Performance characteristics of the Cobas 4800 CT/NG assay were estimated for vaginal swab samples from more than 4000 women. Vaginal samples identified 92.9% and 98.5% of Chlamydia and Gonorrhea infections, respectively, which was more than any other single specimen type (endocervical swabs or urine) regardless of collection method (clinician collected or self-obtained).
The excellent performance characteristics of the Cobas 4800 C/NG assay using vaginal samples is consistent with the Centers for Disease Control and Prevention recommendation that vaginal swabs be used for routine sexually transmitted infection screening.
From the *Indiana University School of Public Health, Bloomington †Indiana University School of Medicine, Indianapolis, IN; ‡Louisiana State University Health Sciences Center, New Orleans, LA; §Medical and Scientific Affairs, Roche Molecular Systems, Pleasanton, CA ¶University of Alabama at Birmingham, and ∥Jefferson County Health Department, Birmingham, AL
We are grateful to John Duncan for expert statistical support and to the members of the collection and testing sites.
B.V.D.P. has consulted for honorarium for Roche. Roche has also supported B.D.V.P. for travel to meetings for the study or other purposes. B.D.V.P. has also consulted for BD Diagnostics. O.L. is currently employed by Roche Molecular Systems as the Director of Medical and Scientific Affairs. As an employee of Roche Molecular Systems, O.L. also owns stocks of Roche. E.W.H. has consulted for Cempra Pharmaceuticals. He has also been employed by MedHelp.org in the role of providing answers to online questions from persons with and at risk for sexually transmitted disease. E.W.H. has also received royalties from McGraw Hill for his work as a book editor and has received payment for the development of educational presentations on Herpes Testing for BD. S.N.T. and J.A.W. have no conflict of interests.
Correspondence: Barbara Van Der Pol, PhD, MPH, Department of Epidemiology and Biostatistics, Indiana University School of Public Health, 1025 E Seventh St, Suite 112, Bloomington, IN 47405. E-mail: firstname.lastname@example.org.
Received for publication June 5, 2012, and accepted August 28, 2012.