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UWHC Lab Test Details | |
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Test Name | BK Virus, Quantitative by PCR, Urine |
Test Code(s) | HCBKPCR |
CPT Code(s) | 87799 |
Methodology | Real-Time PCR |
Clinical Information | Detect and quantify BK virus in urine. |
Days Performed | Mon-Fri. |
In-Lab Turnaround Time | 2 - 3 days. |
Stat In-Lab Turnaround Time | Not available stat. |
Collection Requirements | |||
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Patient Preparation | Testing is performed Monday-Friday in batched runs. Specimens received by the Molecular Diagnostic lab by 8:30am will be run same day. If received after 8:30am it will be held to following day. | ||
Specimen | Random urine | ||
Collection Container |
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Collection Instructions | First morning void is preferred. | ||
Collection Volume | 5 - 10 mL | ||
Pediatric Collection Volume | 2 mL |
Specimen Processing Requirements | |||||||
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Stability |
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Sample Analyzed | Urine aliquot | ||||||
Testing Volume | 2 mL | ||||||
Pediatric Testing Volume | 1.2 mL | ||||||
Specimen Transport | Transport specimen to Laboratory. |
Interpretation | |
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Test Limitations | Analytical Measurement Range is 200 IU/mL to 1 x 109 IU/mL (2.30-9.00 log10 IU/mL) of urine. Inadequate specimen collection, processing and storage may invalidate test results. This test should not be used as the only criterion to form a clinical conclusion; instead, results should be correlated with other test results, patient symptoms and clinical presentation. |
Additional Information | For urine samples in which BKV DNA is detected and between the analytical measurement range (AMR) of 200 IU/mL to 1 x 109 IU/mL (2.30-9.00 log10 IU/mL) of urine, a quantitative value (IU/mL or log IU/mL) will be reported. If BKV DNA is detected outside the analytical measurement range (AMR) a result for <200 IU/mL or>1 x 109 IU/mL will be reported. If BKV DNA is not detected, a result of "Not Detected" will be reported.
A result of "Not Detected" does not rule out the presence of BKV DNA or the absence of infection. False negative results may be due to the suppression of viral replication to levels below the detection threshhold, or to inhibitory substances that may be present in the specimen.
The performance characteristics of this test were validated by UWHC Clinical Laboratories. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test; however, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. The UWHC Clinical Laboratories is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing. |