02 Details

Pneumocystis ELITe MGB® Kit

Pneumocystis pneumonia (PCP) is an opportunistic disease caused by invasion of the unicellular fungus Pneumocystis jirovecii (PJ). In lungs PJ exists in trophic and cystis form and it is one of the most frequent and severe opportunistic infections in people with weakened immune systems. PCP a major cause of morbidity and mortality among HIV-infected patient, nowadays reduced with ART, moreover, represents a significant cause of increasing mortality among HIV-negative patients who are immunosuppressed. For non-immunosuppressed individuals fungal invasion usually leads to asymptomatic colonization. Without treatment, PCP can cause death. Prompt and specific diagnosis is crucial to improve patient outcome. Pneumocystis ELITe MGB® Kit is a quantitative PCR assay for the detection and quantification of the DNA e detection and the quantification of the DNA of Pneumocystis jirovecii (PJ) in DNA samples extracted from clinical specimens. The assay is CE-IVD validated in combination with ELITe InGenius® , a fully automated sample-to-result solution.

Benefits

Conserved sequences
  • The mitochondrial large subunit of rRNA gene (mtLSU) of PJ and IC2 artificial DNA sequence as an internal control
Eluate storage
  • 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
  • Bronchial aspirate (BA) and sputum
Integrated workflow
  • Fully automated process including extraction, amplification and result analysis with ELITe InGenius
High performance
  • 97% clinical sensitivity and 100% clinical specificity
Quantitative results
  • 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 menu
  • Complete respiratory Infections range and transplanted pathogens monitoring

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