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The Fungitell® STAT assay is a protease zymogen-based colorimetric assay for the qualitative detection of (1->3)-B-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)-B-glucan, a major cell-wall component of various medically important fungis, 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. (1->3)-B-D-glucan index values should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.

The Fungitell® STAT assay provides a qualitative measurement of (1-3)-D-Dglucan. The assay is based upon a modification of the Limulus Amebocyte Lysate (LAL) pathway. The Fungitell® STAT Reagent is modified to eliminate bacterial endotoxin reactivity and, thus, to only react to (1->3)-B-glucan, through the Factor Gmediated side of the pathway. (1->3)-3-D-glucan activates Factor G, a serine protease zymogen. The activated Factor G converts the inactive pro-clotting enzyme to the active clotting enzyme, which in turn cleaves the para-nitroanilide substrate, Boc-Leu-Gly-Arg-pNA, creating a chromophore, para-nitroaniline (pNA), that absorbs at 405 nm. The Fungitell® STAT kinetic assay is based upon the determination of the rate of optical density increase produced by a sample. This rate is interpreted against the rate of optical density increase of the Fungitell® STAT Standard to produce an index. This patient sample index value is qualitatively interpreted as a Negative, Indeterminate or Positive result according to the index value ranges provided in Table 1 below. The Fungitell® STAT Standard is calibrated at 80 +/- 8 pg/mL which is the Positive cut-off for the Fungitell® predicate.