The following kits are available:
- eazyplex® CSF direct, for determination of HSV-1, HSV-2, VZV, N. menigitidis, S. pneumoniae, S. alagactiae, L. monocytogenes.
- eazyplex® CSF direct M, for determination of N. meningitidis, S. pneumoniae, S. agalacitae, L. monocytogenes, H. influenzae and E. coli.
- eazyplex® CSF direct V, for determination of HSV-1, HSV-2 and VZV.
Intended purpose of the test:
- The eazyplex® CSF direct test system is a qualitive in vitro diagnostic medical device for the detection of infectious agents (bacteria and viruses) in cerebrospinal fluid which may cause inflammations of the central nervous system.
- The test can be performed at any time by qualified professional staff in a medical laboratory. The intended purpose includes aid to diagnosis (providing addtional information to assist in the determination or verification of a patients' clinical status, test is not the sole determinant) of all kind of patients via testing cerebrospinal fluid.
Protective mechanisms to 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 reagents control.
- The test result is only displayed if the inhibition control is valid.
- As required, a test strip can be processed as a negative/ contamination control by testing MA-RS without addition of sample material. In this case, only the inhibition control is allowed to create a positive signal.