Authors:
Elizabeth M. Marlowe Roche Molecular Diagnostics, Pleasanton, CA, USA

Search for other papers by Elizabeth M. Marlowe in
Current site
Google Scholar
PubMed
Close
,
David Hardy Roche Molecular Diagnostics, Inc., Pleasanton, CA, USA

Search for other papers by David Hardy in
Current site
Google Scholar
PubMed
Close
,
Mark Krevolin Roche Molecular Diagnostics, Inc., Pleasanton, CA, USA

Search for other papers by Mark Krevolin in
Current site
Google Scholar
PubMed
Close
,
Peter Gohl Bioscientia, Ingelheim, Germany

Search for other papers by Peter Gohl in
Current site
Google Scholar
PubMed
Close
,
Alexander Bertram Amedes MVZ Wagnerstibbe für Laboratoriumsmedizin, Hämostaseologie, Humangenetik und Mikrobiologie, Hannover, Germany

Search for other papers by Alexander Bertram in
Current site
Google Scholar
PubMed
Close
,
Rodney Arcenas Roche Molecular Diagnostics, Pleasanton, CA, USA

Search for other papers by Rodney Arcenas in
Current site
Google Scholar
PubMed
Close
,
Britta Seiverth Roche Molecular Diagnostics, Rotkreuz, Switzerland

Search for other papers by Britta Seiverth in
Current site
Google Scholar
PubMed
Close
,
Tanja Schneider Roche Molecular Diagnostics, Rotkreuz, Switzerland

Search for other papers by Tanja Schneider in
Current site
Google Scholar
PubMed
Close
, and
Oliver Liesenfeld Roche Molecular Diagnostics, Pleasanton, CA, USA

Search for other papers by Oliver Liesenfeld in
Current site
Google Scholar
PubMed
Close
Open access

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.

  • 1.

    Detels R , Green AM, Klausner JD, Katzenstein D, Gaydos C, Handsfield H, Pequegnat W, Mayer K, Hartwell TD, Quinn TC: The incidence and correlates of symptomatic and asymptomatic Chlamydia trachomatis and Neisseria gonorrhoeae infections in selected populations in five countries. Sex Transm Dis 38, 503509 (2011)

    • Search Google Scholar
    • Export Citation
  • 2.

    Newman L , Rowley J, Vander Hoorn S, Wijesooriya NS, Unemo M, Low N, Stevens G, Gottlieb S, Kiarie J, Temmerman M: Global estimates of the prevalence and incidence of four curable sexually transmitted infections in 2012 based on systematic review and global reporting. PLoS One 10, e0143304 (2015)

    • Search Google Scholar
    • Export Citation
  • 3.

    Price MJ , Ades AE, De Angelis D, Welton NJ, Macleod J, Soldan K, Simms I, Turner K, Horner PJ: Risk of pelvic inflammatory disease following Chlamydia trachomatis infection: analysis of prospective studies with a multistate model. Am J Epidemiol 178, 484492 (2013)

    • Search Google Scholar
    • Export Citation
  • 4.

    Gottlieb SL , Xu F, Brunham RC: Screening and treating Chlamydia trachomatis genital infection to prevent pelvic inflammatory disease: interpretation of findings from randomized controlled trials. Sex Transm Dis 40, 97102 (2013)

    • Search Google Scholar
    • Export Citation
  • 5.

    Rekart ML , Gilbert M, Meza R, Kim PH, Chang M, Money DM, Brunham RC: Chlamydia public health programs and the epidemiology of pelvic inflammatory disease and ectopic pregnancy. J Infect Dis 207, 3038 (2013)

    • Search Google Scholar
    • Export Citation
  • 6.

    Romoren M , Hussein F, Steen TW, Velauthapillai M, Sundby J, Hjortdahl P, Kristiansen IS: Costs and health consequences of chlamydia management strategies among pregnant women in sub-Saharan Africa. Sex Transm Infect 83, 558566 (2007)

    • Search Google Scholar
    • Export Citation
  • 7.

