Description
Rapid molecular panel for detecting bacteria, viruses, and toxins that commonly cause acute diarrhea
The VERIGENE® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection. The test is performed on the automated VERIGENE System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and array hybridization to detect specific gastrointestinal microbial nucleic acid gene sequences associated with the following pathogenic bacteria and viruses: Campylobacter Group (composed of C. coli, C. jejuni, and C. lari), Salmonella species, Shigella species (including S. dysenteriae, S. boydii, S. sonnei, and S. flexneri), Vibrio Group (composed of V. cholerae and V. parahaemolyticus), Yersinia enterocolitica, Norovirus GI/GII, Rotavirus A.
In addition, EP detects the Shiga toxin 1 gene and Shiga toxin 2 gene virulence markers. Shiga toxin producing E. coli (STEC) typically harbor one or both genes that encode for Shiga toxins 1 and 2.
EP is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological information; however, is not to be used to monitor these infections. EP also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.
Due to the limited number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Yersinia enterocolitica, Vibrio Group and Shigella species were primarily established with contrived specimens.
Concomitant culture is necessary for organism recovery and further typing of bacterial agents.
EP results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative EP 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.
The VERIGENE® Enteric Pathogen (EP) Test is a rapid, easy-to-use, and cost-effective alternative to traditional stool diagnostics that delivers clinical, economic, and workflow benefits to hospitals and laboratories.
Clinical Benefits:
Therapeutic: Results can improve patient management decision making, thereby minimizing use of inappropriate or unnecessary drugs.
Accurate: Stool culture is less sensitive than molecular methods, with molecular testing detecting almost three times as many infections in the same set of samples.
Public Health: Results can trigger outbreak investigations.
Diagnostic: Results can mitigate further unnecessary downstream testing.
Psychologic: Results can lead to earlier peace of mind for the patient and physician once the causative pathogen has been identified.
Workflow Benefits:
Nearly 95% of all stool samples are negative, yet still require similar hands-on time by the technologist (1–2 hours) and incubation time (72–96 hours) per sample as a positive sample.
Confirmation of a negative stool sample takes only two hours on the VERIGENE® System, allowing laboratories to reallocate technologist time to other priorities within the lab.
Economic Benefits:
Lower cost from reduced use of inappropriate or unnecessary antimicrobial or antiviral drugs.
Potential reduction in length of stay and length of isolation for patients in the hospital.
Reduced cost of sample send-out to reference laboratories.
Reallocation of technician time.
Enteric Pathogens Test Specifications:
Bacteria:
Campylobacter Group
Salmonella spp.
Shigella spp.
Vibrio Group
Yersinia enterocolitica
Toxins:
Shiga Toxin 1 (stx1)
Shiga Toxin 2 (stx2)
Viruses:
Norovirus
Rotavirus
Features:
Automation: Sample-to-result
Instrumentation: VERIGENE® Reader and Processor SP
Workflow: On-demand and scalable
Sample Type: Stool preserved in cary-blair
Pipetting Steps: One
Hands-On Time: <5 minutes
Run Time: <2 hours
