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Dec 4, 2017

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Clinical Hub,Tools & Resources,UWHC Lab Test Directory,Molecular Diagnostics

Hepatitis C RNA, Quantitative

Hepatitis C RNA, Quantitative (XHCVRQ) Molecular Diagnostics Lab Test

Name: Hepatitis C RNA, Quantitative

Test Name: Hepatitis C RNA, Quantitative

Health Link Test Code: XHCVRQ

LIS Test Code: 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.

 

Result

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.

<10 IU/mL

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.

>100,000,000 IU/mL

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.

Specimen: Blood

Collection Container: Lavender top

Collection Volume: 6 mL

Pediatric Collection Volume: 2 mL

Stability Ambient:

Whole blood - 6 hours

Stability Refridgerated:

Plasma - 5 days

Stability Frozen:

Whole Blood Not acceptable
Plasma

8 weeks at -20 to -80°C
 

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 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.

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:

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

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.