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Journal of Clinical Microbiology, October 2000, p. 3544-3549, Vol. 38, No. 10
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.

Multicenter Evaluation of AMPLICOR and Automated COBAS AMPLICOR CT/NG Tests for Neisseria gonorrhoeae

David H. Martin,1,2,* Cathy Cammarata,1,2 Barbara Van Der Pol,3 Robert B. Jones,3 Thomas C. Quinn,4,5 Charlotte A. Gaydos,5 Kimberly Crotchfelt,5 Julius Schachter,6 Jeanne Moncada,6 D. Jungkind,7 Buffy Turner,8 and Cynthia Peyton8

Louisiana State University1 and City of New Orleans' Delgado Clinic,2 New Orleans, Louisiana; Indiana University School of Medicine, Indianapolis, Indiana3; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland4; Johns Hopkins University, Baltimore, Maryland5; University of California---San Francisco, San Francisco, California6; Thomas Jefferson University Hospital, Pittsburgh, Pennsylvania7; and University of Texas Medical Branch, Galveston, Texas8

Received 3 March 2000/Returned for modification 20 May 2000/Accepted 15 July 2000

The fully automated COBAS AMPLICOR CT/NG and semiautomated AMPLICOR CT/NG tests were evaluated in a multicenter trial for their ability to detect Neisseria gonorrhoeae infections. Test performance compared to that of culturing was evaluated for 2,192 matched endocervical swab and urine specimens obtained from women and for 1,981 matched urethral swab and urine specimens obtained from men. Culture-negative, PCR-positive specimens that tested positive in a confirmatory PCR test for an alternative target sequence within the N. gonorrhoeae 16S rRNA gene were considered to be true positives. The overall prevalences of gonorrhea were 6.6% in women and 20.1% in men. The COBAS AMPLICOR and AMPLICOR formats yielded concordant results for 98.8% of the specimens and exhibited virtually identical sensitivities and specificities. The results that follow are for the COBAS AMPLICOR format. With the infected patient as the reference standard, the resolved sensitivities of PCR were 92.4% for endocervical swab specimens and 64.8% for female urine specimens. There were no significant differences in these rates between women with and without symptoms. Among symptomatic men, COBAS AMPLICOR sensitivities were 94.1% for urine and 98.1% for urethral swabs; for asymptomatic men, the results were 42.3 and 73.1%, respectively. In comparison, the sensitivities of culturing were 84.8% for endocervical specimens, 92.7% for symptomatic male urethral specimens, and only 46.2% for urethral specimens obtained from asymptomatic men. When PCR results were analyzed as if only a single test had been performed on a single specimen type, the resolved sensitivity was always higher. The resolved specificities of PCR were 99.5% for endocervical swab specimens, 99.8% for female urine specimens, 98.9% for male urethral swab specimens, and 99.9% for male urine specimens. The internal control revealed that 2.1% of specimens were inhibitory when initially tested. Nevertheless, valid results were obtained for 99.2% of specimens because 60.0% of the inhibitory specimens were not inhibitory when a second aliquot was tested. The COBAS AMPLICOR CT/NG test for N. gonorrhoeae exhibited high sensitivity and specificity with urethral swab and urine specimens from men and endocervical swab specimens from women and thus is well suited for diagnosing and screening for N. gonorrhoeae infection.

* Corresponding author. Mailing address: Department of Internal Medicine, LSU Medical Center, 1542 Tulane Ave., New Orleans, LA 70118. Phone: (504) 568-5031. Fax: (504) 568-6752. E-mail: dhmartin{at}lsumc.edu.

Journal of Clinical Microbiology, October 2000, p. 3544-3549, Vol. 38, No. 10
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.


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