cobas® CT/NG Test

Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems

IVD For in vitro diagnostic use.
cobas CT/NG
Proven efficiency, giving you the freedom to do more

With STI rates on the rise1cobas® CT/NG on the cobas 5800/6800/8800 systems 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 Chlamydia 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 (DR-9) and a conserved sequence variant amplify and detect both wild type and variant versions of Neisseria gonorrhoeae.
     

Simplicity and flexibility to meet varying throughput and workflow requirements

  • Highest throughput molecular test for CT/NG on the market.
  • 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.

Chlamydia trachomatis

RMD_Chlamydia trachomatis

Neisseria gonorrhoeae

RMD_ Neisseria gonorrhoea
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Intended use

Intended use

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), and 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

US-IVD

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References

  1. U.S. STI Epidemic Showed No Signs of Slowing in 2021 – Cases Continued to Escalate. Centers for Disease Control and Prevention. https://www.cdc.gov/media/releases/2023/s0411-sti.html. (Accessed January 2023.)

Overview

Detailed Specifications

Ordering Information

Compatible Instruments

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