Confirm and quantify the presence of hepatitis E virus.
Quantitative Polymerase Chain Reaction
Lavender (EDTA), pink (K2EDTA) or Serum separator tube (SST).
Separate from cells. Transfer 1 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 0.5 mL)
Additional information required: Specimen source
Ambient: 24 hours; Refrigerated: 1 week; Frozen: 1 week
The quantitative range of this assay is 3.3- 8.3 log IU/mL (1,800 - 180,000,000 IU/mL). One IU/mL of HEV RNA is approximately 2.25 copies/mL.
A negative result (less than 3.3 log IU/mL or less than 1,800 IU/mL) does not rule out the presence of PCR inhibitors in the patient specimen or HEV 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 RNA test is 3.3 log IU/mL (1,800 IU/mL). If the test DID NOT DETECT the virus, the test result will be reported as "< 3.3 log IU/mL (< 1,800 IU/mL)." If the test DETECTED the presence of the virus but was not able to accurately quantify the number of international units, the test result will be reported as "Not Quantified."
|Component Test Code*||Component Chart Name||LOINC|
|2011656||Hepatitis E Quant by PCR, Log IU/mL||78750-7|
|2011657||Hepatitis E Quant by PCR, Interp||48767-8|
|2011658||Hepatitis E Quant by PCR, IU/mL||69961-1|
|2011659||Hepatitis E Quant by PCR, Source||31208-2|
- Viral load monitoring