Answers at hand The cobas® 4800 CT/NG Test delivers · PDF fileThe cobas® 4800 CT/NG...

2
COBAS and LIFE NEEDS ANSWERS are trademarks of Roche. All other trademarks are the property of their respective owners. © 2014 Roche Molecular Systems, Inc. Roche Molecular Diagnostics 4300 Hacienda Drive Pleasanton, CA 94588 USA http://molecular.roche.com Answers at hand The cobas® 4800 CT/NG Test delivers highly accurate results with speed, confidence and efficiency Not for use in US Market xxxxxxxxxxx a 0000 - x.x XX Please contact your local Roche representative for ordering information. In 1993, Roche introduced its first-ever, FDA- cleared 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® CT/NG Test makes it easier to deliver faster, more reliable and more accurate answers. Because your needs inspire our innovation.

Transcript of Answers at hand The cobas® 4800 CT/NG Test delivers · PDF fileThe cobas® 4800 CT/NG...

COBAS and LIFE NEEDS ANSWERS are trademarks of Roche. All other trademarks are the property of their respective owners.

© 2014 Roche Molecular Systems, Inc.

Roche Molecular Diagnostics4300 Hacienda DrivePleasanton, CA 94588USAhttp://molecular.roche.com

Answers at handThe cobas® 4800 CT/NG Test delivers highly accurate results with speed, confidence and efficiency

Not for use in US Market

xxxx

xxxx

xxx

a 00

00-

x.x

XX

Please contact your local Roche representative for ordering information.

In 1993, Roche introduced its first-ever, FDA-

cleared 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® CT/NG Test makes it

easier to deliver faster, more reliable and more

accurate answers.

Because your needs inspire our innovation.

Dual target

Internal control

AmpErase

Confidence built in to every test

Efficient delivery of accurate results for clinicians and patientsChlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are among the most common sexually transmitted infections (STIs). The cobas® CT/NG test uses real-time PCR to test CT and NG simultaneously in the same sample, with highly accurate results, rapid turnaround and minimal hands-on time.

• Shorter hands-on time: Maximizes time producing patient results

• Low maintenance: Only 4 minutes per day

• Flexible run sizes: Maximize throughput and optimize reagent use with runs of 24, 48, 72 or 96 samples

• Rapid results: Generate the first 94 CT/NG results in less than 4.5 hours

Confident results, definitive answersUnique quality control measures built in to ensure confidence in patient results reported• The AmpErase enzyme reduces the risk of false positive results by destroying previously generated amplicon, eliminating the need to use bleach and greatly reducing maintenance time

• An internal control (IC) minimizes 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

• A proprietary Kinetic Algorithm provides clear, unambiguous results—with no grey zone

Put time on your side

Ready for today, ready for the futureThe cobas® 4800 System offers automated efficiency to manage daily workflows and the flexibility to adapt quickly to change • An expanding test menu allows you to run CT/NG tests on the same system used for cobas® HPV, MRSA/SA, Cdiff*, HSV 1 and 2, oncology and virology* tests—all with Roche-quality results• UserDefined (UDF) software opens the way for you to set up and automate laboratory-developed tests (LDTs) independent of the cobas® 4800 System assay menus

*In development for the cobas® 4800 System.

0 100 200 300 400 500

BD Viper™ System(92 reportable)

Abbott m2000(92 reportable)

Gen-Probe Tigris® DTS(96 reportable)

Gen-Probe PANTHER System(98 reportable)

cobas® 4800 System(94 reportable)

Hands-on time Daily maintenance Test cycle time

271.86

408.07

412.80

419.46

336.59

Minutes

Compared to competitive tests, the cobas® CT/NG Test has less hands-on time, lowest maintenance time and shortest test cycle time.*

The cobas® 4800 System is the only system that allows you to load primary vials for swab, urine and liquid-based cytology (LBC) samples directly onboard.

*Roche CT/NG System comparison Study, presented by Argent Global Services, August 2010.

Simplified workflow with primary vial loading for all sample types

De-cap primary vial and load

Fully automated sample extraction and result generation