cobas® CT/NG v2.0 Test

Product image for cobas® 4800 CT/NG Test

The simple path to accuracy

CT and NG multiplex assay with flexible order capability

A qualitative multiplex assay that simultaneously detects two CT independent DNA targets – one in the cryptic plasmid and the other on the CT genome. This design can detect infections caused by the wild type CT, the Swedish variant (nvCT), and other Chlamydia strains that may harbor deletions in the cryptic plasmid, or those that do not carry the cryptic plasmid.

DR-9, a direct repeat region and target of the NG assay, makes it highly specific to the NG species. No cross reactivity with commensal Neisseria or other bacterial species has been observed with the NG assay.

Features and benefits

Easy to learn, easy to use
 
  • The dual-target approach of cobas® CT/NG for both the genomic and cryptic plasmid DNA of C. trachomatis enables the detection of all major serovars of CT and 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.
 
Reliable results
 
  • Automated result algorithm provides clear positive, negative or invalid results.

 

Quality control in every step
 
  • An internal control utilizing an identical randomized internal target sequence is added to each sample and used throughout the entire process, from sample preparation to amplification and detection.
  • The internal control minimizes the risk of false negative results due to inhibition.
  • The AmpErase enzyme minimizes the risk of false positive results by degrading previously amplified targets allowing sample preparation and detection in the same lab.

Intended use

 

This test is an in vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) in patient specimens.* The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae. This test is intended to be used as a diagnostic as well as a screening tool.

*For a list of approved specimen types, please contact your local Roche representative.

Registration status

US-IVD