MycoReal Kit Candida & A. fumigatus (Module 7-8)

Detection of ITS2-region of Candida and Aspergillus fumigatus.

Background: Candidiasis is a yeast infection caused by different Candida species. Candida can cause opportunistic infections of the skin and mucosa as well as invasive infections. Aspergilli are ubiquitous molds that can cause allergies as well as infections (aspergilloses). Invasive candidiasis and aspergillosis are increasingly recognized as a primary cause of morbidity and mortality especially in immunocompromised patients, patients with severe underlying disorders or intensive care patients. The pathogen can be detected in biopsies from the affected organ or in the blood. The rapid and early diagnosis of a fungal infection is of particular importance with regard to survival and cure rates. Not only the detection, but also the exact identification of the fungal species is important.

Description: MycoReal Kit Candida & A. fumigatus is an in vitro diagnostic test based on real-time PCR, for the qualitative detection of specific DNA of C. albicans, C. dubliniensis, C. glabrata, C. krusei (= Pichia kudriavzevii, Issatchenkia orientalis), C. parapsilosis group, C. tropicalis and Aspergillus fumigatus. Starting material is DNA purified from blood, biopsies, aspirates, punctates, cerebrospinal fluid (CSF) or samples of the respiratory tract. The kit supports the detection of a Candida or A. fumigatus infection of patients with a suspected sepsis or fungal infection. The species are detected with two different assay mixes (Module 7 and Module 8) which must be analyzed in parallel. With this approach, C. glabrata, C. krusei, C. parapsilosis and A. fumigatus can be differentiated from other Candida species, which enables specific antifungal therapy. Since MycoReal Kits and PanReal Kit use identical temperature/time profiles, they can be combined in the same real-time PCR run. This allows the detection of a wide panel of pathogenic fungi within only a few hours.

Product Features:
- Amplification and detection: ITS2-Region of Candida and A. fumigatus
- CE-IVD Real-time PCR with rapid hot-start Taq DNA polymerase
- ROX™ dye as passive reference
- Internal Positive Control System to exclude false-negative results
- Optimized to handle PCR inhibitors
- PCR- platforms: runs on all established standard real-time PCR- platforms
- Harmonized thermal profiles to run RNA and DNA samples simultaneously
- Declaration of Conformity