    Sexton J , Garnett G, Rottingen JA: Metaanalysis and metaregression in interpreting study variability in the impact of sexually transmitted diseases on susceptibility to HIV infection. Sex Transm Dis 32, 351357 (2005)

    • Search Google Scholar
    • Export Citation
  • 8.

    Workowski KA , Bolan GA, Centers for Disease C, Prevention: Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep 64, 1137 (2015)

    • Search Google Scholar
    • Export Citation
  • 9.

    Kent CK , Chaw JK, Wong W, Liska S, Gibson S, Hubbard G, Klausner JD: 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. Clin Infect Dis 41, 6774 (2005)

    • Search Google Scholar
    • Export Citation
  • 10.

    Annan NT , Sullivan AK, Nori A, Naydenova P, Alexander S, McKenna A, Azadian B, Mandalia S, Rossi M, Ward H, Nwokolo N: Rectal chlamydia — a reservoir of undiagnosed infection in men who have sex with men. Sex Transm Infect 85, 176179 (2009)

    • Search Google Scholar
    • Export Citation
  • 11.

    Gunn RA , O’Brien CJ, Lee MA, Gilchick RA: Gonorrhea screening among men who have sex with men: value of multiple anatomic site testing, San Diego, California, 1997–2003. Sex Transm Dis 35, 845848 (2008)

    • Search Google Scholar
    • Export Citation
  • 12.

    Ota KV , Fisman DN, Tamari IE, Smieja M, Ng LK, Jones KE, Diprima A, Richardson SE: Incidence and treatment outcomes of pharyngeal Neisseria gonorrhoeae and Chlamydia trachomatis infections in men who have sex with men: a 13-year retrospective cohort study. Clin Infect Dis 48, 12371243 (2009)

    • Search Google Scholar
    • Export Citation
  • 13.

    Schachter J , Moncada J, Liska S, Shayevich C, Klausner JD: Nucleic acid amplification tests in the diagnosis of chlamydial and gonococcal infections of the oropharynx and rectum in men who have sex with men. Sex Transm Dis 35, 637642 (2008)

    • Search Google Scholar
    • Export Citation
  • 14.

    Centers for Disease Control and Prevention: Recommendations for the laboratory-based detection of Chlamydia trachomatis and Neisseria gonorrhoeae — 2014. MMWR Recomm Rep 63, 119 (2014)

    • Search Google Scholar
    • Export Citation
  • 15.

    Javanbakht M , Gorbach P, Stirland A, Chien M, Kerndt P, Guerry S: Prevalence and correlates of rectal chlamydia and gonorrhea among female clients at sexually transmitted disease clinics. Sex Transm Dis 39, 917922 (2012)

    • Search Google Scholar
    • Export Citation
  • 16.

    van Liere GA , Hoebe CJ, Wolffs PF, Dukers-Muijrers NH: High co-occurrence of anorectal chlamydia with urogenital chlamydia in women visiting an STI clinic revealed by routine universal testing in an observational study; a recommendation towards a better anorectal chlamydia control in women. BMC Infect Dis 14, 274 (2014)

    • Search Google Scholar
    • Export Citation
  • 17.

    van Liere G , Dukers-Muijrers N, Levels L, Hoebe C: High proportion of anorectal Chlamydia trachomatis and Neisseria gonorrhoeae after routine universal urogenital and anorectal screening in women visiting the sexually transmitted infection clinic. Clin Infect Dis 64, 17051710 (2017)

    • Search Google Scholar
    • Export Citation
  • 18.

    Volk JE , Marcus JL, Phengrasamy T, Blechinger D, Nguyen DP, Follansbee S, Hare CB: No new HIV infections with increasing use of HIV preexposure prophylaxis in a clinical practice setting. Clin Infect Dis 61, 16011603 (2015)

    • Search Google Scholar
    • Export Citation
  • 19.

    Van Der Pol B : Cobas(R) 4800: a fully automated system for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae. Expert Rev Mol Diagn 13, 131140 (2013)

    • Search Google Scholar
    • Export Citation
  • 20.

