Intended Use

The Film Array GI Panel is a multiplexed nucleic acid test capable of simultaneous qualitative detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples obtained from individuals with sign and/or symptoms of gastrointestinal infection.

Results are meant to be used in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule out co-infection with organisms not included in the
Film Array GI Panel.  The agent detected may not be the definite cause of the disease.

Reflex testing: Stools positive for Clostridium difficile with reflex to C. difficile Toxin A/B EIA test to help distinguish between active infection and colonization. Stool Culture is performed if Salmonella or Shigella is detected.