Vaginosis (Candida albicans, Gardnerella vaginalis and Trichomonas vaginalis) lyphilized RTU qPCR CE/IVD

Intended Use:
Vitassay qPCR Vaginosis allows the detection and differentiation of Candida albicans, Gardnerella vaginalis and Trichomonas vaginalis by real-time PCR in clinical samples. The product is intended for use in the diagnosis of Candida albicans, Gardnerella vaginalis and Trichomonas vaginalis infections alongside clinical data of the patient 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:
- Vaginosis strips low/high profile
- Vaginosis 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: 4x8 cap strip
- For quantitative assay: target specific standard

Kit Format:
qualitative