Test Catalog

Test Id : UBKQN

BK Virus DNA Detection and Quantification, Random, Urine

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detection and serial monitoring of BK virus (BKV) virus-associated nephropathy in kidney transplant recipients using random urine specimens

 

Detection and serial monitoring of BKV-associated hemorrhagic cystitis in organ transplant recipients

Highlights

This assay detects and quantifies the level of BK virus (BKV) DNA present in the urine of kidney transplant recipients who are at risk of developing BKV-associated nephropathy or hemorrhagic cystitis leading to decreasing renal function and eventual renal failure. The assay is calibrated to the First World Health Organization International Standard for BKV DNA.

Method Name
A short description of the method used to perform the test

Real-Time Polymerase Chain Reaction (rtPCR)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

BKV DNA Detect/Quant, U

Aliases
Lists additional common names for a test, as an aid in searching

BK viral load

BK virus by PCR

BK virus DNA quant

BKV by PCR

BKV DNA quant

BKV viral load

Specimen Type
Describes the specimen type validated for testing

Urine

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: cobas PCR Urine Sample Kit (T903)

Container/Tube: cobas PCR urine tube

Specimen Volume: 4.3 mL

Collection Instructions:

1. Collect a random urine into a sterile, plastic, preservative-free container.

2. 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 at Mayo Clinic Laboratories.

3. Transport and store urine specimen transport container at 2 to 30 degrees C (refrigerate is preferred temperature).

Additional Information: cobas PCR media contains guanidine hydrochloride. Do not allow these tubes to come in direct contact with sodium hypochlorite (bleach) or other highly reactive reagents such as acids and bases. These mixtures can release a noxious gas.

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244)with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

See Specimen Required

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Urine Refrigerated (preferred) 84 days COBAS PCR URINE
Ambient 84 days COBAS PCR URINE

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detection and serial monitoring of BK virus (BKV) virus-associated nephropathy in kidney transplant recipients using random urine specimens

 

Detection and serial monitoring of BKV-associated hemorrhagic cystitis in organ transplant recipients

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

BK virus (BKV) is a circular, double-stranded DNA virus with an approx. 5 kilobase-size genome in the polyomavirus family, of which 13 members of the family are known, including the JC virus (JCV) and SV40. BKV shares about 75% of its DNA sequence with JCV. Nearly 80% of the adult population worldwide have antibodies to both viruses, indicating previous infection or exposure to these viruses.

 

Initial infection with BKV is usually acquired in childhood, mostly asymptomatic or manifesting as a mild flu-like illness.  After primary infection, BKV establishes latency in the kidney and bladder of the infected individual. In the setting of immunosuppression, the virus reactivates and begins to replicate, triggering renal tubular cell lysis and viruria. As the reactivation progresses, the virus multiplies and crosses into the bloodstream, causing viremia and invading the kidney graft. In patients with kidney transplants, reactivation of BKV typically reaches peak incidence at 3 months post-transplantation with BK viral replication in the kidney graft, causing BKV-associated nephropathy (BKVAN), which manifests as kidney dysfunction that may result in eventual loss of the transplanted kidney. Reactivation of BKV in the bladder can lead to hemorrhagic cystitis. Currently, there is no FDA-approved antiviral agent or treatment for BKVAN or BKV-associated hemorrhagic cystitis, and the main treatment is to decrease the immunosuppression, with the risk of acute rejection of the kidney graft.

 

After BK reactivation, the virus is first detectable in the urine, with viremia developing several weeks later. Quantitative BKV DNA in the plasma is the most widely used and preferred test for the laboratory diagnosis of BKVAN and BKV-associated hemorrhagic cystitis, as BKV viremia has higher positive predictive value (50%-60%) than BKV viruria for the diagnosis of BKVAN. Serial monitoring of BKV DNA level in plasma is recommended to guide optimal immunosuppressant dosing regimen. In those with BKVAN, clearance of BK viremia is a sign of resolution of the nephropathy.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Undetected

Interpretation
Provides information to assist in interpretation of the test results

The quantification range of this assay is 200 to 100,000,000 IU/mL (2.30 log to 8.00 log IU/mL), with a limit of detection (95% detection rate) at 12 IU/mL.

 

An "Undetected" test result indicates the absence of BK virus (BKV) DNA in the urine.

