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UW Health SMPH
American Family Children's Hospital

UW Hospital and Clinics Lab Test Directory

Test Name: Hepatitis C RNA, Quant, PCR

Test Code(s): HCVRNA / XHCVRQ

CPT Code(s): 87522

Methodology: Reverse-Transcription plus Real-Time PCR

Clinical Significance: While not FDA approved to directly diagnosis infection, but rather to assess viral burden in infected patients, detection of HCV RNA by real time reverse transcription-PCR (RT-PCR) tests, such as the Roche Cobas Ampliprep and Roche COBAS Taqman HCV v2.0, can be used to confirm reactive serologic screening test results.

Days Performed: Twice a week-days vary.

Turnaround Time: Stat: Not available stat.
Routine: 5 days.


Specimen Requirements

Specimen: Blood

Collection Container: Preferred: Lavender top

Collection Volume: Preferred: 6 mL
Pediatrics: 2 mL

Sample Analyzed: Plasma

Volume Required: Preferred: 3 mL
Pediatrics: 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 to -80C (preferred). Prior to freezing at -60 to -80C, EDTA plasma may also be stored at either 2 to 8C for up to 72 hours or frozen at -20C for up to 7 days.

Specimen Transport: Transport specimen to UWHC Core Laboratory (B4/220) immediately.

Outreach Specimen Transport: Transport frozen specimen on dry ice to UWHC Core Laboratory (B4/220).

Unacceptable Criteria: Whole blood specimens greater than 6 hours old when received by laboratory are not acceptable.

Stability: Ambient: Whole blood - 6 hours
Refrigerated: Plasma - 3 days
Frozen: Whole blood- Not acceptable frozen; Plasma - 6 weeks at -70C or 7 days at -20C.


Interpretation

Interpretive Guidelines:

If HCV is detected, two results are reported for each assay: a measured log10 International units/mL and a calculated International units/mL result.

 

Analytical measurement range of this assay is 15-100,000,000 International Units/mL (1.18-8.00 log10 International Units/mL). In patients where HCV is detected but outside of the analytical measurement range (AMR), a result of <15 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 is a reverse-transcription real-time PCR assay. While not FDA approved to directly diagnosis infection, but rather to assess viral burden in infected patients, detection of HCV RNA by real time reverse transcription-PCR (RT-PCR) tests, such as the Roche Cobas Ampliprep and Roche COBAS Taqman HCV v2.0, can be used to confirm reactive serologic screening test results. This test does not genotype 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 Cobas Ampliprep and Cobas Taqman methodology by Roche Diagnostics. This test is performed pursuant to an agreement with Roche Molecular Systems, Inc.

 

This test is approved by the U.S. Food and Drug Administration.

HCV, hepatitis C virus, HCVQHI, HCVQLO, HCVPCR

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