Performance of the APTIMA Combo 2 assay for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in female urine and endocervical swab specimens

Charlotte A Gaydos, Thomas C Quinn, D. Willis, A. Weissfeld, E. W. Hook, D. H. Martin, D. V. Ferrero, J. Schachter

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)304-309
Number of pages6
JournalJournal of Clinical Microbiology
Volume41
Issue number1
DOIs
StatePublished - Jan 1 2003
Externally publishedYes

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Neisseria gonorrhoeae
Chlamydia trachomatis
Urine
Nucleic Acid Amplification Techniques
Infection
Sensitivity and Specificity
United States Food and Drug Administration
Sexually Transmitted Diseases
Public Health
Costs and Cost Analysis
Incidence

ASJC Scopus subject areas

  • Microbiology (medical)
  • Microbiology

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Performance of the APTIMA Combo 2 assay for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in female urine and endocervical swab specimens. / Gaydos, Charlotte A; Quinn, Thomas C; Willis, D.; Weissfeld, A.; Hook, E. W.; Martin, D. H.; Ferrero, D. V.; Schachter, J.

In: Journal of Clinical Microbiology, Vol. 41, No. 1, 01.01.2003, p. 304-309.

Research output: Contribution to journalArticle

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