Table 2.
Number of Positive Test Results for Clostridioides (Clostridium) difficile at Screening From Central Laboratory ELISA Versus BioFire (mFAS)
| Patient group | ELISA Result | BioFire Result | |||
|---|---|---|---|---|---|
| Positive | Negative | Missing | Total | ||
| All patients | Positive | 225 | 4 | 1 | 230 |
| Negative | 61 | 36 | 2 | 99 | |
| Missing | 1 | 0 | 26 | 27 | |
| Total | 287 | 40 | 29 | 356 | |
| EPFX | Positive | 112 | 3 | 1 | 116 |
| Negative | 29 | 20 | 0 | 49 | |
| Missing | 1 | 0 | 11 | 12 | |
| Total | 142 | 23 | 12 | 177 | |
| Vancomycin | Positive | 113 | 1 | 0 | 114 |
| Negative | 32 | 16 | 2 | 50 | |
| Missing | 0 | 0 | 15 | 15 | |
| Total | 145 | 17 | 17 | 179 |
Abbreviations: ELISA, enzyme-linked immunosorbent assay; EPFX, extended-pulsed fidaxomicin; mFAS, modified full analysis set (all randomized patients with positive local laboratory test for C difficile toxin A/B at screening, who received at least 1 dose of study medication).