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 affect 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.

The Great Basin Shiga Toxin Direct Test is a qualitative in vitro diagnostic assay of Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes and specific identification of a conserved genetic region of the Escherichia coli O157 serogroup from Cary-Blair or C&S Medium preserved stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis, or colitis. Shiga toxin genes are found in Shiga toxin-producing strains of E. coli (STEC) and Shigella dysenteriae. The E. coli O157 test result is only reported if a Shiga toxin gene is also detected.

The assay is intended for use in conjunction with clinical presentation as an aid in the diagnosis of STEC infections. Positive results do not rule out co-infection with other organisms, and may not be the definitive cause of patient illness.

The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Negative Shiga Toxin Direct Test results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn’s disease.

This in vitro diagnostic test is configured for use on Great Basin Analyser with Great Basin Shiga Toxin Direct Test Cartridge Kit.

Faster Clinical Decision Making and Improved Patient Outcomes

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

Increased Lab Productivity

• Easy-to-use, sample-to-result, low plex assay
• No need for enriching step
• On-demand testing; no batching of tests that delay results

Increasing Laboratory Effectiveness

• Sample-to-result with less than <2 mins hands-on-time per sample
• Efficiency benefits to hospitals and shorter stays for patients
• Small instrument footprint

References

1. CDC: 2015 Final Pertussis Surveillance Report