Transplant Pathogen Monitoring

CMV ELITe MGB® Kit

Cytomegalovirus (CMV) is a highly prevalent herpesvirus in the general population and a leading cause of morbidity and mortality in immunocompromised patients. Latent CMV can be reactivated after solid organ or hematopoietic stem cell transplantation, and generate diverse and sometimes very severe infections. CMV diagnosis and viral load monitoring, especially by molecular methods, is important for patient management, in order to initiate and determine efficiency of anti-viral treatment.

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

Benefits

Conserved targets · CMV major immediate early antigene 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
Large range of samples · Whole blood, plasma, amniotic fluid, urine, cerebrospinal fluid and saliva
Integrated workflow · Fully automated process including 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 the1st WHO International standard for Human CMV for NAAT (NIBSC Code 09/162)
· Copies/mL (cp/mL)
Storage of standard curve · 30 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
CMV ELITe MGB Kit Monoreagent: 4 tubes, 24 reactions each
Standards: 1 set of 4 levels
Internal Control: 4 tubes, 12 reactions each
RTK015PLD
CMV ELITe Standard 1 set of 4 levels STD015PLD
CMV ELITe Positive Control 2 tubes, 6 reactions each CTR015PLD
CTRCPE – Internal Control 4 tubes, 12 reactions each CTRCPE

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