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      High-Throughput Testing of Urogenital and Extragenital Specimens for Detection of Chlamydia Trachomatis and Neisseria Gonorrhoeae with Cobas ® CT/NG

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          Abstract

          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). Using clinical specimens, the overall percent agreement with the Cobas ® 4800 CT/NG Test was >98.5%. Across urogenital specimens, there were 93 discrepant specimens; 76 (93.8%) of 81 CT discrepant specimens were 6800+/4800– and 10 (83.3%) of 12 NG discrepant specimens were 6800+/4800–. Sequencing verified CT results for 45 (61.6%) of 73 samples positive by 6800 and 1 (20%) of 5 positive by 4800. Similarly, 7 (70.0%) of 10 NG samples positive by 6800 and 1 of 2 positive by 4800 were confirmed by sequencing. Among discrepant extragenital specimens (all 6800+/4800–), 7 (50%) of 14 oropharyngeal and 23 (76.7%) of 30 anorectal CT discordant samples were confirmed as CT positive by sequencing; all 8 anorectal and 20 (90.9%) of 22 oropharyngeal NG discordant results were also confirmed as NG positive. In conclusion, Cobas ® CT/NG for use on the Cobas ® 6800/8800 Systems provides high-throughput automated solutions for sexually transmitted infection (STI) screening programs.

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          Prevalence of rectal, urethral, and pharyngeal chlamydia and gonorrhea detected in 2 clinical settings among men who have sex with men: San Francisco, California, 2003.

          Charlotte Kent, Janice K Chaw, William WY Wong … (2005)
          The Centers for Disease Control and Prevention developed screening and diagnostic testing guidelines for chlamydia and gonorrhea at urethral, rectal, and pharyngeal sites for men who have sex with men (MSM). However, in most clinical settings, rectal chlamydial testing is not performed for MSM, and primarily sexually transmitted disease (STD) clinics alone perform routine rectal and pharyngeal gonorrhea screening for asymptomatic men. We evaluated the prevalence of rectal, urethral, and pharyngeal chlamydial and gonococcal infections among MSM seen at the municipal STD clinic and the gay men's community health center. We also determined the proportion of asymptomatic rectal infections, described the patterns of single and multiple anatomic sites of infection, and evaluated the proportion of chlamydial infections that would be missed and not treated if MSM were not routinely tested for chlamydia. We tested specimens using previously validated nucleic acid amplification tests (NAATs). The prevalence of infection varied by anatomic site (chlamydia: rectal, 7.9%; urethral, 5.2%; and pharyngeal, 1.4%; for gonorrhea, rectal, 6.9%; urethral, 6.0%; and pharyngeal, 9.2%). Approximately 85% of rectal infections were asymptomatic supporting the need for routine screening. Because 53% of chlamydial infections and 64% of gonococcal infections were at nonurethral sites, these infections would be missed and not treated if only urethral screening was performed. In addition, >70% of chlamydial infections would be missed and not treated if MSM were tested only for gonorrhea. Because these infections enhance both HIV transmission and susceptibility, clinical settings serving MSM should evaluate the prevalence of chlamydial and gonococcal infections by anatomic site using validated NAATs.
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            Incidence of Gonorrhea and Chlamydia Following HIV Preexposure Prophylaxis among Men Who Have Sex with Men: A Modeling Study.

            Samuel Jenness, Kevin Weiss, Steven Goodreau … (2017)
            Preexposure prophylaxis (PrEP) is highly effective for preventing HIV, but risk compensation (RC) in men who have sex with men (MSM) raises concerns about increased sexually transmitted infections (STIs). CDC's PrEP guidelines recommend biannual STI screening, which may reduce incidence by treating STIs that would otherwise remain undiagnosed. We investigated the impact of these two potentially counteracting phenomena.
            Article 0 comments Cited 82 times – based on 0 reviews     Review now
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              The incidence and correlates of symptomatic and asymptomatic Chlamydia trachomatis and Neisseria gonorrhoeae infections in selected populations in five countries.

