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Journal of Clinical Microbiology, January 2003, p. 304-309, Vol. 41, No. 1
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.1.304-309.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

Performance of the APTIMA Combo 2 Assay for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Female Urine and Endocervical Swab Specimens

C. A. Gaydos,1* T. C. Quinn,1,2 D. Willis,3 A. Weissfeld,4 E. W. Hook,5 D. H. Martin,6 D. V. Ferrero,7 and J. Schachter8

Johns Hopkins University, Baltimore,1 National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland,2 Florida State Department of Health, Jacksonville, Florida,3 Microbiology Specialists Incorporated, Houston, Texas,4 University of Alabama, Birmingham, Alabama,5 Louisiana State University, New Orleans, Louisiana,6 San Joaquin County Public Health Services, Stockton,7 University of California, San Francisco, California8

Received 23 April 2002/ Returned for modification 19 August 2002/ Accepted 15 October 2002

The greater sensitivity of nucleic acid amplification tests (NAATs) for Chlamydia trachomatis and Neisseria gonorrhoeae permits the use of urine and other noninvasive specimens, which can increase the reach and decrease the costs of public health screening programs aimed at controlling these infections. This study evaluated the performance of the APTIMA Combo 2 assay, a multiplex assay based on the transcription-mediated amplification reaction, for the simultaneous detection of both pathogens in endocervical swab and urine specimens from females. Combo 2 assay results were compared with patient infected status, which were available by using other commercial NAATs. Sensitivity and specificity for C. trachomatis were 94.2 and 97.6%, respectively, in swabs and 94.7 and 98.9%, respectively, in first-catch urine (FCU). Sensitivity and specificity for N. gonorrhoeae were 99.2 and 98.7%, respectively, in swabs and 91.3 and 99.3%, respectively, in FCU. The assay reliably detected both infections in coinfected patients. The Combo 2 assay can be recommended for use with endocervical swab and urine specimens from females, especially for screening tests for asymptomatic women in sexually transmitted disease surveillance programs. This Food and Drug Administration-cleared assay can be a useful tool in efforts to reduce the prevalence and incidence of C. trachomatis and N. gonorrhoeae infections in sexually active women and to prevent their costly and serious sequelae.

* Corresponding author. Mailing address: Johns Hopkins University Division of Infectious Diseases, Medicine 1159 Ross Bldg., 720 Rutland Ave., Baltimore, MD 21205. Phone: (410) 614-0932. Fax: (410) 614-9775. E-mail: cgaydos{at}mail.jhmi.edu.

Journal of Clinical Microbiology, January 2003, p. 304-309, Vol. 41, No. 1
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.1.304-309.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.



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