The New TECHLAB Shiga Toxin E. coli Rapid Test Receives FDA Clearance

Alere Inc., a global leader in rapid diagnostics and health management, has announced U.S. Food and Drug Administration (FDA) clearance for 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, Inc.,” 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.”

Shiga toxin-producing E. coli are commonly associated with food- and water-borne outbreaks of diarrheal illness. Shiga Toxin 1 and Shiga Toxin 2, produced singly or in combination by more than 200 different strains of STEC, are the enterohemorrhagic toxins that cause disease. O157 is the most well known strain and has been responsible for numerous outbreaks in the past. Several other strains, though, have led to severe outbreaks, and SHIGA TOXIN QUIK CHEK detects toxins from both O157 and non-O157 strains. If left untreated, STEC infections can lead to severe complications such as hemolytic uremic syndrome (HUS), an often fatal condition characterized by renal failure and hemolytic anemia. Rapid identification of STEC is vital to help prevent complications like HUS.

The SHIGA TOXIN QUIK CHEK is the newest addition to the Alere Enterics suite of QUIK CHEK assays developed and manufactured by TECHLAB®, Inc. It combines the precise accuracy of an enzyme immunoassay with the speed and ease of use of a cassette. The SHIGA TOXIN QUIK CHEK requires few processing steps and provides differentiated results for Shiga Toxin 1 and 2 within 30 minutes of sample receipt, allowing for rapid diagnosis and prompt initiation of patient treatment. In addition to being cleared for use in the United States, the SHIGA TOXIN QUIK CHEK has received CE marking and available in other worldwide markets.