Supporting Your Strep A Diagnosis

 

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 Clinical symptoms overlap with other diseases. Providing early diagnosis can aid with a reduction in further complications by use of appropriate antibiotics being prescribed due to an accurate diagnosis.2
Help patients get the treatment and relief they need faster with the reliable accuracy of the cobas® Strep A Test.*

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The cobas® Liat® PCR System vs. Conventional methods

Signs &
symptoms


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Conventional
methods


Strep A Test Menu

cobas®
Strep A test


 

Intended use for cobas® Strep A test4

The cobas® Strep A nucleic acid test for use on the cobas® Liat® System is a real-time PCR assay for the detection of Streptococcus pyogenes (Group A β-hemolytic Streptococcus, Strep A) in throat swab specimens from patients with signs and symptoms of pharyngitis.
The cobas® Strep A assay utilizes nucleic acid purification and PCR technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome.
CE-IVD and FDA 510(k) cleared; CLIA waived. This product is not registered as an in vitro diagnostic (IVD) in all countries; additional information may be available from your Roche sales representative.

 
 
 

Learn more about the expanding menus of assays

CI=confidence intervals. LOD=limit of detection. CFU=colony-forming unit.
*PCR and sequencing show that all culture negative, cobas® Liat® System positive samples were actually positive for Strep A and that all cobas® Liat® System negative culture positive specimens were proven positive by PCR/Sequencing.
**Guidelines suggest negative RADT be confirmed.



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. Cunningham MW. Clin Microbiol Rev. 2000;13(3):470-511. 3. Shulman ST, et al. Clin Infect Dis. 2012;55(10):1279-82. 4. cobas® Strep A [package insert]. Pleasanton, CA: Roche Molecular Systems, Inc., 2016.