title: Detection of Chlamydia trachomatis in genital specimens by the Chlamydiazyme test.
abstract: Cotton swabs were used to collect two specimens each from 416 patients (206 males, 210 females) attending a sexually transmitted disease clinic. The first swab was transported in Specimen Storage Reagent and extracted in Specimen Dilution Buffer for enzyme immunoassay by Chlamydiazyme (Abbott Laboratories); the second swab was extracted into 2SP and inoculated into McCoy cell cultures. In the first phase of the study (215 patients: 111 males, 114 females) enzyme immunoassay results were positive (optical density greater than or equal to 0.1) in 30 of 35 instances in which Chlamydia 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 three 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.
mesh_terms: D000942:Antigens, Bacterial / Q000032:analysis*; D002478:Cells, Cultured; D002692:Chlamydia trachomatis / Q000276:immunology / Q000302:isolation & purification*; D005069:Evaluation Studies as Topic; D005189:False Positive Reactions; D005260:Female; D005835:Genitalia / Q000382:microbiology*; D006801:Humans; D007124:Immunoenzyme Techniques; D008297:Male; D011933:Reagent Kits, Diagnostic
chemical_list: D000942:Antigens, Bacterial; D011933:Reagent Kits, Diagnostic