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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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          Most cited references 26

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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.

          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.

            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.
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              Nucleic acid amplification tests in the diagnosis of chlamydial and gonococcal infections of the oropharynx and rectum in men who have sex with men.

              Several nucleic acid amplification tests (NAATs) are US Food and Drug Administration-cleared for detecting urogenital Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) infection, but they have not been adequately evaluated for the relatively common oropharyngeal or rectal CT and GC infections in men who have sex with men (MSM). Multiple swabs were collected from the oropharynx and rectum of MSM attending a city sexually transmitted disease clinic. The specimens were tested by standard culture and the following NAATs: Roche's Amplicor (PCR), Becton Dickinson's ProbeTec (SDA), and Gen-Probe's APTIMA Combo 2 (AC2) for the detection of CT and GC. Confirmatory testing of specimens with discrepant results was done by NAATs using alternate primers. A total of 1110 MSM were enrolled. Based on initial findings on 205 MSM, PCR had a 78.9% GC specificity with oropharyngeal swabs. Thus, we discontinued PCR testing for the rest of the study. For oropharyngeal GC (89 infections detected), sensitivities were 41% for culture, 72% for SDA, and 84% for AC2. For rectal GC (88 infections detected), sensitivities were 43% for culture, 78% for SDA and 93% for AC2. For oropharyngeal CT (9 infections detected), sensitivities were 44% for culture, 67% for SDA, and 100% for AC2. For rectal CT (68 infections detected), sensitivities were 27% for culture, 63% for SDA, and 93% for AC2. Specificities of SDA and AC2 were > or =99.4% for both organisms and anatomical sites. AC2 and SDA were far superior to culture for the detection of CT or GC from the oropharynx and rectum with AC2 detecting twice as many infections as culture. Further analyses with larger pharyngeal samples are needed, but clearly NAATs can improve our ability to diagnose rectal and oropharyngeal infection with CT or GC in MSM.
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                Author and article information

                Journal
                Eur J Microbiol Immunol (Bp)
                Eur J Microbiol Immunol (Bp)
                EUJMI
                European Journal of Microbiology & Immunology
                Akadémiai Kiadó (Budapest )
                2062-509X
                2062-8633
                11 September 2017
                September 2017
                : 7
                : 3
                : 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
                10.1556/1886.2017.00018
                5632745
                © 2017, The Author(s)

                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.

                Page count
                Figures: 2, Tables: 4, Equations: 0, References: 31, Pages: 11
                Categories
                Original Article

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