EVALUATION OF SANOFI DIAGNOSTICS PASTEUR CHLAMYDIA MICROPLATE EIA SHORTENED ASSAY AND COMPARISON WITH CELL-CULTURE AND SYVA CHLAMYDIA MICROTRAK-II EIA IN HIGH-RISK AND LOW-RISK POPULATIONS

Seven hundred thirty-two female urogenital samples were collected for Chlamydia trachomatis testing by both the Sanofi Diagnostics Pasteur ( Chaska, Minn.) Chlamydia Microplate EIA by the shortened protocol and the Syva (San Jose, Calif.) MicroTrak II EIA, and the results were com pared with those obtained by cell culture. For the analysis of samples from female patients, the patients were divided into high- and low-ri sk categories. An additional 121 male urethral samples were collected and tested by the Sanofi Microplate EIA and cell culture; for the anal ysis of samples from male patients, the patients were divided into asy mptomatic and symptomatic categories. All specimens positive by enzyme immunoassay (EIA) were confirmed by a blocking assay following the re spective manufacturer's instructions. Specimens negative by EIA that f ell within a gray zone 30% below the cutoff and negative cultures with one or more corresponding positive EIA results were tested further by cytocentrifugation and direct immunofluorescent assay. The overall se nsitivity, specificity, positive predictive value, and negative predic tive value for Syva versus culture were 94, 98.8, 85.5 and 99.6%, resp ectively. After resolution, the results were 94.5, 99.6, 94.5, and 99. 6%, respectively. The parallel results for the Sanofi Microplate ELA v ersus culture were 94.0, 98.7, 83.9, and 99.6%, respectively, and afte r being resolved, the results were 94.9, 100, 100, and 99.6%, respecti vely. In the small male population tested, the resolved results of the Sanofi Microplate EIA versus culture demonstrated sensitivity, specif icity, positive predictive value, and negative predictive value of 100 , 100, 100, and 100%, respectively, The present study demonstrated tha t the Sanofi Microplate EIA shortened protocol is highly sensitive and specific in comparison ,vith cell culture and the Syva MicroTrak II E IA.