For in vitro diagnostic use. Others cobas eplex BCID-GN panel IVD cobas® eplex blood culture identification gram-negative (BCID-GN) panel PID00000003 09 556 494 001 9 556 494 001 09556494001 9556494001 09556494001 GM EPLEX BCID GRAM NEG 12 TEST ePlex Blood Culture Identification Gram-Negative (BCID-GN) Panel 00857167005313 Reagents, kits EA002012 1 kit 12 tests true The cobas eplex blood culture identification gram-negative (BCID-GN) panel is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on the cobas eplex instrument for simultaneous qualitative detection and identification of multiple potentially pathogenic gram-negative bacterial organisms and select determinants associated with antimicrobial resistance in positive blood culture. In addition, the cobas eplex BCID-GN panel is capable of detecting several gram- positive bacteria (Pan Gram-Positive assay) and several Candida species (Pan Candida assay). The cobas eplex BCID-GN panel is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system and which contain gram-negative organism.The following bacterial organisms and genes associated with antibiotic resistance are identified using the cobas eplex BCID-GN panel: Acinetobacter baumannii, Bacteroides fragilis, Citrobacter, Cronobacter sakazakii, Enterobacter cloacae complex, Enterobacter (non-cloacae complex), Escherichia coli, Fusobacterium necrophorum, Fusobacterium nucleatum, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae group, Morganella morganii, Neisseria meningitidis, Proteus, Proteus mirabilis, Pseudomonas aeruginosa, Salmonella, Serratia, Serratia marcescens, Stenotrophomonas maltophilia, CTX-M (blaCTX-M ), IMP (blaIMP ) , KPC (blaKPC ) , NDM (blaNDM ), OXA (blaOXA ) (OXA-23 and OXA-48 groups only), and VIM (blaVIM ).The cobas eplex BCID-GN panel contains assays for the detection of genetic determinants associated with resistance to antimicrobial agents including CTX-M(blaCTX-M ), which is associated with resistance to extended spectrum beta-lactamase (ESBL)-mediated resistance to penicillins, cephalosporins, and monobactams, as well as OXA (blaOXA ) (OXA-23 and OXA-48 groups only), KPC (blaKPC ), and metallo- beta-lactamases IMP (blaIMP ), VIM (blaVIM ), and NDM (blaNDM ), which is associated with carbapenemase- mediated resistance. The antimicrobial resistance gene detected may or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance assays do not indicate susceptibility, as there are multiple mechanisms of resistance in gram-negative bacteria.The cobas eplex BCID-GN panel also contains targets designed to detect a broad range of organisms with a potentially misleading Gram stain result or organisms that may be missed by Gram staining altogether, for example in the case of co-infections. These include a broad Pan Gram-Positive assay (which is designed to detect Bacillus cereus group, Bacillus subtilis group, Enterococcus, Staphylococcus, and Streptococcus), as well as a Pan Candida assay, which is designed to detect four Candida species: Candida albicans, Candida glabrata, Candida krusei, and Candida parapsilosis.The detection and identification of specific bacterial and fungal nucleic acids from individuals exhibiting signs and/or symptoms of bloodstream infection aids in the diagnosis of bloodstream infection when used in conjunction with other clinical information. The results from the cobas eplex BCID-GN panel are intended to be interpreted in conjunction with Gram stain results and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Negative results in the setting of a suspected bloodstream infection may be due to infection with pathogens that are not detected by this test. Positive results do not rule out co-infection with other organisms; the organism(s) detected by the cobas eplex BCID-GN panel may not be the definite cause of disease. Additional laboratory testing (e.g. sub-culturing of positive blood cultures for identification of organisms not detected by cobas eplex BCID-GN panel and for susceptibility testing, differentiation of mixed growth, and association of antimicrobial resistance marker genes to a specific organism) and clinical presentation must be taken into consideration in the final diagnosis of bloodstream infection. en The True Sample-to-Answer Solution® cobas eplex Instrument automates all aspects of nucleic acid testing including extraction, amplification, and detection, combining electrowetting and GenMark’s eSensor® technology in a single-use cartridge. eSensor technology is based on the principles of competitive DNA hybridization and electrochemical detection, which is highly specific and is not based on fluorescent or optical detection. Electrowetting, or digital microfluidics, uses electrical fields to directly manipulate discrete droplets on the surface of a hydrophobically coated printed circuit board (PCB). Sample and reagents are moved in a programmable fashion in the cobas eplex cartridge to complete all portions of the sample processing from nucleic acid extraction to detection. A sample is loaded into the cobas eplex cartridge and the cartridge is placed into the cobas eplex Instrument. Nucleic acids are extracted and purified from the specimen via magnetic solid phase extraction. PCR is used to create double-stranded DNA, which is treated with exonuclease to create single-stranded DNA in preparation for eSensor detection. The target DNA is mixed with ferrocene-labeled signal probes that are complementary to the specific targets on the panel. Target DNA hybridizes to its complementary signal probe and capture probes, which are bound to gold-plated electrodes, as shown below in Figure 1. The presence of each target is determined by voltammetry which generates specific electrical signals from the ferrocene-labeled signal probe. Figure 1: Hybridization complex. Target-specific capture probes are bound to the gold electrodes in the eSensor microarray on the cobas eplex cartridge. The amplified target DNA hybridizes to the capture probe and to a complementary ferrocene-labeled signal probe. Electrochemical analysis determines the presence or absence of targets using voltammetry. en

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