Clinical chemistry substrate IVDs

Intended purpose

The Fungitell assay is a protease zymogen-based colorimetric assay for the qualitative detection of (1-3)-beta-D-glucan in the serum of patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infection. The serum concentration of (1-3)-beta-D-glucan, a major cell-wall component of various medically important fungi, can be used as an aid in the diagnosis of deep-seated mycoses and fungemias. A positive result does not indicate which genus of fungi may be causing infection.