AdvanDX has received FDA 510(k) clearance for its Yeast Traffic Light PNA Fish to identify Candida yeast species directly from positive blood cultures.
Candidemia, a bloodstream infection caused by Candida species, is one of the most serious hospital acquired infections.
Immunocompromised transplantation, oncology and Aids patients are especially at risk for contracting the infection, with mortality rates as high as 50 per cent.
While identification of the infecting Candida species is used to guide effective antifungal therapy, conventional lab methods can take up to five days or longer.
Laboratories can now identify, in a single Yeast Traffic Light test, up to five Candida species directly from positive blood cultures including C albicans and/or C parapsilosis, C tropicalis, plus C glabrata and/or C krusei.
The identification takes hours instead of days, enabling clinicians to provide early, effective and appropriate antifungal therapy for patients afflicted with candidemia.
