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Journal of Clinical Microbiology, January 2004, p. 239-241, Vol. 42, No. 1
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.1.239-241.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Validation of Roche COBAS Amplicor Assay for Detection of Chlamydia trachomatis in Rectal and Pharyngeal Specimens by an omp1 PCR Assay

N. A. Lister, S. N. Tabrizi,* C. K. Fairley, and S. Garland

Department of Public Health, The University of Melbourne, and Department of Microbiology and Infectious Diseases, Royal Women's Hospital, Women's and Children's Health, Melbourne, Australia

Received 3 September 2003/ Returned for modification 14 October 2003/ Accepted 23 October 2003

Screening guidelines for men who have sex with men (MSM) recommend testing of extragenital sites (pharyngeal and rectal) for gonorrhoea and chlamydia. Testing of specimens from these sites is not validated by most commercial nucleic amplification tests, such as the COBAS Amplicor assay. To investigate the utility of the COBAS Amplicor assay for detection of Chlamydia trachomatis in extragenital specimens, this study developed and evaluated confirmatory tests using the omp1 gene as an alternative target for amplification by PCR. Of anal and throat swabs collected from men in male-only saunas, 52 swabs that tested C. trachomatis positive by COBAS Amplicor and 30 swabs that tested as negative were included for confirmatory omp1 PCR testing. A total of 49 (94%) COBAS Amplicor-positive samples were confirmed by the omp1 PCR. A substantial proportion of specimens were confirmed by using a nested omp1 PCR (27%). Not confirmed by any omp1 PCR were three anal swabs (6%). It is most probable that these samples contained lower bacterial levels that were near or below the detection level of the omp1 PCR assays. The findings of this study support the confident reporting of C. trachomatis detected by COBAS Amplicor in extragenital specimens and support the utility of this assay as a screening test for MSM.

* Corresponding author. Mailing address: Department of Molecular Microbiology, The Royal Women's Hospital, 132 Grattan St., Carlton, Melbourne, Victoria 3053, Australia. Phone: (61-3) 9344-2050. Fax: (61-3) 9344-2713. E-mail: Sepehr.Tabrizi{at}wch.org.au.

Journal of Clinical Microbiology, January 2004, p. 239-241, Vol. 42, No. 1
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.1.239-241.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.



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