Results for this test are for research purposes only by the assay’s manufacturer. The performance characteristics of this product have not been established. Results should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure.
A positive test does not necessarily indicate infection since antibodies to Candida species can be detected in uninfected individuals because of their exposure to commensal yeasts. This assay is unable to differentiate antibodies formed during mucosal colonization from those produced during deep infection. Consequentially, antibodies are found in many hospitalized patients who have no obvious Candida infection. A negative result does not rule out the possibility of deep-seated candidiasis in immunocompromised patients.