1 , A. Stroupe 2 , H. Aghazarian 3 , M. Garrett 4 , P. Younse 5 , and M. Powell 6 . 1 Jet Propulsion Laboratory, MS 198-219, 4800 Oak Grove Drive, Pasadena, CA 91109, [email protected]; 2 Jet Propulsion Laboratory, MS 198-219, 4800 Oak Grove Drive, Pasadena, CA 91109, [email protected]; 3 Jet Propulsion Laboratory, MS 198219, 4800 Oak Grove Drive, Pasadena, CA 91109, Hran...

We compared the analytical and clinical performance of cobas® CT/NG for use on the Cobas® 6800/8800 Systems with the Cobas® 4800 CT/NG Test from urogenital and extragenital specimens in over 12,000 specimens from both male and female subjects in Germany and the United States. The analytical sensitivity was ≤40 EB/ml for Chlamydia trachomatis (CT) and ≤1 CFU/ml for Neisseria gonorrhoeae (NG). Us...

This study shows that the clinical performance and reproducibility of the cobas 4800 HPV test for high-risk human papillomavirus (HPV) detection fulfill the criteria as formulated in international guidelines of HPV test requirements for cervical screening purposes. Accordingly, the cobas 4800 HPV test can be considered clinically validated for cervical screening.

In this prospective study, the fully automated cobas 4800 CT/NG and the cobas TaqMan CT tests were compared for Chlamydia trachomatis detection in urine and in genital specimens collected with Copan flocked swabs in culture media. A protocol was also established for the highly sensitive detection of C. trachomatis in semen specimens using the cobas 4800 CT/NG test. A total of 708 consecutive ur...

Clostridium difficile infection is a significant health burden, and innovative solutions are needed to shorten time to diagnosis and improve infection control. We evaluated the performance of the cobas® Cdiff test for use on the cobas® Liat® System (cobas® Liat® Cdiff), a single-sample, on-demand, and automated molecular solution with a 20-min turnaround time. The limit of detection was 45-90 c...

BACKGROUND It is well-known that persistent cervical infections with high-risk human papillomavirus (HPV) are related to the development of high-grade cervical intraepithelial neoplasia and invasive cervical cancer and that infection with HPV 16 and HPV 18 accounts for approximately 70% of all cases of invasive cervical cancer. METHODS We performed 3 HPV molecular tests-the Cobas 4800 HPV tes...