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cobas® CT/NG

Proven efficiency, giving you the freedom to do more

Product image for cobas® CT/NG

Proven efficiency, giving you the freedom to do more

With STI rates on the rise, cobas® CT/NG provides a solution to meet the growing demand for CT/NG Testing, delivering exceptional assay performance, providing broader information for improved patient care decisions, and enabling simplicity and flexibility to support varying throughput and workflow requirements.

Features and benefits

Exceptional assay performance
 
  • The Dual-Target approach of cobas® CT/NG of both the genomic and cryptic plasmid DNA of C. trachomatis, ensures inclusion of nvCT strains for a highly sensitive test.
  • The use of two sets of primers targeting the highly conserved direct repeat region (DR9) and a conserved sequence variant amplify and detect both wild type and variant versions of N. gonorrhoeae.

 

Broader information for improved patient care decisions
 
  • Studies have shown that as high as 50% of infections may be missed in high risk male populations where patients were only tested using traditional urogenital specimens.1
  • cobas® CT/NG has been validated for use with anorectal and oropharyngeal swab specimens enabling laboratories to test for infections in extragenital specimens with increased confidence.

 

Simplicity and flexibility to meet varying throughput and workflow requirements
 
  • Highest throughput molecular test for CT/NG on the market.
  • Onboard capacity of up to 5,670 CT/NG Tests with onboard stability of 90 days.
  • Continuous loading of samples with no pre-sorting required for mixed test requests.
  • Simultaneous processing of multiple tests from the same patient sample.
  • Full automation and process control of all STI tests onto a single platform including LDTs­­.
Intended use

Intended use

The cobas® CT/NG for use on the cobas® 5800/6800/8800 Systems is an automated, qualitative in vitro nucleic diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in male and female urine, clinician-instructed self-collected vaginal swab specimens, clinician-collected vaginal swab specimens, endocervical swab specimens, oropharyngeal (throat) and anorectal swab specimens, all collected in cobas® PCR Media (Roche Molecular Systems, Inc.), and cervical specimens collected in PreservCyt® Solution. This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals.

cobas® CT/NG for use on the cobas® 5800/6800/8800 Systems is an automated, qualitative in vitro nucleic acid diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in male and female urine, clinician-instructed self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, endocervical swab specimens, oropharyngeal (throat) swab specimens and anorectal swab specimens all collected in cobas® PCR Media (Roche Molecular Systems, Inc.), and cervical specimens collected in PreservCyt® Solution. This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals.

 

Registration status

CE-IVD, US-IVD

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

References

  1. Recommendations for the Laboratory-Based Detection of Chlamydia trachomatis and Neisseria gonorrhoeae — 2014, Recommendations and Reports / Vol. 63 / No. 2 March 14, 2014, pgs 10-11.