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Journal of Clinical Microbiology, March 2000, p. 1105-1112, Vol. 38, No. 3
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.

Multicenter Evaluation of the AMPLICOR and Automated COBAS AMPLICOR CT/NG Tests for Detection of Chlamydia trachomatis

Barbara Van Der Pol,1,* Thomas C. Quinn,2,3 Charlotte A. Gaydos,3 Kimberly Crotchfelt,3 Julius Schachter,4 Jeanne Moncada,4 D. Jungkind,5 David H. Martin,6,7 Buffy Turner,8 Cynthia Peyton,8 and Robert B. Jones1

Indiana University School of Medicine, Indianapolis, Indiana1; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda,2 and Johns Hopkins University, Baltimore,3 Maryland; University of California-San Francisco, San Francisco, California4; Thomas Jefferson University Hospital, Pittsburgh, Pennsylvania5; Louisiana State University,6 and City of New Orleans' Delgado Clinic,7 New Orleans, Louisiana; and University of Texas Medical Branch, Galveston, Texas8

Received 27 September 1999/Returned for modification 22 November 1999/Accepted 24 December 1999

The fully automated COBAS AMPLICOR CT/NG and semiautomated AMPLICOR CT/NG tests were evaluated in a multicenter trial for the ability to detect Chlamydia trachomatis infections. Test performance compared to that of culture was evaluated for 2,236 matched endocervical swab and urine specimens obtained from women and for 1,940 matched urethral swab and urine specimens obtained from men. Culture-negative, PCR-positive specimens that tested positive in a direct fluorescent-antibody test or in a confirmatory PCR test for an alternative target sequence were resolved as true positives. The overall prevalences of chlamydia were 2.4% in women and 7.2% in men. The COBAS AMPLICOR and AMPLICOR formats yielded concordant results for 98.1% of the specimens. With the infected patient as the reference standard, the resolved sensitivities of COBAS AMPLICOR were 89.7% for endocervical swab specimens, 89.2% for female urine specimens, 88.6% for male urethral swab specimens, and 90.3% for male urine specimens. When 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 99.4% for endocervical swab specimens, 99.0% for female urine specimens, 98.7% for male urethral swab specimens, and 98.4% for male urine specimens. The internal control revealed that 2.4% of the specimens were inhibitory when initially tested. Nevertheless, valid results were obtained for 98.6% of the specimens because 59.1% of the inhibitory specimens were not inhibitory when a second aliquot was tested. The COBAS AMPLICOR and AMPLICOR CT/NG tests for C. trachomatis exhibited equally high sensitivity and specificity with both urogenital swab and urine specimens and thus are well suited for screening for C. trachomatis infection.

* 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 2000, p. 1105-1112, Vol. 38, No. 3
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.


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