Detection of Chlamydia trachomatis in genital specimens by the Chlamydiazyme test

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Abstract
Cotton swabs were used to collect 2 specimens each from 416 patients (206 males, 210 females) attending a sexually transmitted disease clinic. The 1st swab was transported in Specimen Storage Reagent and extracted in Specimen Dilution Buffer for enzyme immunoassay by Chlamydiazyme; the 2nd swab was extracted into 2SP and inoculated into McCoy cell cultures. In the 1st phase of the study (215 patients: 111 males, 114 females) enzyme immunoassay results were positive (optical density .gtoreq. 0.1) in 30 of 35 instances in which C. trachomatis was isolated (sensitivity, 86%). Of 18 false-positive enzyme immunoassay results, 15 (83%) were cervical swabs (specificity, 90%). In a phase II study, using a modified Chlamydiazyme kit, 201 patients were tested (95 males, 106 females). Of 41 chlamydial isolates, 8 were not detected by the Chlamydiazyme test (sensitivity, 81%). Only 3 positive Chlamydiazyme test results could not be confirmed by culture (specificity, 98%). Overall, Chlamydiazyme assay provided a rapid (4 h), sensitive and specific assay for the detection of chlamydial antigens.