Detect and quantify herpesvirus 8 (HHV-8).
Quantitative Polymerase Chain Reaction
Lavender (EDTA), Pink (K2 EDTA), or Serum Separator Tube (SST).
Separate serum or plasma from cells. Transport 1 mL plasma, serum, or whole blood in a sterile container. (Min: 0.5 mL)
Specimen source required.
Ambient: 24 hours; Refrigerated: 1 week; Frozen: 1 year
The quantitative range of this assay is 3.8-8.8 log copies/mL (6,670 - 667,000,000 copies/mL).
A negative result (less than 3.8 log copies/mL or less than 6,670 copies/mL) does not rule out the presence of PCR inhibitors in the patient specimen or HHV8 DNA concentrations below the level of detection of the test. Inhibition may also lead to underestimation of viral quantitation.
No international standard is currently available for calibration of this assay. Caution should be taken when interpreting results generated by different assay methodologies.
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 DNA test is 3.8 log copies/mL (6,670 copies/mL). If the test DID NOT DETECT the virus, the test result will be reported as "< 3.8 log copies/mL (< 6,670 copies/mL)." If the test DETECTED the presence of the virus but was not able to accurately quantify the number of copies, the test result will be reported as "Not Quantified."
|Component Test Code*||Component Chart Name||LOINC|
|2013090||HHV8 by Quantitative PCR, Source||31208-2|
|2013091||HHV8 by Quantitative PCR, Copy/mL||49404-7|
|2013092||HHV8 by Quantitative PCR, Log copy/mL|
|2013093||HHV8 by Quantitative PCR, Interp||39083-1|
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