The use of this assay has not been established for screening the general population or for monitoring therapy.
The performance of this assay has not been established for ruling out diseases with similar symptoms eg, diseases caused by Mycobacterium tuberculosis, Coccidioides immitis, Aspergillus fumigatus, Blastomyces dermatitidis, Streptococcus pneumoniae, Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila or other pathogens.
The performance of this assay has not been established for matrices other than serum.
All results from this and other serologies must be correlated with clinical history, epidemiological data, and other data available to the attending physician in evaluating the patient.
The prevalence of infection will affect the assay's predictive value.
The test can be positive with persons that are not currently infected with histoplasma. Antibodies may be present because of a past infection.
The test can be negative with persons that are currently infected with Histoplasma. Samples obtained very early in the infection may not have detectable antibodies.