For in vitro diagnostic use. Others cobas eplex BCID-FP panel IVD cobas® eplex blood culture identification fungal pathogen (BCID-FP) panel PID00000002 09 556 516 001 9 556 516 001 09556516001 9556516001 09556516001 cobas eplex BCID - FUNGAL 12T ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel 00857167005290 Reagents, kits EA005012 1 kit 12 tests true The cobas eplex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on cobas eplex Instrument for simultaneous detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture. The cobas eplex BCID-FP Panel is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system and which contain fungal organism.The following fungal organisms are identified using the cobas eplex BCID-FP Panel: Candida albicans, Candida auris, Candida dubliniensis, Candida famata, Candida glabrata, Candida guilliermondii, Candida kefyr, Candida krusei, Candida lusitaniae, Candida parapsilosis, Candida tropicalis, Cryptococcus gattii, Cryptococcus neoformans, Fusarium and Rhodotorula.The detection and identification of specific 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-FP 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-FP 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-FP Panel, susceptibility testing and differentiation of mixed growth) 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 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 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. en

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