Specimen

Serum

Collection Medium:

Minimum:

Preferred adult minimum:  1.0 mls serum
Absolute adult minimum:   0.5 mls serum

Rejection Criteria:

Hemolyzed, lipemic, or icteric specimens.

Analytic Time:

5 working days

Reference Range:

Reference Values
Negative:       Less than 60 pg/mL
Indeterminate:  60 - 79 pg/mL
Positive:       Greater than or equal to 80 pg/mL

The Fungitell assay is indicated for presumptive diagnosis of fungal 
infection. It should be used in conjunction with other diagnostic 
procedures. The Fungitell assay does not detect certain fungal species 
such as the genus Cryptococcus, which produces very low levels of 
(1->3)-Beta-D-glucan . This assay also does not detect the Zygomycetes, 
such as Absidia, Mucor, and Rhizopus, which are not known to produce 
(1->3)-Beta-D-glucan.

Comments:

Clinical Significance
Normal human serum contains low levels of (1->3)-Beta-D-glucan, 
typically 10-40 pg/mL, presumably from commensal yeasts present in the 
alimentary canal and gastrointestinal tract. Most pathogenic fungi have 
(1->3)-Beta-D-glucan in their cell walls and minute quantities are 
sloughed into the circulation during the life cycle. Thus, 
(1->3)-Beta-D-glucan appears in the serum in cases of invasive fungal 
infection (IFI). Monitoring serum (1->3)-Beta-D-glucan for evidence of 
elevated and rising levels provides a convenient surrogate marker for 
IFI. Levels above 80 pg/mL, in at-risk patients, are considered 
positive. Because a fungal infection is a dynamic process, repeat 
testing, typically 2-3 times per week, improves sensitivity. Time 
courses of serum (1->3)-Beta-D-glucan levels through the course of an 
infection have been shown to exhibit a rising level which falls in 
response to efficacious therapy.  [Kondori N., Edebo L., and 
Mattsby-Baltzer I.  Circulating (1->3)-Beta-D-glucan and Immunoglobulin 
G subclass antibodies to antibodies to candia albicans cell wall 
antigens in patients with systemic candidiasis. Clinical and diagnostic 
Laboratory Immunology. 11(2):344-350 (2004)

The Fungitell assay is indicated for presumptive diagnosis of fungal 
infection. It should be used in conjunction with other diagnostic 
procedures. The Fungitell assay does not detect certain fungal species 
such as the genus Cryptococcus, which produces very low levels of 
(1->3)-Beta-D-glucan . This assay also does not detect the Zygomycetes, 
such as Absidia, Mucor, and Rhizopus, which are not known to produce 
(1->3)-Beta-D-glucan.

Methodology:

Infectious agent antigen detection by enzyme immunoassay technique

CPT Code:

87449