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
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:
Optimized CT/NG detection among all specimen types
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.
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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* 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.
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.
Simplified workflow with primary vial loading for all sample types
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.
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.
1. Roche CT/NG Comparison Study, presented by Argent Global Services, August 2010.