Table 2.
Studies included in the clinical validation
| Study | No. at CHMI | CHMI route | No. TBS+ | No. biomarker+ | No. treated for infection |
|---|---|---|---|---|---|
| MC-001 | 6 | 5 bites | 6 | 6 | 6 |
| MC-003* | 29 | 5 bites | 26* | 25 | 26* |
| PfSPZ-CVac PYR | 21 | 3200 DVI | 6 | 15 | 15 |
CHMI = controlled human malaria infection; DVI = direct venous injection; PYR = pyrimethamine; TBS = thick blood smear.
* One MC-003 participant was treated on the basis of a mislabeled blood smear specimen and was excluded from this analysis as described in the text. The analysis herein includes n = 28 participants, including 25 who were blood smear–positive and 18S rRNA biomarker positive.