Shiga Toxin Direct Test

The Great Basin Shiga Toxin Direct Test is a sample-to-result, automated, low-plex assay that detects Shiga toxin-producing E. coli directly from a patient’s stool sample. The assay detects stx1 and stx2, in addition to identifying the hypervirulent serotype O157. Unlike competing tests on the market, this assay does not require an enrichment step.

Need for Testing

According to a report published by the Centers for Disease Control (CDC), National Enteric Disease Surveillance: STEC Surveillance Overview, Shiga toxin-producing E. coli (STEC) also known as enterohemorrhagic E.coli (EHEC) or verocytotoxigenic E. coli (VTEC), causes 265,000 illnesses each year in the United States, with more than 3,600 hospitalizations and 30 deaths. STEC symptoms vary for each person but often include severe stomach cramps, diarrhea (often bloody), and vomiting. Some infections are very mild, but others are severe or even life threatening. The majority of STEC infections in the U.S. are caused by E. coli O157:H7 (~ 36%). The CDC estimates that 2-3% of patients infected by E. coli O157:H7 develop a life-threatening condition called hemolytic uremic syndrome (HUS) which is characterized by hemolytic anemia and renal failure. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die. STEC infections effect people of all ages however, the elderly, children (<5yrs) and immunocompromised patients are at a higher risk of developing severe illness. Prompt and accurate diagnosis is crucial because it may reduce the extent of kidney damage in these patients. Antibiotic therapy in STEC patients may result in more severe disease making early detection important to ensure proper treatment.

Advantage of the Great Basin’s Shiga Toxin Direct Assay over conventional culture methodology

Conventional laboratory based culture based testing for STEC is laborious and time-consuming. A definitive result can take 48-96 hours. The Great Basin Shiga Toxin Direct Test uses the polymerase chain reaction (PCR) to detect the genes that encode the toxins (stx1 and stx2) in addition to an O157 specific antigen marker. This testing methodology affords a faster turnaround time coupled with greater sensitivity in accurate detection of stx1 and stx2 genes along with O157 serotype in the diagnosis of STEC infections. This affords the physician definite diagnostic results in a faster timeframe, allowing them to make timely therapeutic and potentially life-saving patient management decisions.

The Great Basin System

Great Basin’s System employs 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.
• True sample-to-result with less than 3 minutes of hands-on time
• On-demand testing; no batching of tests that delay results

Shiga Toxin Direct Test sample-to-result assay

• Detects Shiga toxin 1 (stx1) and Shiga toxin 2 (stx2) producing E. coli directly from a patients stool sample with no enrichment step
• Makes a definitive identification of STEC by targeting the stx1 and stx2 genes
• Identifies the O157 serotype
• Actionable results: ensures that the physicians gets accurate diagnostic results in a fast timeframe, allowing them to make timely therapeutic and patient management decisions

For more information on the Great Basin Shiga Toxin Direct Test, or to purchase our system, please contact Great Basin Sales