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.
View our webinar titled “Molecular GI Testing – An Approach Based on Clinical Guidelines.” This program discusses the new guidelines for the diagnosis of infectious diarrhea and how multiplexed molecular GI testing can have a positive impact on patient care. Additionally, the speakers shared best practices for implementing the VERIGENE® Enteric Pathogens Test (EP), to ensure their laboratories recognized these clinical, operational, and economic benefits. Click here for the program summary
|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|
|Luminex Online Order Management|
|Phone:||+31 (0)73 800 1900|
|Fax:||+31 (0)73 800 1998|
|Product Name||Kit Size||Registration
|VERIGENE® Enteric Pathogens Nucleic Acid Test (EP) Kit||20 EP Test Cartridges
20 Extraction Trays
|VERIGENE® Enteric Pathogens Nucleic Acid Test (EP) Amplification Kit||20 EP Amplification Trays||US-IVD
|VERIGENE® Sample Processor SP||1 unit||US-IVD
|VERIGENE® Reader||1 unit||US-IVD
VERIGENE® Enteric Pathogens Nucleic Acid Test (EP) – Product Information
Practice Guidelines for the Management of Infectious Diarrhea – IDSA Guidelines
Clinical labs need flexibility and scalability in their GI assays to deliver optimal results to physicians. Luminex offers targeted diagnostic options for nosocomial diarrhea and syndromic panels for community acquired/traveler’s diarrhea that align with recommended guidelines.
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.