Search Results

The cobas vivoDx MRSA test performed on the cobas vivoDx System is an automated qualitative in vitro diagnostic test for the direct detection of live methicillin-resistant Staphylococcus aureus (MRSA) cells in nasal swab samples from patients who are at risk for nasal colonization by MRSA. The test utilizes selective agents and bioparticles (Smarticles technology) to introduce a luciferase gene into targeted bacteria to create an amplified luminescent signal in only viable (live) MRSA cells. The cobas vivoDx MRSA test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections, nor to guide, or monitor treatment. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing. The cobas vivoDx MRSA Collection and Transport Kit is used to collect, transport and store human nasal swab specimens for use with the cobas vivoDx MRSA test.

The cobas vivoDx MRSA test, performed on the cobas vivoDx Instrument, is an automated, phenotypic assay for the direct, qualitative detection of MRSA in nasal swab specimens that are collected and transported to the testing laboratory using the cobas vivoDx MRSA Collection and Transport Kit. Upon receipt in the laboratory, the test operator vortexes the specimen to elute the target organisms (if present) and transfers an aliquot of the transport medium to an MRSA Test Tube containing a dried bead of a selective reagent (cefoxitin) that is solubilized with the sample. The operator then applies a MRSA Reagent Cap to the Test Tube, briefly vortexes the assembled cartridge and loads it onto the cobas vivoDx Instrument for automated processing. The MRSA Reagent Cap comprises two reagent-filled blisters, one containing Staphylococcus aureus-specific bacteriophage-based Smarticles that encode the enzyme luciferase, and the other, a luminescent substrate. The cobas vivoDx Instrument automatically completes incubation of the cartridge, addition of the Smarticles and substrate to the test sample, as well as measurement and analysis of the luminescent signal. Results are reported as "Positive" (MRSA detected) or "Negative" (no MRSA detected).