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Test Code LAB887 Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR (RT-PCR)

Performing Laboratory

BJH Molecular Infectious Disease Laboratory

Methodology

Testing is performed by real-time PCR on the cobas® 6800 platform using the cobas®HCV Assay (Roche Molecular Systems, Inc.).   

Specimen Requirements

Specimen Type:  Serum or Plasma

Collection Container/Tube:  Serum SST or EDTA

Specimen Minimum Volume: Minimum of 2 mL of whole blood in a dedicated Serum SST or EDTA tube
 

**Facilities outside of BJH should submit a minimum of 1 mL of serum or plasma.

 

Collection Instructions:

  1. Spin down and separate serum or plasma from cells within 24 hours of collection.
  2. Serum or plasma should be stored at 2-8°C or -20°C upon separation.  Please see Specimen Stabiity Information for additional details.

Day(s) Test Set Up

Monday through Friday

Turnaround Time:
STAT: Director approval required

Routine: 3 to 5 business days

Test Classification and CPT Coding

This assay is FDA cleared for quantitative HCV RNA testing on plasma and its performance has been evaluated by the Barnes-Jewish Hospital Molecular Infectious Disease Laboratory.

 

87522

 

Reference Values

Not Detected.

Additional Information

Assay Limit of Detection

15 IU/mL

Assay Quantitative Range

15 IU/mL - 100,000,000 IU/mL.

 

For BJH Laboratory Use Only

Laboratory Processing Instructions:

 

Specimens should be delivered to the BJH MID laboratory.  Specimen is stored frozen at the BJH MID lab for 21 days.

Specimen Stability Information

Serum or plasma specimens may be stored under the following conditions:

Prior to separation:

  • Room temperature for up to 24 hours.

Following separation of plasma or serum from whole blood:

  • 2 to 25° C  for up to 24 hours.
  • 4° C for up to 72 hours.
  • -20° C to -80° C for up to 6 months.

 

 

Specimen Transport Instructions

Whole blood specimens should be delivered to the BJH MID laboratory within 24 hours of collection for processing.