BK virus IVDs

Intended purpose

The Panther Fusion™ BKV Quant assay is a fully automated real-time PCR (RT-PCR) in vitro nucleic acid amplification test for the quantitation of human BK virus (BKV) DNA in human plasma and urine samples. The Panther Fusion BKV Quant assay is intended for use to aid in the diagnosis and to aid in the management of solid-organ transplant patients and in hematopoietic stem cell transplant patients. This assay is designed for use on the Panther Fusion system.