Comparison of two FDA-cleared EIA assays for the detection of Coccidioides antibodies against a composite clinical standard

Coccidioidomycosis is a disease endemic to the Southwestern United States, parts of Mexico, and Central and South America. Diagnosis of the disease is commonly delayed because of the lack of prompt testing and the dearth of reliable diagnostic tests. Culture and nucleic acid testing require a specimen, yet the typical patient presents with a dry cough and no sputum. Serologic methods depend on an effective antibody response by the patient, but antibody production May be unreliable or delayed until several weeks after initial symptom onset. Most published reports of serologic assays compare them to traditional serologic tests such as complement fixation and immunodiffusion. We sought to characterize the performance of two commercially available serologic tests, Meridian Premier and IMMY Omega, against a composite clinical reference standard to determine the sensitivity and specificity of these tests in detecting whether antibody is likely present in clinical specimens. The composite reference standard included symptoms, radiologic findings, and serologic results from complement fixation and immunodiffusion. For the Meridian test, sensitivity and specificity respectively were 69.4% and 95.4% for immunoglobulin G (Ig G) and 57.1% and 70.4% for immunoglobulin M (IgM). For the IMMY assay, sensitivity and specificity respectively were 53.1% and 96.7% for IgG and 34.7% and 85.5% for IgM.