Interpretation

The Fungitell assay should be used in conjunction with other diagnostic procedures, such as routine bacterial/fungal cultures, histologic examination of biopsy material, and radiologic studies.

Positive:

(1,3)-Beta-D-glucan detected. A single positive result should be interpreted with caution and correlated alongside consideration of patient risk for invasive fungal disease, results of routine laboratory tests (eg, bacterial and fungal culture, histopathologic evaluation), and radiologic findings. Repeat testing on a new sample (collected in 3-4 days) is recommended as serially positive samples are associated with a higher diagnostic odds ratio for invasive fungal infection compared to a single positive result.

False-positive results may occur in patients who have recently (in the past 3-4 days) undergone hemodialysis, treatment with certain fractionated blood products (eg, serum albumin, immunoglobulins), or those who have had significant exposure to glucan-containing gauze during surgery.

Indeterminate:

Repeat testing on a new sample is recommended in patients at risk for an invasive fungal infection.

Negative:

No (1,3)-Beta-D-glucan detected.

This assay does not detect certain fungi, including Cryptococcus species, which produce very low levels of (1,3)-beta-D-glucan (BDG) and the Mucorales (eg, Lichtheimia, Mucor, and Rhizopus), which are not known to produce BDG. Additionally, the yeast phase of Blastomyces dermatitidis produces little BDG and may not be detected by this assay.