BK virus IVDs

Intended purpose

The Alinity m BKV is an in vitro nucleic acid amplification test for the quantitation of BK virus (BKV) DNA in human EDTA plasma and urine stabilized in transport buffer on the automated Alinity m System. The Alinity m BKV is intended for use as an aid in the management of BKV in transplant patients. The Alinity m BKV is not intended for use as a screening test for blood or blood products or human cells, tissues, and cellular and tissue-based products.