Confirm and quantify the presence of hepatitis D virus.
Quantitative Polymerase Chain Reaction
New York DOH Approval Status
Serum Separator Tube (SST).
Separate serum from cells. Transport 1 mL serum in a sterile container. (Min: 0.5 mL)
Specimen source required.
Ambient: 24 hours; Refrigerated: 1 week; Frozen: 4 months
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.
Laboratory Developed Test (LDT)
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."
|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|
- Hepatitis D Virus