cobas® Strep A Assay

Product image for cobas® Strep A Assay

No confirmatory testing*

Strep A is responsible for over 600 million cases of pharyngitis annually. On a global scale, GAS is an important cause of morbidity and mortality.1 The infection presents similar symptoms to other illnesses in the early stages, so providing patients with the correct diagnosis earlier can help prevent complications or the unnecessary use of antibiotics.

A real-time polymerase chain reaction (PCR) test for the detection of Strep A in throat swab specimens from patients with signs and symptoms of pharyngitis, cobas® Strep A delivers labquality results in ~15 minutes.

Help patients get the treatment and relief they need faster with the reliable accuracy of the cobas® Strep A Test.2

 

*Note: The cobas® Strep A assay is a rapid and easy to use molecular test that provides improved sensitivity over RADT, eliminating the need for confirmatory culture testing in adults and children.2

cobas® Influenza Strep A performance

Influenza chart

Intended use

The cobas® Strep A Nucleic acid test for use on the cobas® Liat System (cobas® Liat Strep A) is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes A (Group β-hemolytic Streptococcus, Strep A) in throat swab specimens from patients with signs and symptoms of pharyngitis. The cobas® Liat Strep A Assay utilizes nucleic acid purification and polymerase chain reaction (PCR) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome.

The cobas® Liat® System is commercially available in select markets. This product is not registered as an in vitro diagnostic (IVD) in all countries; additional information may be available from your Roche sales representative.

Registration status

CE-IVD, FDA 510(k) cleared, CLIA waived

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

References

 

1. Carapetis JR, Steer AC, Mulholland EK, Weber, M. The global burden of group A streptococcal diseases. Lancet Infect Dis. 2005:5(11);685-694. 
 
2. cobas® Strep A [package insert]. Pleasanton, CA: Roche Molecular Systems, Inc., 2016.
 
3. Cunningham MW. Clin Microbiol Rev. 2000;13(3):470-511.

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cobas® Liat® System

The cobas® Liat® System is a fast, easy-to-use, compact PCR system designed for on-demand testing in point-of-care* settings such as physician clinics, pharmacy, and...

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