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Gastrointestinal disease can be caused by many agents, including bacteria, viruses and parasites. Culture for bacteria will not pick up the viruses or parasites. Tests for parasites will not detect the viruses or the bacteria. This GI profile is a multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of nucleic acids from multiple bacteria, viruses and parasites directly from stool samples in Cary-Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection.
The performance of this test has not been established for patients without signs and symptoms of gastrointestinal illness. Virus, bacteria and parasite nucleic acid may persist in vivo independently of organism viability. Additionally, some organisms may be carried asymptomatically. Detection of organism targets does not imply that the corresponding organisms are infectious or are the causative agents for clinical symptoms. The detection of organism nucleic acid is dependent upon proper sample collection, handling, transportation, storage and preparation. Failure to observe proper procedures in any one of these steps can lead to incorrect results. There is a risk of false-positive and false-negative results caused by improperly collected, transported or and handled specimens.
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FilmArray Gastrointestinal Panel (GI) Instruction Booklet (RFIT-PRT-0143-01), BioFire Diagnostics, LLC.
Rand KH, Tremblay EE, Hoidal M, et al. Multiplex gastrointestinal pathogens panels: implications for infection control. Diagn Microbiol Infect Dis. 2015 Jun;82(2):154-157. PubMed 25796558
Riddle MS, DuPont HL, Connor BA. ACG Clinical Guidelines: Diagnosis, Treatment and Prevention of Acute Diarrheal Infections in Adults. Am J Gastroenterol. 2016 May;111(5):602-622. PubMed 27068718
Safety Data Sheet (SDS/MSDS) FilmArray™ Reagent Kit.
Spina A, Kerr KG, Cormican M, et al. Spectrum of enteropathogens detected by FilmArray® GI Panel in a multicentre study of community-acquired gastroenteritis. Clin Microbiol Infect. 2015 Aug;21(8):719-728. PubMed 25908431
