For urine samples in which BKV DNA is detected and between the analytical measurement range (AMR) of 500 copies/mL to 1 x 109 copies/mL (2.70-9.00 log10 copies/mL) of urine, a quantitative value (copies/mL or log copies/mL) will be reported. If BKV DNA is detected outside analytical measurement range (AMR) a result of <500 copies/mL or >1 x 109 copies/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. 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.
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.