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Test Code LAB4901 BK Virus DNA Detection and Quantification

Performing Laboratory

Barnes-Jewish Hospital Molecular Infectious Disease Laboratory

Methodology

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

Specimen Requirements

Acceptable Specimens:

Plasma or Urine

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.

 

Plasma Collection Procedure:

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

Specimen Type: Urine

Container/Tube: Sterile, preservative-free container or cobas® PCR Urine Sample Kit if specimen cannot be transferred to the laboratory within 24 hours.

Specimen Minimum Volume: Collect a random urine (5-10mL) into a sterile, plastic, preservative-free container.

 

Urine Collection Instructions for cobas® PCR Urine Sample Kit:

  1. Transfer 4.3 mL of urine into the cobas®  PCR Urine Sample tube using the disposable pipette provided within 24 hours of collection. The correct volume of urine has been added when the fluid level is between the black fill lines on the urine transport tube. Place the labels on the transport tube so the black fill lines are still visible for volume confirmation by the laboratory.
  2. Transport and store urine specimen transport container at 2 to 25°C. Please see Specimen Stability Information for Additional details.

Call Barnes Jewish Hospital Laboratory Customer Service at 314-362-1470 to obtain the cobas®  PCR Urine Sample Kit

 

Day(s) Test Set Up

Monday, Wednesday, Friday

Turnaround Time:
STAT: not available
Routine: 1-3 days, Final report available the day of testing

Test Classification and CPT Coding

Test Classification:

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

CPT: 87799

Specimen Stability Information

Specimens may be stored under the following conditions:

Plasma

Prior to separation:

  • 2 to 25° C  for up to 24 hours

Following separation of plasma from whole blood:

  • 2 to 8° C for up to 6 days
  • -15° C to -80° C for up to 6 months

Urine

  • 2 to 25° C (24 hours prior to transfer, 90 days after transfer to cobas PCR media)
  • Frozen urine is not acceptable

 

Additional Information

Assay Limit of Detection

Plasma: 21.5 IU/mL

Urine: 12.2 IU/mL

Assay Quantitative Range

Plasma: 21.5 IU/mL - 100,000,000 IU/mL

Urine: 200 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.

Reference Values

Not Detected.

Specimen Transport Instructions

Whole blood specimens and unpreserved urine specimens should be delivered to the BJH MID laboratory within 24 hours of collection for processing. See Specimen Stability Information for handling of urine specimens.