Transplant Pathogen Monitoring

BKV ELITe MGB® Kit

BK Virus (BKV) is a highly prevalent and asymptomatic polyomavirus in the general population, and a major cause of renal infection in immunocompromised patients. Latent BKV is frequently reactivated after kidney and hematopoietic stem cell transplantation, leading to renal dysfunction and potentially graft loss. BKV viral load monitoring is crucial for patient management in order to prevent renal diseases and transplant failure.

BKV ELITe MGB® Kit is a real-time PCR assay designed for the detection and quantification of BK virus DNA. The assay is CE-IVD validated on diverse range of sample types, in combination with ELITe InGenius®, a fully automated sample-to-result solution.

Benefits

Conserved targets · Region of BK virus large T antigen gene and human beta-globin gene as an internal control
Easy-to-use · Monoreagent, ready-to-use
Best-in class PCR technology · ELITe MGB probes designed with Minor Groove Binder, Superbases® and Eclipse® Dark Quencher
Samples · Plasma and urine
Integrated workflow · Fully automated process for extraction, amplification and result analysis with ELITe InGenius
High performance · 100% clinical sensitivity and 97% clinical specificity
Quantitative result · International units (IU/mL) correlated to the 1st WHO International standard for Human BKV for NAAT (NIBSC Code 14/212)
· Copies/mL (cp/mL)
Storage of standard curve · 60 days
Eluate storage · Additional testing including multiple PCR from the same eluate, retesting or archiving
Minimal hands-on time · Less than 2 minutes per sample from extraction to result analysis
Complete transplant menu · Complete transplant pathogen monitoring range

 

Ordering Information

Product Name Description Reference
BKV ELITe MGB Kit 4 tubes, 24 reactions each RTS175PLD
BKV ELITe Standard 2 sets of 4 levels, 8 reactions each STD175PLD
BKV ELITe Positive Control 2 tubes, 4 reactions each CTR175PLD
CTRCPE – Internal Control 4 tubes, 12 reactions each CTRCPE

 

BKV ELITe MGB Kit is also CE-IVD validated with other systems