Qualitative DNA/RNA test for 13 bacteria, 5 viruses, and 4 parasites - Vietnam Registration 2300794ĐKLH/BYT-HTTB

The BioFire® FilmArray® Gastrointestinal (GI) Panel is an in vitro diagnostic nucleic acid amplification test designed to be used with the BioFire® FilmArray® systems. The BioFire GI Panel can simultaneously detect and identify the nucleic acid from bacteria, viruses, and parasites directly from the stool sample in the Cary Blair transport medium taken from individuals with signs and/or symptoms of gastrointestinal infection. The following bacteria (including some enteropathogenic E. coli/Shigella groups), parasites, and viruses were identified by the BioFire GI Panel: • Campylobacter (C. jejuni/C. coli/C. upsaliensis) • Clostridium difficile (C. difficile) toxins A/B • Plesiomonas shigelloides • Salmonella • Vibrio (V. parahaemolyticus/V. vulnificus/ V. cholerae), including specific identification of Vibrio cholerae • Yersinia enterocolitica • Escherichia coli causing enterocolitis (EAEC) • Escherichia coli causing diarrhea (EPEC) • Escherichia coli causing enterotoxemia (ETEC) lt/st • Escherichia coli causing hemolysis (EHEC) stx1/stx2 (including specific identification of O157 E. coli in EHEC) • Shigella/Escherichia coli causing enterocolitis (EIEC) • Cryptosporidium • Cyclospora cayetanensis • Entamoeba histolytica • Giardia lamblia (also known as G. intestinalis and G. duodenalis) • Adenovirus F 40/41 • Astrovirus • Norovirus GI/GII • Rotavirus A • Sapovirus (Groups I, II, IV, and V) The BioFire GI Panel is intended as a tool to aid in the identification of specific pathogens causing gastrointestinal infections, and therefore the results should be considered in conjunction with other clinical, laboratory, and epidemiological findings. Positive results do not rule out the possibility of co-infection with uncharacterized organisms in the BioFire GI Panel. The identified organisms may not be the definitive cause of the infection. Concurrent culture is required to identify the organisms and to further characterize the bacterial pathogens. This device is not intended to monitor or guide the treatment of Clostridium difficile infections.