Multicenter evaluation of the BDProbeTec ET system for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in urine specimens, female endocervical swabs, and male urethral swabs

The performance of the Becton Dickinson BDProbe Tec ET System Chlamydia tra chomatis and Neisseria gonorrhoeae Amplified DNA Assays (BD Biosciences, Sp arks, Md.) was evaluated in a multicenter study. Specimens were collected f rom 2,109 men and women, with or without symptoms, attending sexually trans mitted disease, family planning, and obstetrics and gynecology clinics. Bot h swab and urine samples were collected, and the results obtained from 4,13 1 specimens were compared to those from culture and the LCx nucleic acid am plification test (Abbott Industries, Abbott Park, III.), PCR and cytospin o f the culture transport medium with chlamydia direct fluorescent antibody s taining were used to adjudicate chlamydia culture-negative results, Sensiti vity and specificity were calculated both,vith and without use of the ampli fication control (AC), with little apparent difference in the results, With out the AC result, sensitivity for C. trachomatis and N. gonorrhoeae were 9 2.8 and 96.6%, respectively, for cervical swabs and 80.5 and 84.9% for urin e from women, C. trachomatis and N. gonorrhoeae sensitivities were 92.5 and 98.5%, respectively, for male urethral swabs and 93.1 and 97.9% for urine from men. This amplified DNA system for simultaneous detection of chlamydia l and gonococcal infections demonstrated superior sensitivity compared to c hlamydia culture and has performance characteristics comparable to those of other commercially available nucleic acid-based assays for these organisms .