For in vitro diagnostic use. Others cobas eplex BCID-GP panel IVD cobas® eplex blood culture identification gram-positive (BCID-GP) panel PID00000001 09 556 508 001 9 556 508 001 09556508001 9556508001 09556508001 GM EPLEX BCID GRAM POS 12 TEST ePlex Blood Culture Identification Gram-Positive (BCID-GP) Panel 00857167005320 Reagents, kits EA003012 1 kit 12 tests true The cobas eplex blood culture identification gram-positive (BCID-GP) panel is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on cobas eplex instrument for simultaneous qualitative detection and identification of multiple potentially pathogenic gram-positive bacterial organisms and select determinants associated with antimicrobial resistance in positive blood culture. In addition, the cobas eplex BCID-GP panel is capable of detecting a wide variety of gram-negative bacteria (Pan Gram- Negative assay) and several Candida species (Pan Candida assay). The cobas eplex BCID-GP panel is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system and which contain gram-positive organism. The following bacterial organisms and genes associated with antibiotic resistance are identified using the cobas eplex BCID-GP panel: Bacillus cereus group, Bacillus subtilis group, Corynebacterium, Cutibacterium acnes (Propionibacterium acnes), Enterococcus, Enterococcus faecalis, Enterococcus faecium, Lactobacillus, Listeria, Listeria monocytogenes, Micrococcus, Staphylococcus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus, Streptococcus agalactiae (GBS), Streptococcus anginosus group, Streptococcus pneumoniae, Streptococcus pyogenes (GAS), mecA, mecC, vanA and vanB. The cobas eplex BCID-GP panel contains assays for the detection of genetic determinants associated with resistance to methicillin (mecA and mecC) and vancomycin (vanA and vanB) to aid in the identification of potentially antimicrobial resistant organisms in positive blood culture samples. The antimicrobial resistance gene detected may or may not be associated with the agent responsible for disease. The cobas eplex BCID-GP 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-Negative assay as well as a Pan Candida assay, which is designed to detect four of the most prevalent 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-GP 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-GP 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-GP 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 blood stream 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 the 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 technology 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 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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