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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

  • Reduces labor costs and training time
  • Intuitive software walks the user through the entire set up process
  • Bi-directional LIS connection protects results integrity and reduces repetitive tasks

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 degrades previously amplified targets, allowing sample prep and detection in the same lab

Intended Use

This test is an 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 andNeisseria 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.