The eazyplex® TyphiTyper is a qualitative in vitro diagnostic medical device for the detection of clinically relevant serovars of Salmonella enterica in bacterial colonies.
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.
- 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.
