Test Overview
Test Methodology

Polymerase Chain Reaction (PCR)

Test Usage

Intended for use as an aid in the management of BKV in transplant patients. In patients undergoing monitoring of BKV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment.

Reference Range *

Not detected

* Reference ranges may change over time. Please refer to the original patient report when evaluating results.

Test Limitations

BKV test results should be interpreted in the context of other clinical data and should not be the sole basis for treatment decisions.
Mutations within the target regions of cobas® BKV could affect primer and/or probe binding resulting in the under-quantitation of virus or failure to detect the presence of virus.
Due to the potential for variability in BKV DNA measurements across different BKV assays, it is recommended that the same device (Same laboratory) be used for the serial quantitation of BKV DNA when managing individual patients.

Test Details
Days Set Up
Monday, Wednesday, Friday
Analytic Time

6 hours

Soft Order Code
QBKV
MiChart Code
BK Virus DNA, Quantitative, Plasma
Synonyms
  • BK Viral Load
  • BK Virus DNA Quantitaion
  • BKV Viral Load
  • Viral Load BK (BKV)
Laboratory
Microbiology
Section
Microbiology
Specimen Requirements
Collection Instructions

Collect specimen in a lavender top (EDTA) tube. Centrifuge for 20 minutes at 800 - 1600 xg at room temperature and aliquot plasma into a polypropylene plastic vial within 24 hours of collection. Refrigerate for up to 6 days or freeze for longer storage. Do not allow frozen specimens to thaw at any time during storage or transport, due to possible degradation of the DNA. Specimens submitted in polystyrene tubes are not acceptable. Specimens sent for Microbiology molecular testing require a dedicated sample and cannot be shared with other laboratories.

Normal Volume
4 mL whole blood or 2 mL EDTA plasma
Minimum Volume
2 mL whole blood or .5 mL EDTA plasma
Storage Temperature
Plasma samples separated from whole blood within 24 hours of collection may be stored and/or transported for up to 6 days at 2-8°C or up to 12 weeks at-20°C±2°C.For long-term storage up to 6 months, temperatures at-75°C±15°C are recommended.
Rejection Criteria
Specimens received in polystyrene aliquot tubes are unacceptable and will be rejected. Plasma must be removed from cells in 24 hours of collection.
Additional Information

The lower limit of detection is 21.5 IU/mL (1.33 log IU/mL). The quantitative range of this assay is 21.5 IU/mL to 10,000,0000 IU/mL (1.33 to 8 LOG10).
Guidelines based on the precision of PCR tests suggest that the changes in serial viral load measurements should be at least 3-fold (0.5 log10) to represent biologically important changes. For viral loads near the lower limit of detection, measurements may need to be greater than 5-fold (0.7 log10) to be significant. Virus present below 21.5 IU/ mL will be reported as detected but not quantified. If results are greater than 100,000,000 IU/mL a dilution of the sample will be run for an exact quantitation. For Mlabs, please contact client service center if actual viral load is needed.

Billing
CPT Code
87799
Fee Code
LA019
LOINC
44805-0
NY State Approved
No