              Roger Detels, Annette M Green, Jeffrey D Klausner … (2011)
              Asymptomatic Chlamydia trachomatis (chlamydia) and Neisseria gonorrhoeae (gonorrhea) infections pose diagnostic and control problems in developing countries. Participants in China, India, Peru, Russia, and Zimbabwe were screened for C. trachomatis and N. gonorrhoeae infections and symptoms. A total of 18,014 participants were evaluated at baseline, 15,054 at 12 months, and 14,243 at 24 months. The incidence of chlamydia in men was 2.0 per 100 person years both from baseline to 12 months and from 12 to 24 months, and in women, 4.6 from baseline to 12 months and 3.6 from 12 to 24 months; a range of 31.2% to 100% reported no symptoms across the 5 countries. The incidence of gonorrhea in men was 0.3 per 100 person years both from baseline to 12 months and from 12 to 24 months, and in women, 1.4 from baseline to 12 months and 1.1 from 12 to 24 months; a range of 66.7% to 100% reported no symptoms. Being female, aged 18 to 24 years, and having more than 1 partner were associated with both the infections. In addition, being divorced, separated, or widowed was associated with gonorrhea. Being male, having 6+ years of education, and reporting only 1 partner were associated with having no symptoms among those infected with chlamydia. No variables correlated with asymptomatic gonorrhea among those infected. A high prevalence and incidence of asymptomatic sexually transmitted infections was identified among men and women in a wide variety of settings. More effective programs are needed to identify and treat chlamydia and gonorrhea infections, especially among women, young adults, those with multiple partners, those repeatedly infected, and particularly those at risk without symptoms. The risk of transmission from persons with no symptoms requires further study.
              Article 0 comments Cited 67 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): Eur J Microbiol Immunol (Bp)
                Journal ID (iso-abbrev): Eur J Microbiol Immunol (Bp)
                Journal ID (publisher-id): EUJMI
                Title: European Journal of Microbiology & Immunology
                Publisher: Akadémiai Kiadó (Budapest )
                ISSN (Print): 2062-509X
                ISSN (Electronic): 2062-8633
                Publication date (Electronic): 11 September 2017
                Publication date Collection: September 2017
                Volume: 7
                Issue: 3
                Pages: 176-186
                Affiliations
                [1 ] Medical and Scientific Affairs, Roche Molecular Diagnostics , Pleasanton, CA, USA
                [2 ] Development, Roche Molecular Diagnostics, Inc. , Pleasanton, CA, USA
                [3 ] Bioscientia , Ingelheim, Germany
                [4 ] Amedes MVZ Wagnerstibbe für Laboratoriumsmedizin, Hämostaseologie , Humangenetik und Mikrobiologie, Hannover, Germany
                [5 ] Development, Roche Molecular Diagnostics , Rotkreuz, Switzerland
                Author notes
                * Medical and Scientific Affairs, Roche Molecular Diagnostics, Pleasanton, CA, USA; +19257308006; +19257308985; oliver.liesenfeld@ 123456roche.com
                Article
                DOI: 10.1556/1886.2017.00018
                PMC ID: 5632745
                PubMed ID: 29034107
                SO-VID: fb844102-9e45-4cd3-840e-9bb042e7eee2
                Copyright © © 2017, The Author(s)
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License ( https://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted use, distribution, and reproduction in any medium for non-commercial purposes, provided the original author and source are credited, a link to the CC License is provided, and changes – if any – are indicated.

                History
                Date received : 17 July 2017
                Date accepted : 14 August 2017
                Page count
                Figures: 2, Tables: 4, Equations: 0, References: 31, Pages: 11
                Categories
                Subject: Original Article

                Keywords: cobas®ct/ng,chlamydia trachomatis,neisseria gonorrhoeae,molecular diagnostics,pcr,extragenital infection,genital infection
                Data availability:
                Keywords: cobas®ct/ng, chlamydia trachomatis, neisseria gonorrhoeae, molecular diagnostics, pcr, extragenital infection, genital infection

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