D virus.

Mnemonic
HDV QNT
Methodology

Quantitative Polymerase Chain Reaction

Performed

Mon, Thu

Reported

2-5 days

New York DOH Approval Status
This test is New York DOH 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

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.

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

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
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