CE Mark for Shiga Toxin Direct Test from Stool Samples
The Shiga Toxin Direct Test from Great Basin Scientific, Inc. is now CE marked and available for use outside of the U.S.. The CE marking now makes it qualified for distribution in more than 32 countries across Europe.
The Shiga Toxin Direct Test is the only standalone molecular test approved by the FDA, enabling the fast, precise detection of STEC from stool samples. Great Basin’s test aids a faster diagnosis and provides laboratory technicians with a streamlined workflow, enabling sample-to-result testing with less than one minute of hands-on time and no specimen enrichment step.
The Great Basin Shiga Toxin Direct Test is run directly from a patient’s stool sample with no enrichment step, making a definitive identification of STEC by detecting stx1 and stx2 genes, also identifying the O157 serotype. The test uses an integrated disposable cartridge containing all necessary reagents, and a bench-top analyzer that executes the assay, interprets the results and provides electronic output to the clinician.
Tags: Escherichia coli inc STECs, Escherichia coli O157
Date Published: July 5, 2016
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