The eazyplex® VRE basic panel is a qualitive in vitro diagnostic medical device for the detection of specific nucleic acid sequences of VRE (Vancomycin-resistant enterococci) from bacterial colonies, as well as from positive blood cultures.
The test is first perfomed manually (test preparation) by professional trained laboratory personnel, and then automatically in combination with a Genie II MK2 or Genie HT device (amplification process and measurement).
The intended purpose of the test includes:
- Diagnosis (confirmatory assay to verify results of previous testing) and aid to diagnosis (providing addtional 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 baterial colonies, as well as positive blood cultures.
Protective mechanisms to prevent the use of false results:
- Performance of a "inhibition control" with each sample preventing the use of false negative test results due to inhibition of the amplification reaction and simultaneously serves 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.