    Van Der Pol B , Liesenfeld O, Williams JA, Taylor SN, Lillis RA, Body BA, Nye M, Eisenhut C, Hook EW 3rd: Performance of the cobas CT/NG test compared to the Aptima AC2 and Viper CTQ/GCQ assays for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol 50, 22442249 (2012)

    • Search Google Scholar
    • Export Citation
  • 21.

    Van Der Pol B , Taylor SN, Liesenfeld O, Williams JA, Hook EW, 3rd: Vaginal swabs are the optimal specimen for detection of genital Chlamydia trachomatis or Neisseria gonorrhoeae using the Cobas 4800 CT/NG test. Sex Transm Dis 40, 247250 (2013)

    • Search Google Scholar
    • Export Citation
  • 22.

    Taylor SN , Liesenfeld O, Lillis RA, Body BA, Nye M, Williams J, Eisenhut C, Hook EW 3rd, Van Der Pol B: Evaluation of the Roche cobas(R) CT/NG test for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in male urine. Sex Transm Dis 39, 543549 (2012)

    • Search Google Scholar
    • Export Citation
  • 23.

    Cobb B , Simon CO, Stramer SL, Body B, Mitchell PS, Reisch N, Stevens W, Carmona S, Katz L, Will S, Liesenfeld O: The cobas(R) 6800/8800 System: a new era of automation in molecular diagnostics. Expert Rev Mol Diagn 17, 167180 (2017)

    • Search Google Scholar
    • Export Citation
  • 24.

    Zaninotto M , Plebani M: The “hospital central laboratory”: automation, integration and clinical usefulness. Clin Chem Lab Med 48, 911917 (2010)

    • Search Google Scholar
    • Export Citation
  • 25.

    Ledeboer NA , Dallas SD: The automated clinical microbiology laboratory: fact or fantasy? J Clin Microbiol 52, 31403146 (2014)

  • 26.

    Kojima N , Davey DJ, Klausner JD: Pre-exposure prophylaxis for HIV infection and new sexually transmitted infections among men who have sex with men. AIDS 30, 22512252 (2016)

    • Search Google Scholar
    • Export Citation
  • 27.

    Jenness SM , Weiss KM, Goodreau SM, Gift T, Chesson H, Hoover KW, Smith DK, Liu AY, Sullivan PS, Rosenberg ES: Incidence of gonorrhea and chlamydia following HIV preexposure prophylaxis among men who have sex with men: a modeling study. Clin Infect Dis 65, 712718 (2017), DOI: 10.1093/cid/cix439 (2017)

    • Search Google Scholar
    • Export Citation
  • 28.

    US Public Health Service Preexposure prophylaxis for the prevention of HIV infection in the United States — 2014: a clinical practice guideline. https://wwwcdcgov/hiv/pdf/prepguidelines2014pdf (2014)

  • 29.

    Tabrizi SN , Unemo M, Limnios AE, Hogan TR, Hjelmevoll SO, Garland SM, Tapsall J: Evaluation of six commercial nucleic acid amplification tests for detection of Neisseria gonorrhoeae and other Neisseria species. J Clin Microbiol 49, 36103615 (2011)

    • Search Google Scholar
    • Export Citation
  • 30.

    Upton A , Bromhead C, Whiley DM: Neisseria gonorrhoeae false-positive result obtained from a pharyngeal swab by using the Roche cobas 4800 CT/NG assay in New Zealand in 2012. J Clin Microbiol 51, 16091610 (2013)

    • Search Google Scholar
    • Export Citation
  • 31.

