CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Feb. 12, 2021–Roche announced FDA 510(k) clearance of stabilized urine samples to be used with the Cobas BKV test on the Cobas 6800/8800 systems.
The Cobas BKV test is a real-time polymerase chain reaction test with dual-target technology that provides quantitative accuracy and guards against the risk of sequence variations that may be present in the BK virus. Urine stabilized in Cobas PCR media has a limit of detection of 12.2 IU/mL and a linear range from 200 IU/mL to 1E+08 IU/mL.
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