Effect of endocervical specimen quality on detection of Chlamydia trachomatis and on the incidence of false-positive results with the Chlamydiazyme method

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Abstract
Duplicate endocervical swabs were collected from 1,675 patients to assess the effects of variations in specimen quality on Chlamydiazyme (Abbott Laboratories) detection of Chlamydia trachomatis and the incidence of false-positive results. One swab (at random) from each patient was tested for C. trachomatis antigen by using the standard Chlamydiazyme procedure. A 200-.mu.l volume of 0.9% saline was added to the other swab from each patient. After vortexing, 20 .mu.l was smeared on a slide for Papanicolaou (Pap) staining and the remaining specimen was then tested with the Chlmydiazyme assay. The Chlamydiazyme result was positive for 170 (10.1%) and 165 (9.8%) of the stained and unstained duplicate specimens, respectively (no significant difference). Pap stains on smears from 1,536 (91.7%) of the patients were analyzed, and endocervical and/or metaplastic (E-M) cells were detected in 789 (51.4%) smears. Of these 1,536 stained and analyzed specimens, 150 (9.8%) were Chlamydiazyme positive but only 132 (88.0%) of the positive results were confirmed by repeating the test and using a monoclonal blocking antibody (Abbott). Confirmed Chlamydiazyme-positive results were obtained from only 34 (4.6%) of 747 specimens lacking E-M cells but from 98 (12.4%) of 789 specimens containing the cells (P < 0.001). Of the 150 initially Chlamydiazyme-positive results obtained with Pap-stained, analyzed specimens, 12 (26.1%) of 46 were falsely positive from specimens lacking E-M cells but only 6 (5.8%) of 104 were falsely positive from specimens containing E-M cells (P < 0.01). C. trachomatis antigen was detected significantly more frequently and false-positive results were significantly less common from specimens in which E-M cells were detected.