The eazyplex® Candida auris is a qualitative in vitro diagnostic medical device for use in the detection of a specific nucleic acid sequence of Candida auris from skin or pharyngeal swabs, or yeast colonies via isothermal LAMP-method ("Loop-mediated isothermal AMPlification")
The intended purposes of the test includes:
- Screening of asymptomatic patients via skin or pharyngeal swabs.
- Aid to diagnosis of all kinds of patients via testing of yeast colonies.
Protective mechanisms to prevent the use of false results:
- Performance of "inhibition control" with each sample prevents the use of false negative test results, due to the inhibition of the amplification reaction whilst simultaneously serving as reagent control.
- The test result is only displayed if the inhibition control is valid.
- As required, a test strip can be processed as negative/ contamination control by testing RALF without addition of sample material. In this case, only the inhibition control is allowed to create a positive signal.