The test has been designed to run either a single patient sample test or up to seven patient samples per test
US-based IVD company Associates of Cape Cod (ACC) has launched Fungitell STAT, its in-vitro diagnostic screening test for invasive fungal infection (IFI)
The test has been designed to run either a single patient sample test or up to seven patient samples per test, to help clinician rapidly assess patient serum Beta Glucan (BG) levels used in the early diagnosis of IFI.
The single sample test utilises an incubating absorbance tube reader and BG Analytics software to rapidly identify diagnostically positive, negative or indeterminate patients, based on serum BG burden.
Fungitell STAT is an FDA approved and CE marked test that detects (1→3)-ß-D-glucan
Fungitell STAT is the first and only single sample format FDA approved and CE marked screening test that detects (1→3)-ß-D-glucan in serum within 60 minutes, said the company.
(1→3)-ß-D-glucan is usually produced by common primary human fungal pathogens including Candida spp., Aspergillus spp. and Pneumocystis spp., along with few other fungal pathogens.
Fungitell STAT assay detects (1→ 3)-ß-D-glucan in the patient blood serum, which was produced by certain fungal pathogens and released into the patient’s bloodstream during their infection.
ACC president and chief executive officer AJ Meuse said: “We are pleased to introduce the first and only FDA-cleared and CE Marked single format (1→ 3)-ß-D-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.”
The company said that its new assay, along with other diagnostic procedures, should be used as a diagnostic aid in clinical situations where rapid results related to IFI are needed.
ACC is a large-scale manufacturer of products developed to detect and quantify Gram-negative bacterial endotoxins and (1→3)-ß-D-glucans.
The company claimed that its products are being used by pharmaceutical and medical device companies around the world, to ensure safety of their parenteral drugs, biological products and medical devices.