The GI Pathogen Profile, using the FilmArray multiplex PCR system, tests for 22 Viruses, parasites, and
bacteria, and offers new opportunities for the rapid, accurate diagnosis and prompt treatment of diarrheal
illnesses which may improve patient outcomes and clinical success.
While bacteria and parasites are the primary cause of food and water-borne diarrheal illness (48 million
infections/year), the vast majority of acute diarrheal illness is caused not by bacteria or parasites, but by
viral infections. In fact, Norovirus is the primary gastrointestinal infection occurring in the United States.
Even though testing for pathogenic bacteria and parasite is commonly available, there has been limited
availability of viral testing until recently.
Acute gastroenteritis may contribute to patient morbidity and even mortality, if the illness progresses to
severe dehydration. Also, the identification of reportable diseases is imperative to prevent large outbreaks,
especially for highly contagious or food-borne illnesses, and many gastrointestinal illnesses have very similar
Use the GI Pathogen Profile, multiplex PCR as a stand-alone test, or as a complement to our
Comprehensive Stool Analysis, to test for the presence of viral infections or to differentiate between
possible diarrheagenic strains of E. coli.
The GI Pathogen profile is performed using the FDA-cleared FilmArray multiplex PCR system. First, the
FilmArray extracts and purifies all nucleic acids from the unprocessed sample. Next, the FimArray performs
a nested multiplex PCR. During the first stage, the system performs a single, large volume, multiplexed
reaction. Finally, individual, singleplex second-stage PCR reactions detect the products from the first-stage
PCR. Using endpoint melting curve data, the FilmArray software automatically generates a result for
It should be noted that PCR testing is much more sensitive than traditional techniques and allows for the
detection of extremely low numbers of pathogens. This may cause the detection of clinically insignificant
of pathogens in healthy patients. PCR testing does not differentiate between viable and non-viable pathogens
and should not be repeated until 21 days after completion of treatment or resolution to prevent false
positives. PCR testing can detect multiple pathogens in the patient’s stool but does not differentiate the
causative pathogen. All decisions regarding the need for treatment should take the patient’s complete
clinical history and presentation into account.