eazyplex® MRSA is a qualitive in vitro diagnostic medical device for the detection of specific nucleic acid sequences of MRSA (Methicillin-resistant Staphylococcus aureus) from swabs (nasal/ pharyngeal, or wound), bacterial colonies and positive blood cultures.
The test can be performed any time by trained professional laboratory personnel in a medical diagnostic laboratory. The test is to be first performed manually (test preparation) 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:
- Screening of asymptomatic patients via nasal/ pharyngeal, 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, the test is not the sole determinant) of all kind of patients via testing bacterial colonies as well as positive blood cultures.
The following protective mechanisms prevent the use of false results:
- Performance of “inhibition control” with each sample prevents 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. Via detection of the human ß-globin gene by means of “sample control” it is verified that (sufficient) human epithelial cells have been present on the swab. This can be used as quality criterion of sample taking. This control remains negative in the case of testing bacterial colonies and blood culture samples.
- 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.
