TABLE 1

Methods of comparator testing and discrepancy analysis for all potential pathogens targeted by the FilmArray GI Panel

AnalyteComparator methodaDiscrepant analysisb
Campylobacter spp.CulturecadF and gyrA PCR, BTFA
C. difficiletcdA and tcdB PCRECP, BTFA
P. shigelloidesCulturehugA PCR, BTFA
Salmonella spp.Culturestn PCR
Vibrio spp.CulturegyrB PCR, BTFA
V. choleraeCulturegyrB PCR, BTFA
Y. enterocoliticaCultureNA
EAECaggR and aatA PCRECP, BTFA
EPECc2 × eae PCRECP, BTFA
ETECeltA, est1a, and est1b PCRECP, BTFA
STECstx1 and stx2 PCRECP, BTFA
E. coli O157dCulture (STEC positive only)rfbE PCR
Shigella spp./EIEC2 × ipaH PCRECP, BTFA
Shigella spp.CultureECP, BTFA
Cryptosporidium spp.DHFR and TRAPC1 PCRECP, 18S rRNA gene PCR, BTFA
C. cayetanensisITS2 and 18S rRNA gene PCRNA
E. histolytica18S rRNA gene and actin-like gene PCRNA
G. lamblia2 × 18S rRNA gene PCR (one published [18])ECP, BTFA
Adenovirus F 40/41hexon and pol PCRECP, BTFA
AstrovirusORF1a and ORF1b PCRECP, BTFA
Norovirus GI/GIIRdRp-capsid junction PCR (17)PCR with multiple primer sets, BTFA
RotavirusVP4 and VP7 PCRECP, BTFA
Sapovirus2 × RpRd-capsid junction PCR (one published [19])ECP, BTFA
  • a All PCR tests were followed by amplicon sequencing, except for the published assays for Giardia spp., norovirus GI/GII, and sapovirus. ORF, open reading frame.

  • b Benchtop FilmArray test; ECP, enhanced comparator protocol.

  • c If stx1 or stx2 was detected by the comparator STEC assay, the comparator EPEC results for the specimen were considered not applicable (NA). The same algorithm is utilized by the FilmArray GI Panel software.

  • d E. coli O157 comparator results were considered only if STEC was detected. The same algorithm is utilized by the FilmArray GI Panel software.