Associates of Cape Cod, Inc. (ACC), an East Falmouth, Massachusetts-based IVD company, recently launched Fungitell STAT. Fungitell STAT is the first and only single sample format FDA-cleared and CE-marked rapid in vitro diagnostic screening test for invasive fungal infection (IFI) that detects (13)-ß-D-glucan in serum within 60 minutes. This near POC test offers the convenience of either a single patient sample test run or up to seven patient samples per test run providing clinicians with a rapid assessment of patient serum Beta Glucan (BG) levels used as an aid in the early diagnosis of IFI. Using an incubating absorbance tube reader and BG Analytics software, this single sample test allows for the rapid stratification of patients as diagnostically positive, negative or indeterminate relative to serum BG burden.
(13)-ß-D-glucan is produced by common primary human fungal pathogens such as Candida spp., Aspergillus spp. and Pneumocystis spp., as well as many opportunistic fungal pathogens. During infection, (13)-ß-D-glucan produced by certain fungal pathogens may be released into the bloodstream and then detected by the Fungitell STAT assay using patient blood serum. This assay is intended for use as a diagnostic aid in clinical situations where rapid results concerning IFI are required; Fungitell STAT should be used in conjunction with other diagnostic procedures.
Dr. A.J. Meuse, President and Chief Executive Officer of ACC said: “We are pleased to introduce the first and only FDA-cleared and CE-marked single format (13)-ß-DD-glucan assay. ACC believes that Fungitell STAT will offer clinicians the flexibility of decreased turnaround time which is vital for clinical utility in the diagnosis of IFI.”
ACC is one of the world’s largest manufacturers of products developed to detect and quantify Gram-negative bacterial endotoxins and (13)- ß-D-glucans. Their products are used worldwide by leading pharmaceutical and medical device companies to ensure the safety of their parenteral drugs, biological products and medical devices.
For more information, visit: https://www.fungitell.com/fungitell_stat