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    cobas® 4800 CT/NG Test 

    Answers at hand

Paving the way for improved CT/NG testing

In 1993, Roche introduced its first-ever, FDA-cleared polymerase chain reaction (PCR) test — a molecular test for CT. Three years later, Roche introduced a CT/NG test with internal controls. 

With every generation, Roche has continued to improve CT/NG testing through advances in automation and accuracy. Today, the latest generation cobas® 4800 CT/NG Test* makes it easier to deliver faster, more reliable and more accurate answers.

*Not available in all markets


The cobas® 4800 CT/NG Test delivers highly accurate results 

Test Overview

cobas 4800 ct ng test detection

Confidence built into every test

Confident results, definitive answers

The cobas® 4800 CT/NG Test uses real-time PCR to test CT and NG simultaneously in the same sample, with highly accurate results, rapid turnaround time, and minimal hands-on time. The test has unique quality control measures built in to ensure confidence in patient results reported.


The cobas® 4800 CT/NG Test:

  • Reduces the risk of false positive results with the AmpErase enzyme. The enzyme destroys previously generated amplicon, eliminating the need to use bleach and greatly reducing maintenance time.
  • Uses an internal control to minimize false negative results due to inhibition
  • Delivers robust performance with accurate detection of two independent CT DNA targets and two highly conserved NG DNA sequence variations 
  • Provides clear, unambiguous results with no grey zone with analysis by a proprietary kinetic algorithm
  • Adds to the expanded STI test menu on the cobas®  4800 System, which also includes Herpes Simplex Virus (HSV) testing 

 

Test Performance

Optimized CT/NG detection among all specimen types

Analytical Sensitivity

The Limit of Detection (LOD), defined as the target concentration which can be detected as positive in ≥95% of the replicates tested, is as low as 3.00 IFU/mL (CT), 9.00 CFU/mL (NG) in stabilized swab specimens and 0.75 IFU/mL (CT), 2.25 CFU/mL (NG) in stabilized urine specimens.

 

Analytical Specificity

A panel of 184 microorganisms, including those commonly found in the urogenital tract, were tested with the cobas® 4800 CT/NG Test to assess for analytical specificity. None of these organisms interfered with the detection of CT and NG and no false positives were produced.

 

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  CT NG
Sample Type N Sens. % Spec. % N Sens.% Spec. %
Endocervical 4,316 91.6 99.8 4,316 95.6 100.0
Female Urine 4,316 92.3 99.8 4,316 98.5 99.9
Male Urine 768 97.6 99.5 768 100.0 99.7
Self-Collected Vaginal 2,083

95.9 99.4 2,083 100.0 100.0
Clinician-Collected Vaginal 2,165 94.6 99.7 2,164 97.0 100.0
PreservCyt® Pre-ThinPrep 4,236 92.8 99.6 4,239 97.1 99.9
PreservCyt® Post-ThinPrep 4,202

89.7 99.7 4,203 95.7 100.0

* Results based on the VENUS Study, the largest clinical trial of its kind for the detection of CT/NG.

The VENUS studies included over 5,000 patients. Performance data applies to cobas® 4800 CT/NG test only.

Rapid turnaround time and minimal hands-on time

Sample Preparation

Load primary vials for all sample types

The cobas® 4800 System is the only system that allows labs to load primary vials for swab, urine, and liquid-based cytology (LBC) samples directly onboard. In addition, the system allows for flexible run sizes, maximizing throughput and optimizing reagent use with runs of 24, 48, 72, or 96 samples.  

cobas 4800 Ssystem primary vial loading workflow

Simplified workflow with primary vial loading for all sample types 

Minimal Hands-on Time

Put time on your side

Compared to competitive tests, the cobas® 4800 CT/NG Test on the cobas® 4800 System has the least hands-on time, the lowest maintenance time, and the shortest test cycle time.1 Maintenance requires only 4 minutes a day and labs can generate the first 94 CT/NG results in less than 4.5 hours. 

* Presented by Argent Global Services, August 2010

The cobas® CT/NG Test requires less hands-on time, daily maintenance, and test cycle time vs. competitive tests 
 

Testing Flexibility

Ready for today, ready for the future

The cobas® 4800 System offers automated efficiency to manage daily workflows and the flexibility to adapt quickly to change. An expanding test menu allows labs to run CT/NG tests on the same system used for HPV, MRSA/SA, Cdiff, HSV 1 and 2, oncology and virology* tests—all with Roche-quality results.

 

Learn about the system ›

cobas-4800-system-loading
*In development for the cobas® 4800 System
Intended Use: The cobas® 4800 CT/NG 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 DNA in endocervical swab specimens, clinician-collected vaginal swab specimens, clinician-instructed self-collected vaginal swab specimens, and male and female urine in cobas® PCR Media (Roche Molecular Systems, Inc.), and cervical specimens in PreservCyt® Solution (Hologic, Inc.). This test is intended to be used as a diagnostic as well as a screening tool in both symptomatic and asymptomatic populations.
US users should visit our US site.
  • Acronyms:

References:

1. Roche CT/NG Comparison Study, presented by Argent Global Services, August 2010.