BK Virus (BKV) DNA, Quantitative PCR, Plasma
Test Mnemonic
BKQUAN
CPT Codes
- 87799 - QTY (1)
LOINC ®
41479-7
Aliases
- BKQUAN
- SQBKQUAN
- viral load
- BKVAN
- polyomavirus
- PVAN
- BKV DNA
- BKVDNA
Includes
- BKV DNA
- Plasma BKV DNA (IU/mL)
- Plasma 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 |
|---|---|---|---|---|---|
| 2 mL | Plasma | EDTA PPT (White) | Centrifuge and refrigerate. | Collect EDTA plasma according to standard protocol. Separate plasma by centrifugation (at 1,100 RCF for a minimum of 10 minutes) within 24 hours of collection. Plasma must be aliquoted first if sample is to be frozen. Sample cannot be shared with a test performed outside of Molecular Microbiology. Sample can only be shared with CMVQNT, HCQPCR, HIVRNA, HBVDNU, EBVQNT, or BKQUAN. |
Alternate Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 2 mL | Plasma | EDTA (Lavender) | Centrifuge, aliquot and refrigerate ASAP. | Collect EDTA plasma according to standard protocol. Centrifuge (at >1300 RCF for a minimum of 10 minutes) and aliquot into a sterile secondary tube within 24 hours of collection. Plasma must be aliquoted first if sample is to be frozen. Sample cannot be shared with a test performed outside of Molecular Microbiology. Sample can only be shared with CMVQNT, HCQPCR, HIVRNA, HBVDNU, EBVQNT, or BKQUAN. | |
| 2 mL | Plasma | Pink KEDTA | Centrifuge and refrigerate. | Collect EDTA plasma according to standard protocol. Centrifuge (at >1300 RCF for a minimum of 10 minutes) and aliquot into a sterile secondary tube within 24 hours of collection. Plasma must be aliquoted first if sample is to be frozen. Sample cannot be shared with a test performed outside of Molecular Microbiology. Sample can only be shared with CMVQNT, HCQPCR, HIVRNA, HBVDNU, EBVQNT, or BKQUAN. |
Minimum Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 1 mL | Minimum volume for testing is 1.0 mL of plasma. Aliquots must be made from specimen prior to testing in any lab outside of Molecular Microbiology, and must be placed in a sterile aliquot tube. |
Stability
| Environmental Condition | Description |
|---|---|
| Refrigerated | 6 days for plasma separated from whole blood within 24 hours; 24 hours for whole blood unspun/unseparated |
| Frozen | 6 months for plasma if separated from whole blood and aliquoted into a secondary tube within 24 hours (plasma cannot be frozen in PPT tubes) |
| Ambient | 24 hours for plasma or for whole blood unspun/unseparated |
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
BKQUAN should only be utilized for EDTA plasma. For urine, utilize UBKQT.
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 EDTA plasma is 21.5 to 100,000,000 IU/mL (1.33 - 8.00 log IU/mL). The lower limit of detection of the assay in EDTA plasma is 21.5 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.