Campylobacter, Salmonella, Vibrio, Yersinia enterocolitica, Shiga-Like Toxin-Producing E. coli (STEC), Shigella/Enteroinvasive E. coli (EIEC), Cryptosporidium, Cyclospora cayetanensis, Giardia lamblia, Norovirus

The FilmArray Gastrointestinal (GI) Panel Mid is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary-Blair transport media.

Feces: Collect in clean, dry bedpan or onto newspaper placed over toilet seat. Those portions of stool containing blood, pus or mucus are especially significant. Immediately place specimen in Cary Blair Transport Media (Para Pak C&S Orange); place at 2-8 C until transport to the lab. Sample must be placed in Cary-Blair within 2 hours of collection.

Patient Collection Instructions Handout

Sample must be placed in Cary Blair Transport Media (Para Pak C&S Orange) within 2 hours of collection. Preserved specimens must arrive in IDDL (performing laboratory) within 96 hours of collection. Store specimens at refrigerated temperature.

Ship specimens at refrigerated temperature. Must arrive within 96 hours.

Negative for all targets.

The presence of blood or mucus in the sample may interfere with testing.
Cary-Blair media used for dilution and processing of clinical stools, is screened by manufacturers for viable organisms but may not be specifically tested for microbial nucleic acids. The presence of nucleic acids at levels that can be detected by the FilmArray GI Panel Mid may lead to false positive test results.

Observed or Predicted Cross-Reactivity with Off-Panel Organisms

^a Cross-reactivity was not observed when tested at high concentration (1.5x10⁹ cells/mL). However, cross-reactivity was suspected or confirmed in clinical specimens and/or the potential for cross-reactivity is supported by in silico predictions.

^b Identified by investigation of suspected non-specific Noro 1 assay reactivity in clinical specimens. Cross-reactive sequences are inconsistent with other Prevotella sequence data, suggesting the non-specific interaction is with atypical Prevotella species and/or sequences.

^c Cross-reactivity resulting in false positive Salmonella results has not been observed in analytic or clinical testing. However, non-specific amplification products with Tm values close to the assay specific Tm range have been observed and the potential for false positive Salmonella test results exists.

^d Detected at concentrations near the Vibrio assay LoD.

^e Y. kristensenii and Y. fredericksenii are difficult to distinguish from Y. enterocolitica by standard laboratory methods.