Despite advances in food safety, sanitation, and medical treatment, infectious gastroenteritis remains a significant problem in industrialized countries among all age groups. Globally, infectious diarrheal illness is a significant cause of mortality in young children resulting in an estimated 800,000 deaths per year in children under the age of 5. In addition to this significant morbidity and mortality, diarrhea in children contributes to malnutrition, increased susceptibility to other infections, and may lead to delays in growth and intellectual development. The FilmArray GI Panel simultaneously tests for 22 pathogens from stool specimens. Results from the FilmArray GI Panel test are available within about one hour.

This test is a qualitative test and does not provide a quantitative value for the organism(s) in the sample. 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. Results from this test must be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient. Due to high rates of asymptomatic carriage of Clostridium difficile, especially in very young children and hospitalized patients, the detection of toxigenic C. difficile should be interpreted within the context of guidelines developed by the testing facility or other experts (e.g., guidelines/policy statements published by The American Academy of Pediatrics or the Society for Healthcare Epidemiology of America and the Infectious Disease Society of America). The performance of this test has not been established for monitoring treatment of infection with any of the panel organisms.