The eazyplex® SuperBug Acineto in a qualitative in vitro diagnostic medical device for use in the detection of Acinetobacter baumannii. Furthermore, the eazyplex® SuperBug Acineto detects all described variants of carbapenemases of the OXA-23, OXA-40, OXA-58 groups, as well as NDM.
The intended purpose of the test includes:
- 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.