TABLE 3.
Performance of two gastrointestinal multiplex panels using characterized stool samples (n = 270)a
| Targetb | FilmArrayc |
Luminex |
FilmArrayd |
Luminex |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TN | TP | FP | FN | TN | TP | FP | FN | Sensitivity (% [95% CI]) | Specificity (% [95% CI]) | Sensitivity (% [95% CI]) | Specificity (% [95% CI]) | |
| Aeromonas spp. | 248 | 5 | 0 | 16 | 23.8 (10.2, 47.1) | 100 (98.2, 100) | ||||||
| Campylobacter spp. | 240 | 28 | 1 | 1 | 241 | 23 | 0 | 6 | 96.6 (81.4, 99.9) | 99.6 (97.4, 100) | 79.3 (61.3, 90.5) | 100 (98.1, 100) |
| Clostridium difficile | 229 | 33 | 5 | 3 | 229 | 33 | 4 | 3 | 91.7 (77.4, 97.9) | 97.9 (95.0, 99.2) | 91.7 (77.4, 97.9) | 98.3 (95.5, 99.5) |
| Plesiomonas shigelloidese | 265 | 2 | 0 | 0 | 100 (29, 100) | 100 (98.3, 100) | ||||||
| Salmonella spp. | 246 | 24 | 0 | 0 | 246 | 20 | 0 | 4 | 100 (83.7, 100) | 100 (98.1, 100) | 83.3 (63.5, 93.9) | 100 (98.1, 100) |
| Yersinia enterocolitica | 242 | 27 | 1 | 0 | 243 | 13 | 0 | 14 | 100 (85.2, 100) | 99.6 (97.5, 100) | 48.1 (30.7, 66) | 100 (98.1, 100) |
| Vibrio spp. | 270 | 0 | 0 | 0 | ND | ND | ||||||
| Vibrio cholerae | 270 | 0 | 0 | 0 | 270 | 0 | 0 | 0 | ND | ND | ND | ND |
| EAEC | 256 | 0 | 0 | 0 | ND | ND | ||||||
| EPEC | 243 | 0 | 0 | 0 | ND | ND | ||||||
| ETEC | 267 | 0 | 0 | 0 | 270 | 0 | 0 | 0 | ND | ND | ND | ND |
| STEC | 240 | 28 | 2 | 0 | 241 | 27 | 1 | 1 | 100 (85.7, 100) | 99.2 (96.8, 100) | 96.4 (80.8, 99.9) | 99.6 (97.5, 100) |
| E. coli 0157f | 258 | 11 | 0 | 0 | 257 | 10 | 1 | 1 | 100 (70, 100) | 100 (98.2, 100) | 90.9 (60.1, 99.9) | 99.6 (97.6, 100) |
| Shigella/EIEC | 258 | 10 | 1 | 1 | 259 | 9 | 0 | 2 | 90.9 (60.1, 99.9) | 99.6 (97.6, 100) | 81.8 (51.1, 96) | ND |
| Cryptosporidium spp. | 264 | 5 | 0 | 0 | 265 | 5 | 0 | 0 | 100 (51.1, 100) | 100 (98.3, 100) | 100 (51.1, 100) | 100 (98.3, 100) |
| Cyclospora cayetanensis | 269 | 0 | 0 | 0 | ND | ND | ||||||
| Entamoeba histolytica | 269 | 0 | 0 | 1 | 268 | 1 | 0 | 0 | 0 (0, 83.3) | 100 (98.3, 100) | 100 (16.8, 100) | 100 (98.3, 100) |
| Giardia lamblia | 263 | 7 | 0 | 0 | 263 | 7 | 0 | 0 | 100 (60, 100) | 100 (98.3, 100) | 100 (60, 100) | 100 (98.3, 100) |
| Adenovirus 40/41 | 258 | 9 | 2 | 1 | 259 | 8 | 0 | 2 | 90 (57.4, 99.9) | 99.2 (97.1, 100) | 80 (47.9, 95.4) | 100 (98.2, 100) |
| Norovirus GI/GII | 225 | 41 | 0 | 3 | 194 | 41 | 32 | 3 | 93.2 (81.3, 98.6) | 100 (98.0, 100) | 93.2 (81.3, 98.6) | 85.8 (80.7, 89.8) |
| Rotavirus | 255 | 14 | 1 | 0 | 254 | 13 | 1 | 1 | 100 (74.9, 100) | 99.6 (97.6, 100) | 92.9 (66.5, 99.9) | 99.6 (97.6, 100) |
| Sapovirus | 237 | 28 | 0 | 3 | 90.3 (74.3, 97.4) | 100 (98.1, 100) | ||||||
| Astrovirus | 257 | 11 | 0 | 0 | 100 (70, 100) | 100 (98.2, 100) | ||||||
The reference standard for a positive result was defined as an organism detected by (i) bacterial culture or microscopy or (ii) 2 methods.
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.
TP, true positive; TN, true negative; FP, false positive; FN, false negative.
CI, confidence interval; ND, not done.
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.
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.