The eazyplex® SuperBug basic test system is a qualitative in vitro diagnostic medical device for the detection of bacteria that are capable, from a genetic stand-point, of producing certain carbapenemases.
eazyplex® SuperBug basic detects all described variants of carbapenemases of the VIM-, NDM-, KPC-type, and the OXA-48 family including OXA-181/-232
The intended purpose of the test includes:
- Screening of asymptomatic patients via rectal swabs.
- Diagnosis (confirmatory assay to verify results of previous testing) and aid to diagnosis (providing additional information to assist in the determination or verification of a patient's clinical status, wherein the test is not the sole determinant) of all kinds of patients via testing of bacterial colonies.
Protective mechanisms preventing 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.