Alere Inc., a leader in rapid diagnostics and health management, recently received confirmation that the U.S. Food and Drug Administration (FDA) has cleared the TECHLAB SHIGA TOXIN QUIK CHEK test for the U.S. market.
SHIGA TOXIN QUIK CHEK is the only rapid diagnostic available that can detect Shiga toxin-producing E. coli (STEC), which can have fatal effects, directly from a stool specimen. The test offers significant advantages over other rapid cassette assays in that it removes the need for overnight bacterial culture preparation. The SHIGA TOXIN QUIK CHEK provides results up to 24 hours before other rapid tests, enabling clinicians to initiate patient care sooner and minimize the potential for broader bacterial outbreaks. The test's considerably shorter sample preparation process also helps to dramatically streamline laboratory workflows.
"The recent FDA clearance of our new Shiga Toxin E. coli test enhances Alere's position as a market leader for enteric disease diagnostics and is a testament to our strong partnership with TECHLAB," said Jim Post, president of Alere North America. "By narrowing the diagnostic window from a day to 30 minutes, the SHIGA TOXIN QUIK CHEK promises to be a significant help to clinicians, facilitating more rapid patient care that leads to better outcomes, improving workflows, and reducing the potential for broader outbreaks."