Table 10.
Results generated comparing the assay to an alternative commercially available test and PCR and sequencing with other nucleic acid amplification techniques (NAAT).
| Target | Specimen Type | Samples Tested | EP005 Positive | Confirmatory Method | Positive with Confirmatory Method |
|---|---|---|---|---|---|
| Cryptosporidium spp. | Prospective | 380 | 10 | BD MAX™ | 9 |
| G. intestinalis | Prospective | 380 | 20 | BD MAX™ | 21 |
| E. histolytica | Prospective | 380 | 8 | BD MAX™ | 8 |
| B. hominis | Prospective | 380 | 24 | NAAT | 11/16 * |
| D. fragilis | Prospective | 380 | 37 | NAAT | 15/16 * |
| C. cayetanensis | Retrospective | 11 | 11 | NAAT | 11 |
| E. bieneusi | Retrospective | 21 | 21 | NAAT | 19 ** |
| E. intestinalis | Contrived/Retrospective | 5 | 5 | NAAT | 5 |
* 16 samples of each were selected for sequencing with five B. hominis and one D. fragilis samples negative by NAAT due to the improved sensitivity of the 3base™ assay. ** 2 samples were negative by NAAT due to the improved sensitivity of the 3base™ assay.