Performance of cobas® 4800 and m2000 real-time™ assays for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in rectal and self-collected vaginal specimen

Tanja H Geelen; John W Rossen; Antoine M Beerens; Linda Poort; Servaas A Morré; Wilma S Ritmeester; Harry E van Kruchten; Masja M van de Pas; Paul H M Savelkoul

doi:10.1016/j.diagmicrobio.2013.06.020

Performance of cobas® 4800 and m2000 real-time™ assays for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in rectal and self-collected vaginal specimen

Diagn Microbiol Infect Dis. 2013 Oct;77(2):101-5. doi: 10.1016/j.diagmicrobio.2013.06.020. Epub 2013 Jul 23.

Authors

Tanja H Geelen¹, John W Rossen, Antoine M Beerens, Linda Poort, Servaas A Morré, Wilma S Ritmeester, Harry E van Kruchten, Masja M van de Pas, Paul H M Savelkoul

Affiliation

¹ Department of Medical Microbiology, University Medical Center Maastricht, The Netherlands.

PMID: 23891224
DOI: 10.1016/j.diagmicrobio.2013.06.020

Abstract

A prospective, multicenter trial was designed to compare the performance characteristics of the cobas® 4800 (Roche Diagnostics, Indianapolis, IN, USA) and m2000 real-time™ (Abbott Molecular Inc., Des Plaines, IL, USA) assays for detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in rectal and self-collected vaginal swabs. Rectal (n = 234) or self-collected vaginal swabs (n = 687) were obtained from consenting individuals visiting their general practitioners, dermatologists, gynecologists, sexually transmitted disease clinics, or family planning centers from May 2010 to February 2011. High concordance rates (≥96%) were observed between the cobas® 4800 and m2000 real-time™ assays for CT/NG detection in both rectal and self-collected vaginal swabs. The performance profiles confirm the usefulness of both kinds of swab types for CT and NG detection using described nucleic acid amplification tests assays. Based on this study, rectal and self-collected vaginal swabs offer a noninvasive alternative, which may improve screening for CT and NG infections.

Keywords: Chlamydia trachomatis; Diagnostic screening; Neisseria gonorrhoeae; PCR; Rectal swabs; Self-collected vaginal swabs; Sexually transmitted infections.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Bacterial Typing Techniques / methods*
Chlamydia Infections / diagnosis
Chlamydia Infections / microbiology*
Chlamydia trachomatis / genetics
Chlamydia trachomatis / isolation & purification*
DNA, Bacterial / isolation & purification
Female
Gonorrhea / diagnosis
Gonorrhea / microbiology*
Humans
Male
Neisseria gonorrhoeae / genetics
Neisseria gonorrhoeae / isolation & purification*
Polymerase Chain Reaction / methods
Prospective Studies
Rectum / microbiology*
Reproducibility of Results
Sensitivity and Specificity
Specimen Handling / methods
Vagina / microbiology*

Substances

DNA, Bacterial