Evaluation of Pharmacia Chlamydia EIA for diagnosis of genital infections caused by Chlamydia trachomatis.

A new enzyme-immunoassay test (EIA), Pharmacia Chlamydia EIA, was evaluated in comparison with isolation in cell culture for the diagnosis of genital infections caused by Chlamydia trachomatis. Endocervical and endourethral specimens were collected from 913 patients (875 female and 38 male patients respectively). Sensitivity, specificity, positive predictive and negative predictive values for this test were 89.4%, 99.2%, 85.8% and 99.4% respectively. Where discrepancies between the 2 techniques occurred, the remainder of the EIA buffer was stained for chlamydial antigen by direct immunofluorescence using the Syva Microtrak Chlamydia trachomatis Direct Specimen Test. Laboratory strains of various micro-organisms that may be present in genital specimens did not cross react with the EIA test except for Staphylococcus aureus and Group B Streptococcus at very high concentrations. The Pharmacia Chlamydia EIA is suitable for a laboratory which handles a large number of chlamydial specimens daily. However, when interpreting EIA results, the prevalence of chlamydial infection in the patient population should be established. At present, EIA tests are unsuitable as the only test for chlamydial diagnosis in low risk populations.