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

doi:10.1128/JCM.39.3.1008-1016.2001

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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 DNAAssays (BD Biosciences, Sparks, Md.) was evaluated in a multicenterstudy. Specimens were collected from 2,109 men and women, withor without symptoms, attending sexually transmitted disease, familyplanning, and obstetrics and gynecology clinics. Both swab andurine samples were collected, and the results obtained from 4,131specimens were compared to those from culture and the LCx nucleicacid amplification test (Abbott Industries, Abbott Park, Ill.).PCR and cytospin of the culture transport medium with chlamydiadirect fluorescent antibody staining were used to adjudicate chlamydiaculture-negative results. Sensitivity and specificity were calculatedboth with and without use of the amplification control (AC), withlittle apparent difference in the results. Without the AC result,sensitivity for C. trachomatis and N. gonorrhoeae were 92.8 and96.6%, respectively, for cervical swabs and 80.5 and 84.9% forurine from women. C. trachomatis and N. gonorrhoeae sensitivitieswere 92.5 and 98.5%, respectively, for male urethral swabs and93.1 and 97.9% for urine from men. This amplified DNA system forsimultaneous detection of chlamydial and gonococcal infectionsdemonstrated superior sensitivity compared to chlamydia cultureand has performance characteristics comparable to those of othercommercially available nucleic acid-based assays for theseorganisms.

^* 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.

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