This assay is an in vitro nucleic acid amplification test for the quantification of BKV DNA in urine stabilized in cobas urine PCR Media. It is intended for use to aid in the management of BKV in transplant patients. An interpretation of "Not Detected" does not rule out the presence of inhibitors or BK virus DNA concentrations below the level of detection by the assay. Care should be taken in the interpretation of any single viral load determination.