TABLE 3

Performance of two gastrointestinal multiplex panels using characterized stool samples (n = 270)a

TargetbFilmArraycLuminexFilmArraydLuminex
TNTPFPFNTNTPFPFNSensitivity (% [95% CI])Specificity (% [95% CI])Sensitivity (% [95% CI])Specificity (% [95% CI])
Aeromonas spp.248501623.8 (10.2, 47.1)100 (98.2, 100)
Campylobacter spp.2402811241230696.6 (81.4, 99.9)99.6 (97.4, 100)79.3 (61.3, 90.5)100 (98.1, 100)
Clostridium difficile2293353229334391.7 (77.4, 97.9)97.9 (95.0, 99.2)91.7 (77.4, 97.9)98.3 (95.5, 99.5)
Plesiomonas shigelloidese265200100 (29, 100)100 (98.3, 100)
Salmonella spp.24624002462004100 (83.7, 100)100 (98.1, 100)83.3 (63.5, 93.9)100 (98.1, 100)
Yersinia enterocolitica242271024313014100 (85.2, 100)99.6 (97.5, 100)48.1 (30.7, 66)100 (98.1, 100)
Vibrio spp.270000NDND
Vibrio cholerae270000270000NDNDNDND
EAEC256000NDND
EPEC243000NDND
ETEC267000270000NDNDNDND
STEC24028202412711100 (85.7, 100)99.2 (96.8, 100)96.4 (80.8, 99.9)99.6 (97.5, 100)
E. coli 0157f25811002571011100 (70, 100)100 (98.2, 100)90.9 (60.1, 99.9)99.6 (97.6, 100)
Shigella/EIEC258101125990290.9 (60.1, 99.9)99.6 (97.6, 100)81.8 (51.1, 96)ND
Cryptosporidium spp.264500265500100 (51.1, 100)100 (98.3, 100)100 (51.1, 100)100 (98.3, 100)
Cyclospora cayetanensis269000NDND
Entamoeba histolytica2690012681000 (0, 83.3)100 (98.3, 100)100 (16.8, 100)100 (98.3, 100)
Giardia lamblia263700263700100 (60, 100)100 (98.3, 100)100 (60, 100)100 (98.3, 100)
Adenovirus 40/4125892125980290 (57.4, 99.9)99.2 (97.1, 100)80 (47.9, 95.4)100 (98.2, 100)
Norovirus GI/GII22541031944132393.2 (81.3, 98.6)100 (98.0, 100)93.2 (81.3, 98.6)85.8 (80.7, 89.8)
Rotavirus25514102541311100 (74.9, 100)99.6 (97.6, 100)92.9 (66.5, 99.9)99.6 (97.6, 100)
Sapovirus237280390.3 (74.3, 97.4)100 (98.1, 100)
Astrovirus2571100100 (70, 100)100 (98.2, 100)
  • a The reference standard for a positive result was defined as an organism detected by (i) bacterial culture or microscopy or (ii) 2 methods.

  • b EAEC, enteroaggregative E. coli; EPEC, enteropathogenic E. coli; ETEC, enterotoxigenic E. coli (lt/st); STEC, Shiga-like toxin-producing E. coli (stx1/stx2; E. coli 0157); EIEC, enteroinvasive E. coli; empty cells, not present on the panel.

  • c TP, true positive; TN, true negative; FP, false positive; FN, false negative.

  • d CI, confidence interval; ND, not done.

  • e FilmArray yielded additional detections for P. shigelloides (n = 3), EAEC (n = 14), EPEC (n = 27), ETEC (n = 3), E. coli O157 (n = 1), Aeromonas (n = 1), Cryptosporidium (n = 1), Cyclospora (n = 1), norovirus (n = 1), sapovirus (n = 2), and astrovirus (n = 2) that could not be confirmed due to lack of a confirmatory method or insufficient remaining sample volume. These samples were not included in the calculation of performance characteristics.

  • f Luminex yielded additional detections for E. coli O157 (n = 1), E. histolytica (n = 1), C. difficile (n = 1), adenovirus (n = 1), and rotavirus (n = 1) that could not be confirmed due to lack of a confirmatory method or insufficient remaining sample volume. These samples were not included in the calculation of performance characteristics.