The eazyplex® VRE panel is a qualitive in vitro diagnositiv medical device for the detection of specific nucleic acid sequences of VRE (Vancomycin-resistant enterococci) from swabs (rectal or wound), bacterial colonies and positive blood cultures.
The test is first performed manually (test preparation) by professional trained laboratory personnel, and then automatically in combination with a Genie II MK2 or a Genie HT device (amplification process and measurement).
The intended purpose of the test includes:
- Screening of asymptomatic patients via rectal or wound swab.
- 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, wherin th e test is not the sole determinant) of all kinds of patients via testing of bacterial colonies, as well as positive blood cultures.
Protective mechanisms to prevent the use of false results:
- Performance of an "inhibition control" prevents the use of false negative test results due to the inhibition of the amplification reaction and simultaneously serves as reagent control.
- The test result is only displayed if the inhibition control is valid.
- Via the detection of human ß-globin gene by means of "sample control H" it is verified that (sufficient) human epithelial cells are present on the wound swab. This can be used as quality criterion of sample taking.
- Via detection of enterobacterial DNA by means of "sample control B" it is checked if a rectal swab has been taken correctly. This can be used as quality criterion of sample taking.
- 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.
