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The primary purpose of this clinical investigation is to establish the performance of the GenePOC Strep A, C/G assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Group A β-hemolytic Streptococcus (GAS) and pyogenic Group C and G β-hemolytic Streptococcus (GCS/GGS) in throat swab samples.
Full description
The GenePOC Strep A, C/G assay will be performed using the revogene™ instrument. The revogene instrument, used in conjunction with appropriate reagents, is capable of automated cell lysis, dilution of nucleic acids from multiple sample types as well as automated amplification and detection of target nucleic acid sequences.
A dual swab sample is collected when ICF is signed by patient. One of the swab will be tested on the revogene™, and the second swab will be tested with standard microbiology method at a Reference Center.
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• Patient/sample not meeting inclusion criteria above
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497 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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