Name: Hepatitis C RNA, Quantitative
Test Name: Hepatitis C RNA, Quantitative
Health Link Test Code: XHCVRQ
LIS Test Code: HCVRNA
CPT Code(s): 87522
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.
Clinical information based on result
Target Not Detected
No current HCV infection.
Follow-up testing is recommended as per national HCV guielines for viral load assessment, and no further testing is recommended for diagnosis of HCV.
Follow-up testing is recommended as per national HCV guidelines for viral load assessment and results must be interpreted within context of all relevant clinical and laboratory findings for diagnosis of HCV.
10 - 25 IU/mL
Provide guidance for treatment and care based on current national HCV treatment guidelines for diagnosis of HCV and viral load assessment.
25 - 100,000,000 IU/mL
Current HCV infection.
Provide guidance for treatment and care based on current national HCV treatment guidelines for diagnosis and viral load assessment.
Current HCV infection.
For HCV Diagnosis and Viral Load assessment, Provide guidance for treatment and care based on current national HCV treatment guidelines.
Days Performed: Twice a week-days vary.
In-Lab Turnaround Time: 5 days.
Stat In-Lab Turnaround Time: Not available stat.
Collection Container: Lavender top
Collection Volume: 6 mL
Pediatric Collection Volume: 2 mL
Whole blood - 6 hours
Plasma - 5 days
|Whole Blood||Not acceptable|
||8 weeks at -20 to -80°C|
Sample Analyzed: Plasma
Testing Volume: 3 mL
Pediatric Testing Volume: 1.2 mL
Separate cell-free plasma from whole blood and transfer to a sterile polypropylene tube within 6 hours of collection. Freeze plasma at -60°C to -80°C (preferred). Prior to freezing at -60°C to -80°C, EDTA plasma may also be stored at either 2°C to 8°C for up to 5 days or frozen at -20 - -80°C for up to 8 weeks.
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.
Transport specimen to Laboratory immediately.
Whole blood specimens greater than 6 hours old when received by laboratory are not acceptable.
If HCV is detected, two results are reported for each assay: a measured log10 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 log10 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.
Interpretation Type: Interpretive Guidelines
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.
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.