Great Basin Stool Bacterial Pathogens Panel

Multiplex and qualitative detection of enteric bacterial pathogens

RELEVANCE

The CDC estimates that there are approximately 48 million cases of foodborne illness in the US every year1.

Conventional laboratory methods require extensive hands-on labor and can take 3-4 days to produce a definitive result, delaying appropriate treatment and epidemiological efforts. Nearly 95% of all stool samples are negative, yet still require similar hands-on and incubation times as positive specimens.

Conventional bacterial stool culture is one of the more time-consuming tests in a routine clinical microbiology laboratory. In addition, less than 5% of stool cultures yield positive results.2

While rapid, molecular diagnostic solutions exist, these are often large panels containing extra analytes that are frequently considered “medically unnecessary” with payers, and with co-infections that are difficult to interpret.

INTENDED USE

The Great Basin Stool Bacterial Pathogens Panel is a multiplexed, qualitative test for the detection and identification of DNA targets of enteric bacterial pathogens directly from Cary Blair or C&S Medium preserved stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis, or colitis.

The Stool Bacterial Pathogens Panel detects nucleic acids from Campylobacter (C. coli/C. jejuni), Salmonella, Shiga toxin 1 (stx1), Shiga toxin 2 (stx2), Escherichia coli serotype O157 and Shigella.

The test is intended for use as an aid in the diagnosis of specific agents of gastrointestinal illness in conjunction with clinical and epidemiological information; however, it is not to be used to monitor these infections. Positive results do not rule out co-infection with other organisms and may not be the definitive cause of patient illness. Negative 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. Concomitant culture is necessary if organism recovery or further typing of bacterial agents is desired.

This in vitro diagnostic test is configured for use on Great Basin Analyser with Great Basin Stool Bacterial Pathogens Panel Cartridge Kit.

SPECIFICATIONS

AttributeValue
Analytical Sensitivity 

Campylobacter coli: 1.8 x 103 CFU/mL

Campylobacter jejuni: 1.3 x 103 CFU/mL

E. coli (stx1): 5.7 x 103 CFU/mL

E. coli (stx2): 4.4 x 103 CFU/mL

E. coli (stx1, stx2): 1.1 x 104 CFU/mL

E. coli (stx1, stx2 and O157): 1.6 x 104 CFU/mL

Salmonella bongori: 2.5 x 104 CFU/mL

Salmonella enterica: 1.9 x 104 CFU/mL

Shigella flexneri: 5.2 x 103 CFU/mL

Shigella sonnei: 1.4 x 104CFU/mL

Analytical Reactivity

Able to detect 100% of 91 strains representing organisms detected in Stool Bacterial Pathogens panel

Analytical Specificity

No cross-reactivity with 100 other non-target microorganisms tested

Reproducibility

Campylobacter coli/jejuni (99.3%)

Salmonella (98.83%)

Shiga toxin 1 (99.26%)

Shiga toxin 2 (98.56%)

E. coli serotype O157 (99.26%)

Shigella (99.93%)

Sample Type(s) Stool specimens preserved in either Cary Blair or C&S preservation transport media

WORKFLOW

FEATURES AND BENEFITS

Faster Clinical Decision Making and Improved Patient Outcomes

  • Simultaneous detection of prevalent foodborne pathogens directly from the patient’s preserved stool specimen
  • Easy-to-use sample-to-result solution delivers more diagnostic data per sample than low-plex technologies
  • Faster turnaround time (<2 hrs)
  • Actionable results: A right size syndromic panel focussed on the most common foodborne bacterial pathogens

Increased Lab Productivity

  • Highly automated
  • Freeing up laboratory’s valuable resources
  • Eliminating the need for stool culture

Increasing Laboratory Effectiveness

  • Targeted test for the relevant analytes
  • 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

 

ORDERING INFORMATION

ProductPack SizeItem Number
Great Basin Stool Bacterial Pathogens Panel 300780

References

  1. CDC: 2015 Final Pertussis Surveillance Report