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| UWHC Lab Test Details | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Test Name | Hepatitis C RNA, Quantitative (Viral Load) | ||||||||||||
| Test Code(s) | XHCVRQ, HCVRNA | ||||||||||||
| CPT Code(s) | 87522 | ||||||||||||
| Methodology | Aptima | ||||||||||||
| Clinical Information | The test is intended for use as a monitor for viral load assessment and as an aid in diagnosis of HCV infection in following populations: individuals with antibody evidence of HCV infection with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection.
| ||||||||||||
| Days Performed | Twice a week-days vary. | ||||||||||||
| In-Lab Turnaround Time | 5 days. | ||||||||||||
| Stat In-Lab Turnaround Time | Not available stat. | ||||||||||||
| Collection Requirements | |||||
|---|---|---|---|---|---|
| Specimen | Blood | ||||
| Collection Container |
| ||||
| Collection Volume | 6 mL | ||||
| Pediatric Collection Volume | 2 mL | ||||
| Specimen Processing Requirements | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stability |
| |||||||||||
| Sample Analyzed | Plasma | |||||||||||
| Testing Volume | 3 mL | |||||||||||
| Pediatric Testing Volume | 1.2 mL | |||||||||||
| Specimen Processing | Separate cell-free plasma from whole blood and transfer to a sterile polypropylene tube or inpeco tube within 6 hours of collection. EDTA plasma may be stored at 2°C to 8°C for up to 5 days or frozen at -20°C for up to 60 days.
This test cannot be added on to specimens previously collected due to stability and cross-contamination issues. Please place a new order for a new specimen collection. | |||||||||||
| Outreach Specimen Processing | Transport frozen specimen on dry ice to Laboratory. | |||||||||||
| Specimen Transport | Transport specimen to Laboratory immediately. | |||||||||||
| Unacceptable Criteria | Whole blood specimens greater than 6 hours old when received by laboratory are not acceptable. | |||||||||||
| Interpretation | |
|---|---|
| Interpretive Guidelines | If HCV is detected, two results are reported for each assay: a measured log International units/mL and a quantitative International units/mL result.
Analytical Measurement Range (AMR) used for both Diagnostic and Viral Load Assessment, of this assay is 10 - 100,000,000 International units/mL (1.00-8.00 log International Units (IU)/mL). In patients where HCV is detected but outside of the analytical measurement range (AMR), a result of <10 IU/mL or > 100,000,000 IU/mL will be reported.
If no HCV is detected, a result of "Not detected" will be reported.
|
| Test Limitations | This test does not genotype the virus.
Though rare, mutations within the highly conserved regions of the viral genome covered by the primers and/or probes in the Aptima HCV Quant Dx assay may result in failure to detect the virus. |
| Additional Information | The remaining sample (plasma) will be stored in the laboratory for 3 weeks for future testing. Hepatitis C genotyping can be performed if there is sufficient sample volume and if the viral load of the stored specimen is >22,000 international units/mL. Please note on add-on request to use the stored sample.
Specimens are assayed using the Hologic Aptima HCV Quant Dx Assay.
This test is approved by the U.S. Food and Drug Administration. |