    Bohm I , Groning A, Sommer B, Muller HW, Krawczak M, Glaubitz R: A German Chlamydia trachomatis screening program employing semi-automated real-time PCR: results and perspectives. J Clin Virol 46 (Suppl 3), S27S32 (2009)

    • Search Google Scholar
    • Export Citation
  • Collapse
  • Expand

Senior editors

Editor(s)-in-Chief: Dunay, Ildiko Rita, Prof. Dr. Pharm, Dr. rer. nat., University of Magdeburg, Germany

Editor(s)-in-Chief: Heimesaat, Markus M., Prof. Dr. med., Charité - University Medicine Berlin, Germany

Editorial Board

  • Berit Bangoura, Dr. DVM. PhD,  University of Wyoming, USA
  • Stefan Bereswill, Prof. Dr. rer. nat., Charité - University Medicine Berlin, Germany
  • Dunja Bruder, Prof. Dr. rer. nat., University of Magdeburg, Germany
  • Jan Buer, Prof. Dr. med., University of Duisburg, Germany
  • Edit Buzas, Prof. Dr. med., Semmelweis University, Hungary
  • Renato Damatta, Prof. PhD, UENF, Brazil
  • Maria Deli, MD, PhD, DSc, Biological Research Center, HAS, Hungary
  • Olgica Djurković-Djaković, Prof. Phd, University of Belgrade, Serbia
  • Jean-Dennis Docquier, Prof. Dr. med., University of Siena, Italy
  • Zsuzsanna Fabry, Prof. Phd, University of Washington, USA
  • Ralf Ignatius, Prof. Dr. med., Charité - University Medicine Berlin, Germany
  • Achim Kaasch, Prof. Dr. med., Otto von Guericke University Magdeburg, Germany
  • Oliver Liesenfeld, Prof. Dr. med., Inflammatix, USA
  • Matyas Sandor, Prof. PhD, University of Wisconsin, USA
  • Ulrich Steinhoff, Prof. PhD, University of Marburg, Germany
  • Michal Toborek, Prof. PhD, University of Miami, USA
  • Susanne A. Wolf, PhD, MDC-Berlin, Germany

 

Dr. Dunay, Ildiko Rita
Magdeburg, Germany
E-mail: ildiko.dunay@med.ovgu.de

Indexing and Abstracting Services:

  • PubMed Central
  • Scopus
  • ESCI
  • CABI
  • CABELLS Journalytics

 

2023  
Web of Science  
Total Cites
WoS
674
Journal Impact Factor 3.3
Rank by Impact Factor

Q2

Impact Factor
without
Journal Self Cites
3.1
5 Year
Impact Factor
3.2
Scimago  
Scimago
H-index
15
Scimago
Journal Rank
0.601
Scimago Quartile Score Microbiology (medical) (Q2)
Microbiology (Q3)
Immunology and Allergy (Q3)
Immunology (Q3)
Scopus  
Scopus
Cite Score
5.0
Scopus
CIte Score Rank
Microbiology (medical) Q2
Scopus
SNIP
0.832

 

European Journal of Microbiology and Immunology
Publication Model Gold Open Access
Online only
Submission Fee none
Article Processing Charge

600 EUR/article

Effective from 1st Jan 2025: 900 EUR/article

Regional discounts on country of the funding agency World Bank Lower-middle-income economies: 50%
World Bank Low-income economies: 100%
Further Discounts Editorial Board / Advisory Board members: 50%
Corresponding authors, affiliated to an EISZ member institution subscribing to the journal package of Akadémiai Kiadó: 100%
Subscription Information Gold Open Access
Purchase per Title  

European Journal of Microbiology and Immunology
Language English
Size A4
Year of
Foundation
2011
Volumes
per Year
1
Issues
per Year
4
Founder Akadémiai Kiadó
Founder's
Address
H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
Publisher Akadémiai Kiadó
Publisher's
Address
H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
Responsible
Publisher
Chief Executive Officer, Akadémiai Kiadó
ISSN 2062-509X (Print)
ISSN 2062-8633 (Online)

Monthly Content Usage

Abstract Views Full Text Views PDF Downloads
May 2024 0 19 2
Jun 2024 0 21 11
Jul 2024 0 12 6
Aug 2024 0 21 7
Sep 2024 0 43 11
Oct 2024 0 108 7
Nov 2024 0 23 0