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Journal of Clinical Microbiology, March 2001, p. 1008-1016, Vol. 39, No. 3
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.3.1008-1016.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

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

Barbara Van Der Pol,1,* Dennis V. Ferrero,2 Linda Buck-Barrington,2 Edward Hook III,3 Connie Lenderman,3 Thomas Quinn,4 Charlotte A. Gaydos,4 Judith Lovchik,5 Julius Schachter,6 Jeanne Moncada,6 Geraldine Hall,7 Marion J. Tuohy,7 and Robert B. Jones1

Indiana University School of Medicine, Indianapolis, Indiana1; San Joaquin County Public Health Services, Stockton,2 and University of California---San Francisco, San Francisco,6 California; University of Alabama---Birmingham, Birmingham, Alabama3; Johns Hopkins University4 and University of Maryland Medical System,5 Baltimore, Maryland; and Cleveland Clinic Foundation, Cleveland, Ohio7

Received 12 September 2000/Returned for modification 14 November 2000/Accepted 28 December 2000

The performance of the Becton Dickinson BDProbe Tec ET System Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays (BD Biosciences, Sparks, Md.) was evaluated in a multicenter study. Specimens were collected from 2,109 men and women, with or without symptoms, attending sexually transmitted disease, family planning, and obstetrics and gynecology clinics. Both swab and urine samples were collected, and the results obtained from 4,131 specimens were compared to those from culture and the LCx nucleic acid amplification test (Abbott Industries, Abbott Park, Ill.). PCR and cytospin of the culture transport medium with chlamydia direct fluorescent antibody staining were used to adjudicate chlamydia culture-negative results. Sensitivity and specificity were calculated both with and without use of the amplification control (AC), with little apparent difference in the results. Without the AC result, sensitivity for C. trachomatis and N. gonorrhoeae were 92.8 and 96.6%, respectively, for cervical swabs and 80.5 and 84.9% for urine 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 chlamydial and gonococcal infections demonstrated superior sensitivity compared to chlamydia culture and has performance characteristics comparable to those of other commercially available nucleic acid-based assays for these organisms.

* Corresponding author. Mailing address: 545 N. Barnhill #435, Indianapolis, IN 46202. Phone: (317) 274-1422. Fax: (317) 278-1114. E-mail: bvanderp{at}iupui.edu.

Journal of Clinical Microbiology, March 2001, p. 1008-1016, Vol. 39, No. 3
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.3.1008-1016.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.


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