DiAGSure® BK Virus Quantitative Kit (TaqMan based)

Intent to Use:
BKV, a small double-stranded DNA virus from the Polyomaviridae family, is highly prevalent in the general population and typically remains latent in the renal epithelium. In immunocompromised individuals, particularly kidney and hematopoietic stem cell transplant recipients, viral reactivation can lead to serious complications such as BKV-associated nephropathy (BKVAN) and hemorrhagic cystitis. The DiAGSure® BK Virus Quantitative Kit is a real-time PCR-based diagnostic tool for the detection and quantification of BK polyomavirus (BKV) DNA in clinical specimens which enables accurate measurement of BKV viral load, with high sensitivity and specificity, facilitating early diagnosis and real-time monitoring of infection. This supports timely therapeutic interventions and helps reduce the risk of graft dysfunction, allograft loss, and associated morbidity in transplant patients.

Key Specifications:
 Accurate detection and quantification BKV with results traceable to the 4th WHO International Standard (NIBSC code: 14/212).
 Exceptional Sensitivity & Specificity with analytical sensitivity with CE-IVD certification.
 The multiplex qPCR assay offers a rapid, simple, and affordable method for the early detection.
 Meticulous design prevents detection failures from mutations and Robust Internal Control to prevent false negatives.
 Ready-to-Use Workflow and no post-PCR handling minimizes error and contamination risk.
 Compatible with major real-time PCR instruments.

Sample types:
Human Plasma, Serum, whole blood, tissue biopsy and other body fluids.

Product information: