TABLE 2.
Single- and multiple-infection rates determined by clinical reference method and investigational NAAT
| Infectiona | Result [no. (%)]b
|
||
|---|---|---|---|
| Reference method (n = 1,365) | Investigational NAAT |
||
| Clinician collected (n = 1,491) | Patient collected (n = 1,480) | ||
| All negative | 425 (31.1) | 430 (28.8) | 399 (27.0) |
| BV, Candida spp., C. glabrata, T. vaginalis | 3 (0.2) | 2 (0.1) | 4 (0.3) |
| BV only | 435 (31.9) | 427 (28.6) | 456 (30.8) |
| BV, Candida spp. | 135 (9.9) | 166 (11.1) | 202 (13.6) |
| BV, C. glabrata | 4 (0.3) | 7 (0.5) | 12 (0.8) |
| BV, T. vaginalis | 71 (5.2) | 108 (7.2) | 80 (5.4) |
| BV, Candida spp., C. glabrata | 8 (0.6) | 8 (0.5) | 8 (0.5) |
| BV, Candida spp., T. vaginalis | 19 (1.4) | 25 (1.7) | 29 (2.0) |
| BV, C. glabrata, T. vaginalis | 1 (0.1) | 2 (0.1) | 1 (0.1) |
| Candida spp. only | 190 (13.9) | 212 (14.2) | 212 (14.3) |
| Candida spp., C. glabrata | 22 (1.6) | 13 (0.9) | 15 (1.0) |
| Candida spp., T. vaginalis | 12 (0.9) | 15 (1.0) | 16 (1.1) |
| Candida spp., C. glabrata, T. vaginalis | 3 (0.2) | 2 (0.1) | 1 (0.1) |
| C. glabrata only | 12 (0.9) | 28 (1.9) | 27 (1.8) |
| C. glabrata, T. vaginalis | 0 (0.0) | 1 (0.1) | 0 (0.0) |
| T. vaginalis only | 25 (1.8) | 45 (3.0) | 18 (1.2) |
a
Candida spp., Candida species group.
b
The summary in each column includes only subjects with valid conclusive results for all four analytes.