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Test Code LAB951 Hepatitis B Virus (HBV) DNA Detection and Quantification by Real-Time PCR

Performing Laboratory

BJH Molecular Infectious Disease Laboratory

Methodology

Testing is performed by real-time PCR on the cobas® 6800 platform using the cobas® HBV 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 Stability Information for additional details.

Day(s) Test Set Up

Tuesday and Thursday

Turnaround Time:
STAT: Director approval required.

Routine: 3 to 5 business days.

Test Classification and CPT Coding

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

 

87517

Reference Values

Not Detected.

Additional Information

Assay Limit of Detection

10 IU/mL

Assay Quantitative Range

10 IU/mL - 1,000,000,000 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

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:

  • Room temperature for up to 72 hours.
  • 2-8° C for up to 7 days.
  • -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.