Confirm and quantify the presence of hepatitis D virus.
Quantitative Polymerase Chain Reaction
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.
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.
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