Gram-negative Nosocomial Agents II (P. aeruginosa, K. pneumoniae and P. mirabilis) lyophilised RTU qPCR CE/IVD

Intended Use:
Vitassay qPCR Gram-negative Nosocomial Agents II allows the qualitative detection and identification of DNA from Pseudomonas aeruginosa, Klebsiella pneumoniae and/or Proteus mirabilis by Real-Time PCR in blood culture and swab samples from patients with suspect of bacterial infection and/or multi-resistant infection or colonization and swabs specimens for epidemiological control by their healthcare professional. This product is intended to aid in the Pseudomonas aeruginosa, Klebsiella pneumoniae and/or Proteus mirabilis infections diagnosis, alongside the patient's clinical data, epidemiological risk factors, and other laboratory tests outcomes.
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:
- Gram-negative II strips low/high profile : 4 x 8-well strip
- Gram-negative II Positive Control: 1 vials
- PCR grade water (white vial): 1 vial
- Resuspension Buffer (green vial): 1 vial x1,8 mL
- Negative control (yellow): 1 vial x 1 mL
- Optical caps: 4x8 cap strip

Kit Format:
qualitative