OpGen Unyvero LRT BAL Cartridge Kit

Description

• 12 tests per kit; storage: 15-25°C Rapid, sample-to-answer results achieved with highly multiplexed automated closed-system PCR technology Panel consists of 30 targets (20 pathogens and 10 resistance genes) Panel includes atypical pathogens: Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, Pneumocystis jirovecii Panel covers several Urgent and Serious pathogens on CDC’s Antimicrobial Resistance Threat list: CRE Acinetobacter, CRE Enterobacterales, ESBL Enterobacterales, MDR P
• aeruginosa, MRSA Random access capability allows for on-demand testing Simple to use, fully barcoded cartridge-based technology enables testing during all laboratory shifts Only 2 minutes of hands-on time to set up a run Easy to train laboratory personnel to operate the Unyvero System Simultaneously detects a broad range of clinically relevant pathogens of hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) and community-acquired pneumonia (CAP) and their associated antibiotic resistance markers (AMR) in a single rapid test in just a few hours Direct from native sample testing provides faster results; days earlier than culture because no growth is required for detection with Unyvero molecular technology Faster and more sensitive than culture and traditional microbiological methods because results are not impacted by prior antibiotic use Excellent sensitivity and specificity provides higher diagnostic yield Detects more potential pathogens missed by culture, including multi-pathogen infections as well as pathogens not covered by empiric therapy Earlier targeted therapy can direct actionable life-saving antibiotic treatment decisions and decrease unnecessary use of antibiotics and their associated side effects, reduce costs, length of stay in the ICU, and spread of antimicrobial resistance (AMR) Clear, qualitative results based on defined cut-offs Moderate CLIA complexity Can be integrated into LIS (unidirectional) Pathogens (20): Acinetobacter spp., Chlamydia pneumoniae, Citrobacter freundii, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella variicola, Legionella pneumophila, Moraxella catarrhalis, Morganella morganii, Mycoplasma pneumoniae, Pneumocystis jirovecii, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Stenotrophomonas maltophilia, Streptococcus pneumoniae Resistance genes (10): Carbapenems: kpc, ndm, oxa-23, oxa-24, oxa-48, oxa-58, vim; 3rd Generation Cephalosporins: ctx-M; Oxacillin/Cefoxitin: mecA; Penicillin: tem