 

A test result of "<200 IU/mL (<2.30 log IU/mL)" indicates that BKV DNA is detected in the urine, but the assay cannot accurately quantify the BKV DNA present below this level.

 

A quantitative value (reported in IU/mL and log IU/mL) indicates the level of BKV DNA (ie, viral load) present in the urine.

 

A test result of ">100,000,000 IU/mL (>8.00 log IU/mL)" indicates that BKV DNA level present in urine is above 100,000,000 IU/mL (8.00 log IU/mL), and the assay cannot accurately quantify BKV DNA present above this level.

 

An "Inconclusive" result indicates that the presence or absence of BKV DNA in the urine specimen could not be determined with certainty after repeat testing in the laboratory, possibly due to polymerase chain reaction inhibition or presence of interfering substance. Submission of a new specimen for testing is recommended if clinically indicated.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

On average, quantitative BK virus (BKV) DNA results in urine tested with this assay can be up to 3.5-fold (about 0.54 log IU/mL) higher than those generated from the previous laboratory-developed BKV DNA quantification assay performed at Mayo Clinic Laboratories, due to differences in the specimen extraction method and design in the amplification primers and probes for the viral target sequences.

 

A single "Undetected" test result does not necessarily rule out the presence BKV infection or reactivation. Serial measurement (eg, once weekly) of BKV DNA in urine or plasma is recommended to determine the BKV replication status in a given transplant recipient.

 

While unlikely to be present in urine specimens, vaginal lubricants, speculum jellies, creams, and gels containing carbomers may interfere with the test and should not be used during or prior to sample collection. Urogenital specimens from patients who have used carbomer-containing products such as Replens Long-Lasting Vaginal Moisturizer, RepHresh Odor Eliminating Vaginal Gel and RepHresh Clean Balance or used metronidazole vaginal gel may generate invalid or false-negative results.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Bechert CJ, Schnadig VJ, Payne DA, Dong J: Monitoring of BK viral load in renal allograft recipients by real time PCR assays, Am J Clin Pathol. 2010;133:242-250. doi: 10.1309/AJCP63VDFCKCRUUL

2. Hirsch HH, Randhawa P, AST Infectious Diseases Community of Practice: BK polyomavirus in solid organ transplantation. Am J Transplant. 2013; 13(Suppl 4):179-188. doi: 10.1111/ajt.12110

3. 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;33:e13528. doi: 10.1111/ctr.13528

4. Muhsin SA, Wojciechowski D: BK virus in transplant recipients: current perspectives. Transplant Research and Risk Management. 2019:11:47-58. doi: 10.2147/TRRM.S188021

Method Description
Describes how the test is performed and provides a method-specific reference

The cobas BK virus (BKV) assay is an FDA-approved, in vitro nucleic acid amplification test for the quantification of BKV DNA using either the cobas 6800 or 8800 system for fully automated viral nucleic acid extraction (generic silica-based capture technique) and automated amplification and detection of the viral RNA. This dual-target polymerase chain reaction (PCR) assay amplifies 2 highly conserved target regions within the BKV genome (small t-antigen and VP2 regions) for real-time detection and quantification by 2 target-specific TaqMan probes. A non-BKV armored DNA quantitation standard (DNA-QS) is introduced into each specimen during sample preparation to serve as internal control for nucleic acid extraction and PCR amplification and detection processes. Fluorescent reporter dye-labeled TaqMan probes hybridized to the complementary BKV target sequences and DNA-QS sequence undergo hydrolysis during PCR amplification step to generate fluorescent signal detected in 3 different dye channels. Concentration of the BKV DNA in a patient's sample is determined by a ratio of the intensity of the fluorescent dye from the cleaved BKV target sequence probes to that of the DNA-QS target probe detected throughout the PCR process.(Package insert: cobas BKV - Quantitative nucleic acid test for use on the cobas 6800/8800 Systems; Roche Molecular Systems; Doc rev 2.0, 02/2021)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87799

LOINC® Information

Test Id Test Order Name Order LOINC Value
UBKQN BKV DNA Detect/Quant, U 32285-9
Result Id Test Result Name Result LOINC Value
Result LOINC Value Tooltip
614568 BKV DNA Detect/Quant, U 32285-9

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports