BK Virus (BKV) DNA, Quantitative PCR, Urine
Test Mnemonic
UBKQT
CPT Codes
- 87799 - QTY (1)
LOINC ®
41480-5
Aliases
- SQUBKQT
- UBKQT
- viral load
- BKVAN
- polyomavirus
- PVAN
- BKV DNA
- BKVDNA
Includes
- BKV DNA
- Urine BKV DNA (IU/mL)
- Urine BKV DNA (log IU/mL)
Performing Laboratory
Cleveland Clinic Laboratories
FDA Category
In Vitro Diagnostic
Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 5 mL | Urine, random | Sterile container | Refrigerated | Collect or transfer 5 mL of urine into a sterile, plastic, preservative-free container. Specimen must be transferred into cobas PCR Urine Sample Kit within 24 hours of collection. The correct volume of urine has been added when the fluid level is between the two black lines on the tube label. |
Minimum Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 1 mL | The minimum volume of urine accepted is 1 mL. |
Stability
| Environmental Condition | Description |
|---|---|
| Ambient | 24 hours for neat urine; 90 days for urine stabilized in cobas PCR media |
| Refrigerated | 24 hours for neat urine; 90 days for urine stabilized in cobas PCR media |
Days Performed
7 days a week
Turnaround Time
1 - 3 days
Methodology
| Name | Description |
|---|---|
| Polymerase Chain Reaction (PCR), Quant |
Reference Range
| BKV DNA | |||||
|---|---|---|---|---|---|
| Sex | Age From | Age To | Type | Range | Range Unit |
| Normal | Not detected |
Special Info
UBKQT should only be utilized for urine. For EDTA plasma, utilize BKQUAN.
Clinical Info
BK virus (BKV) is a common viral pathogen that can cause polyoma virus nephropathy in kidney transplant patients. It is also associated with hemorrhagic cystitis in immunocompromised patients, especially in hematopoietic stem cell transplant recipients. cobas BKV is an FDA-approved in vitro nucleic acid amplification test for the quantitation of BK virus (BKV) DNA in human EDTA plasma and urine stabilized in cobas PCR Media. In EDTA plasma, cobas BKV is intended for use as an aid in the management of BKV in transplant patients. In patients undergoing monitoring of BKV in EDTA plasma, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment. In urine stabilized in cobas PCR Media, cobas BKV is intended for use as an aid in the management of BKV in transplant patients. The results from cobas BKV are intended to be read and analyzed by a qualified licensed healthcare professional in conjunction with clinical signs and symptoms and relevant laboratory findings. Test results must not be the sole basis for patient management decisions. The assay is a quantitative PCR assay that targets highly-conserved regions of the BKV located in the BKV small t-antigen region and the BKV VP2 region, and is reported out in international units (IU/mL). The linear range of the assay in urine is 200 to 100,000,000 IU/mL (2.30 - 8.00 log IU/mL). The lower limit of detection of the assay in urine is 12.2 IU/mL.
Clinical Limitation
For full limitations, refer to the assay instructions for use available on the manufacturer's website. The most important limitations are summarized as follows. Recommendations regarding monitoring BKV viral load post-transplant and medically relevant BKV DNA thresholds vary among transplant type and transplant institutions. As with any molecular test, 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 be used for the serial quantitation of BKV DNA when managing individual patients.
Clinical Reference
1. Hirsch HH, Randhawa PS; AST Infectious Diseases Community of Practice. BK polyomavirus in solid organ transplantation-Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019 Sep;33(9):e13528. doi: 10.1111/ctr.13528. Epub 2019 Apr 10. PMID: 30859620. 2. U.S. Food and Drug Administration (FDA). 510(k) Substantial Equivalence Determination Decision Summary K203220. Accessed July 5, 2024. https://www.accessdata.fda.gov/cdrh_docs/reviews/K203220.pdf.