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Evaluation of COBAS AMPLICOR (Roche): accuracy in detection of Chlamydia trachomatis and Neisseria gonorrhoeae by coamplification of endocervical specimens.
J Clin Microbiol. 2001 Aug; 39(8):2928-32.JC

Abstract

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.

Authors+Show Affiliations

Chlamydia Laboratory, Duke University Medical Center, Durham, North Carolina, USA. liven001@mc.duke.eduNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11474015

Citation

Livengood, C H., and J W. Wrenn. "Evaluation of COBAS AMPLICOR (Roche): Accuracy in Detection of Chlamydia Trachomatis and Neisseria Gonorrhoeae By Coamplification of Endocervical Specimens." Journal of Clinical Microbiology, vol. 39, no. 8, 2001, pp. 2928-32.
Livengood CH, Wrenn JW. Evaluation of COBAS AMPLICOR (Roche): accuracy in detection of Chlamydia trachomatis and Neisseria gonorrhoeae by coamplification of endocervical specimens. J Clin Microbiol. 2001;39(8):2928-32.
Livengood, C. H., & Wrenn, J. W. (2001). Evaluation of COBAS AMPLICOR (Roche): accuracy in detection of Chlamydia trachomatis and Neisseria gonorrhoeae by coamplification of endocervical specimens. Journal of Clinical Microbiology, 39(8), 2928-32.
Livengood CH, Wrenn JW. Evaluation of COBAS AMPLICOR (Roche): Accuracy in Detection of Chlamydia Trachomatis and Neisseria Gonorrhoeae By Coamplification of Endocervical Specimens. J Clin Microbiol. 2001;39(8):2928-32. PubMed PMID: 11474015.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of COBAS AMPLICOR (Roche): accuracy in detection of Chlamydia trachomatis and Neisseria gonorrhoeae by coamplification of endocervical specimens. AU - Livengood,C H,3rd AU - Wrenn,J W, PY - 2001/7/28/pubmed PY - 2002/1/5/medline PY - 2001/7/28/entrez SP - 2928 EP - 32 JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 39 IS - 8 N2 - 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. SN - 0095-1137 UR - https://www.unboundmedicine.com/medline/citation/11474015/Evaluation_of_COBAS_AMPLICOR__Roche_:_accuracy_in_detection_of_Chlamydia_trachomatis_and_Neisseria_gonorrhoeae_by_coamplification_of_endocervical_specimens_ L2 - http://jcm.asm.org/cgi/pmidlookup?view=long&pmid=11474015 DB - PRIME DP - Unbound Medicine ER -