eazyplex® hv-K.pneumoniae is a manual in vitro diagnostic medical device for the qualitative detection of specific nucleic acid sequences (DNA) of Klebsiella pneumoniae by means of LAMP technique ("loop-mediated isothermal amplification").
Detection is carried out from a single bacterial colony. eazyplex® hv-K.pneumoniae detects and differentiates the species Klebsiella pneumoniae, as well as different genes coding for virulence factors associated with hypervirulence of Klebsiella pneumoniae strains.
The intended purposes 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 to prevent 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.
- 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.
