VERIGENE® EP 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.
|Shiga Toxin 1 (stx1)||•||•|
|Shiga Toxin 2 (stx2)||•||•|
|Automation||Sample to Result|
|Instrumentation||VERIGENE Reader and Processor SP|
|Workflow||On-Demand and Scalable|
|Sample Type||Stool Preserved in Cary-Blair|
|Hands-On Time||<5 minutes|
|Run Time||<2 hours|
|Conventional Stool vs VERIGENE Enteric Pathogens (EP) Test Workflow Comparison|
|Practice Guidelines for the Management of Infectious Diarrhea|
|Evaluation of the VERIGENE Enteric Pathogens (EP) Nucleic Acid Test for the Identification of Bacterial and Viral Agents of Diarrhea Directly from Stool Specimens|
|A Comparison of Three Multiplex Molecular Panels for the Detection of Gastrointestinal Pathogens|
|Fecal Matters: Clinical Impact and Cost Effectiveness of Molecular GI Pathogen Testing|
|Molecular Testing for GI Pathogens: Cost-Effectiveness, Clinical Impact and Lab Implementation|
|Justification, Validation and Implementation Best Practices for Multiplex Molecular Infectious Disease Tests|
The VERIGENE® System requires less than five minutes of user hands-on time and delivers comprehensive results directly from a stool sample in less than two hours for diagnosis in gastrointestinal infections.
For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.
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.