Carbapenemase-generating Enterobacteriaceae lyphilized RTU qPCR CE/IVD

Intended Use:
Vitassay qPCR Carbapenemase-generating Enterobacteriaceae allows the qualitative detection and differentiation of the main carbapenemase-encoding genes (NDM, VIM, OXA, KPC and/or IMP) by real-time PCR directly from rectal swabs and from bacterial isolates of clinical samples. The product is intended for use in the diagnosis of carbapenem-resistant Enterobacteriaceae infections alongside the patient’s clinical data and other laboratory tests outcomes.

Vitassay qPCR Kits contains in each well enzymes, buffer, primer and probes as well as an internal control in a lyophilized format.
The kits include a positive and a negative control.

Identification of pathogen DNA or RNA occurs by the use of target specific primers ans fluorecent labeled hydrolysis probes which hybridize conserved regions in the genomes of the different pathogens.

Kit Content:
- Carbapenemase-generating Enterobacteriaceae I strips low/high profile
- Carbapenemase-generating Enterobacteriaceae II strips low/high profile
- Carbapenemase-generating Enterobacteriaceae Positive Control (red vial): 1 vial
- PCR grade water (white vial): 1 vial
- Resuspension Buffer (green vial): 1 vial x1 mL
- Negative control (yellow):1 vial x 1 mL
- Optical caps: 8x8 cap strip
- For quantitative assay: target specific standard

Kit Format:
qualitative