NG CiproRes lyophilised RTU qPCR CE/IVD

Intended Use
Vitassay qPCR NG CiproRes allows the identification and qualitative detection of DNA from N. gonorrhoeae and/or a specific point mutation in N. gonorrhoeae (in the gyrA gene, changing the serine in position 91 of the wild type genotype to phenylalanine) that generates resistance to ciprofloxacin (CIP), from urethral urine, urethral swabs, endocervical swabs and rectal swabs samples already characterized as N. gonorrhoeae positive (using molecular assays) of patients suspected of gonorrhea disease. This product is intended to aid in the diagnosis of infections caused by N. gonorrhoeae and its possible resistance or sensitivity to CIP, 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:
- NG CiproRes strips low/high profile: 4x8-well strip containg lyophilised target primer, polymerase (and reverse transciptase) and nucleotides
- NG CiproRes Positive Control (red vial): 1 vial
- 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