Stool Bacterial Pathogens Panel

Great Basin is developing an automated, qualitative DNA multiplex assay that rapidly detects common bacterial pathogens directly from a patient’s preserved stool sample. This syndromic panel simultaneously detects and differentiates specific gene targets from the most prevalent bacterial causes of acute gastroenteritis:

  • Salmonella
  • Shigella
  • Campylobacter (C. jejuni and C. coli)
  • Shiga toxin-producing E. coli (stx1 and stx2 genes)
  • E. coli serotype O157 (if Shiga toxin detected)

Need for Testing

The Centers for Disease Control and Prevention (CDC) estimates roughly 48 million Americans develop foodborne illnesses each year. Foodborne intestinal infection can progress to severe or disseminated gastroenteritis. While rapid EIA methods exist for some of the causative agents of gastroenteritis, labs must still rely on slow and labor-intensive culture for identification of the remaining pathogens. Beal, et al. found that while negative cultures with no potential pathogens were reported at 48 hours, positive cultures required 72 to 96 hours to finalize. They conclude that a rapid enteric panel for the molecular detection of stool bacterial pathogens might generate faster results, reduce costs, and allow technologists to spend time evaluating other more complex samples.[1] For the elderly and children under five, foodborne infections can be fatal. Fast and accurate detection is crucial to ensure effective and speedy treatment, and avoiding clinical interventions that could worsen the patient’s condition.

Advantages of Great Basin’s Stool Bacterial Pathogens Panel

  • Streamlined workflow: simultaneous detection of prevalent foodborne pathogens directly from patient’s preserved stool specimen
  • Ease of use: less than 2 minutes of hands-on time in the lab
  • Fast turn around time: electronically displays diagnostic results in under 2 hours to expedite differential diagnosis
  • Actionable results: a right size syndromic panel focused on the most common foodborne bacterial pathogens

The Great Basin Platform

Great Basin’s Platform employs an integrated disposable cartridge containing all necessary reagents; and a bench-top analyzer that executes the assay, interprets the results and provides an electronic display of the diagnostic call to the technician.

  • True sample-to-result with less than 2 minutes of hands-on time
  • On-demand testing; no batching of tests that delay results
  • Capable of multiplexing up to 64 distinct targets in a single assay
  • Innovative closed system to minimize contamination
  • Results in under 2 hours for all assays

Stool Bacterial Pathogens Panel sample-to-result assay

  • Simultaneously detects Salmonella, Shigella, Campylobacter (C. jejuni and C. coli), Shiga toxin-producing E. coli (stx1 and stx2 genes and E. coli serotype O157)
  • No sample prep, heat blocking, centrifugation or walk-away steps —process directly from patient’s preserved stool sample
  • Actionable results with an affordable syndromic panel
  • Promotes antimicrobial stewardship

Product availability based on timing of FDA 510(K) clearance in US

[1] BEAL, S., Evaluation of costs, technologists time and turn-around times for conventional stool cultures. As presented at the 113th General Meeting, American Society for Microbiology Denver, CO May 2013