Test Highlight: New Tests Live February 21, 2023
|Test Code||Test Name|
|3006076||BK Virus by Quantitative NAAT, Plasma|
|3006075||BK Virus by Quantitative NAAT, Urine|
BK virus is a human polyoma virus. Following initial infection, the virus remains latent in many tissues, including tissues in the kidney and possibly the brain. If a person has a weakened immune system, the virus can reemerge.1 A weakened immune system and the use of immunosuppressive drugs due to organ transplantation are the main risk factors for a reemergent BK virus infection.
Screening for BK virus is important for the early identification of reactivated infection.2 Timely detection and quantification of the viral load are especially important in the care and treatment of certain immunocompromised patients. To assist in the detection of BK virus infections, ARUP now offers FDA-cleared assays for the quantification of BK virus DNA in plasma and urine specimens.
Benefits of the New Tests
- The FDA-cleared assays support the standardization of BK virus results across the laboratory industry to optimize treatment.
- Results will now be reported in international units (IU) instead of copies.
- Transition to FDA-cleared assays supports more stringent vendor quality, which works hand in hand with ARUP’s overall quality plan.
- The tests involve defined specimen types, which aids in patient monitoring.
- Testing that is FDA-approved is easier to bill to Medicare. You will no longer need to submit an additional code on claims to be reimbursed for this testing. Also, insurance reimbursement is more consistent for FDA-approved tests.
Frequently Asked Questions
What are the differences between the inactivated BK virus tests and the new BK virus by quantitative NAAT tests?
BK Virus, Quantitative PCR, 0090067
BK Virus, Quantitative PCR, Blood, 2002304
BK Virus, Quantitative PCR, Urine, 2002310
BK Virus by Quantitative NAAT, Plasma, 3006076
BK Virus by Quantitative NAAT, Urine, 3006075
|Reference range||2.6–8.6 log copies/mL
|1.33–8.00 log IU
|2.30–8.00 log IU
|TAT||1–3 days||1–3 days||1–3 days|
|Sample types||Plasma, whole blood, serum, urine||Plasma||Urine in cobas PCR urine sample tube (ARUP supply #58056 PK/100 or #58084 PK/10)|
|Sample stability||Ambient: 24 hours
Refrigerated: 5 days
Frozen: 1 year
Refrigerated: 6 days
Frozen: 6 months
|Ambient: 90 days
Refrigerated: 90 days
|Sample volume||1 mL||2 mL||Liquid level must be between the black fill lines on the tube|
Which genotypes are detected by the 3006076, BK Virus by Quantitative NAAT, Plasma, and 3006075, BK Virus by Quantitative NAAT, Urine assays?
The tests detect BK virus genotype subtypes I (with subgroups Ia, Ib, and Ic), II, III, and IV.
I would like to submit a specimen source other than plasma or urine. What should I order?
Only plasma (3006076, BK Virus by Quantitative NAAT, Plasma) and urine (3006075, BK Virus by Quantitative NAAT, Urine) are acceptable specimen sources. These specimen sources are FDA-approved for these assays.
What are the specimen requirements for urine specimens?
Collect urine and transfer immediately to the cobas PCR urine sample tube (ARUP supply #58056 PK/100 or #58084 PK/10) available online through eSupply using ARUP Connect™ or by contacting Client Services at 800-522-2787.
I am tracking my patient’s viral load. Is there a need to rebaseline?
Based on verification studies, one IU/mL of BK DNA measured by the new FDA-cleared BK molecular assays (test codes 3006076 and 3006075), is approximately equal to 1.37 copies/mL reported by the previous laboratory-developed tests (test codes 0090067, 2002304, 2002310). This conversion factor between IU/mL and copies/mL was established during verification of 3006076 BK Virus by Quantitative NAAT, Plasma, and 3006075 BK Virus by Quantitative NAAT, Urine.
- Holt DA, Sinnott JT 4th, Oehler RL, et al. BK virus. Infect Control Hosp Epidemiol. 1992;13(12):738–741.
- Sawinski D, Goral S. BK virus infection: an update on diagnosis and treatment. Nephrol Dial Transplant. 2015;30(2):209–217.