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Test Code LAB7812 Cytomegalovirus (CMV) DNA Detection (Quantitative), plasma

Performing Laboratory

BJH Molecular Infectious Disease Laboratory

Methodology

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

Specimen Requirements

Specimen Type: Plasma.

Container/Tube: Lavender or pink top (EDTA).

Specimen Minimum Volume: Minimum of 2 mL of whole blood in a dedicated lavender or pink top (EDTA) tube.

 

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

 

Collection Instructions:

1.  Spin down and separate plasma from cells within 24 hours of collection.

2.  Plasma should be stored at 2-8°C or -20°C upon separation.  Please see Specimen Stability Information for additional information.

Day(s) Test Set Up

Monday through Sunday.

Turnaround Time (STAT, Routine)    

STAT: Director approval required.

Routine: 24 – 48 hours       

Test Classification and CPT Coding

Test Classification:

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

 

CPT:  87497

 

Reference Values

Not detected.

 

Additional Information

Assay Limit of Detection - Plasma: 34.5 IU/mL

Assay Quantitative Range - Plasma: 34.5 IU/mL - 1.0x107 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:

  • 2 to 25° C  for up to 24 hours

Following separation of plasma from whole blood:

  • Room temperature for up to 72 hours
  • 2 to 8° C for up to 6 days
  • -20° C to -80° C for up to 12 weeks

Specimen Transport Instructions

Whole blood specimens should be delivered to the BJH Molecular Infectious Disease laboratory within 4 hours of collection for processing.