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Journal of Clinical Microbiology, August 2001, p. 2928-2932, Vol. 39, No. 8
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.8.2928-2932.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

Evaluation of COBAS AMPLICOR (Roche): Accuracy in Detection of Chlamydia trachomatis and Neisseria gonorrhoeae by Coamplification of Endocervical Specimens

Charles H. Livengood III* and Jane W. Wrenn

Chlamydia Laboratory, Duke University Medical Center, Durham, North Carolina

Received 18 January 2001/Returned for modification 8 March 2001/Accepted 2 May 2001

We evaluated further the accuracy of the COBAS AMPLICOR (Roche) (CA) PCR-based system in detection of Chlamydia trachomatis and Neisseria gonorrhoeae in endocervical specimens. Endocervical specimens collected for any indication for testing for C. trachomatis and N. gonorrhoeae among a university hospital health system population were included. Testing for C. trachomatis was done by two PCR methods, CA and manual microwell AMPLICOR (Roche) (MWA), and by culture; testing for N. gonorrhoeae was done by CA and culture. Discrepancy resolution was performed. Reproducibility testing and hands-on labor time measurements for CA were done. Among 654 C. trachomatis samples, the prevalence of true positivity was 9.2%, and among the 618 N. gonorrhoeae samples, the prevalence of true positivity was 4.4%. For detection of C. trachomatis, the sensitivity, specificity, and negative and positive predictive values were, respectively, as follows for each test: CA, 93.3, 99.7, 99.3, and 96.4%; MWA, 91.7, 99.7, 99.2, and 96.5%; and culture, 65.0, 100, 96.6, and 100%. For detection of N. gonorrhoeae those values were as follows: CA, 96.3, 100, 99.8, and 100%; and culture, 92.6, 100, 99.7, and 100%. Hands-on labor time for each clinical result was estimated to be at 7.5 min. The prevalence of inhibitory specimens was 3.5%, including two positive C. trachomatis samples which would have been missed otherwise. The direct cost of each clinical result with CA was estimated to be $9.09. Our methods include a diverse range of indications for testing among women, using endocervical swabbing samples, 2 M sucrose phosphate transport medium, and discrepancy resolution for comparison. Under our test conditions, the CA system is an accurate, rapid, and cost- and labor-efficient method for detection of C. trachomatis and N. gonorrhoeae.

* Corresponding author. Mailing address: Box 3291, Duke Hospital, Durham, NC 27710. Phone: (919) 684-4647. Fax: (919) 681-5929. E-mail: liven001{at}mc.duke.edu.

Journal of Clinical Microbiology, August 2001, p. 2928-2932, Vol. 39, No. 8
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.8.2928-2932.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.


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