Rapid Shiga Toxin Diagnostic Assay

Area of Research

Bethesda, MD
United States


The most dangerous E. coli that cause enteric (or intestinal) diseases in humans are those associated with Shiga toxin-producing E. coli (STEC), which are responsible for approximately 265,000 infections per year in the United States. In order to best treat illness, an appropriate and timely diagnosis is required.

Technology developed at the Uniformed Services University of the Health Sciences (USU) addresses those issues to detect Shiga toxin produced strains of E. coli and patent protection was obtained for the direct detection in food and in clinical samples.

HJF licensed these patents to Inverness Medical Innovations, Inc. (since acquired by Alere and now Abbott) for the development of the of the Shiga toxin technology diagnostic. Following the license, a CRADA was entered into amongst Alere (now Abbott), TechLab®, HJF, and USU, with the CRADA establishing a collaboration effort that enabled the commercial partners to access the knowledge of the USU inventors and utilize critical reagents to develop the next-generation Shiga toxin diagnostic assay.

There are currently two commercial products based on this technology: Shiga Toxin Quik ChekTM and Shiga Toxin ChekTM, manufactured by TechLab.


Four quadrant explanation of Shiga Toxin Diagnostic Assay