TABLE 3.
Overall investigational-assay performance
| Target | Prevalence (%) | Specimen type (n) | Sensitivity |
Specificity |
||
|---|---|---|---|---|---|---|
| No./total | % (95% CI) | No./total | % (95% CI) | |||
| BV | 49.2 | Clinician collected (1,413) | 660/695a | 95.0 (93.1–96.4) | 643/718b | 89.6 (87.1–91.6) |
| 49.3 | Patient collected (1,405) | 673/692c | 97.3 (95.8–98.2) | 612/713d | 85.8 (83.1–88.2) | |
| Candida sp. group | 28.6 | Clinician collected (1,485) | 389/424 | 91.7 (88.7–94.0) | 1,007/1,061 | 94.9 (93.4–96.1) |
| 28.6 | Patient collected (1,477) | 392/422 | 92.9 (90.0–95.0) | 960/1,055 | 91.0 (89.1–92.6) | |
| C. glabrata | 4.0 | Clinician collected (1,483) | 50/59e | 84.7 (73.5–91.8) | 1,411/1,424f | 99.1 (98.4–99.5) |
| 3.9 | Patient collected (1,475) | 50/58g | 86.2 (75.1–92.8) | 1,399/1,417h | 98.7 (98.0–99.2) | |
| T. vaginalis | 9.9 | Clinician collected (1,438) | 137/142i | 96.5 (92.0–98.5) | 1,233/1,296j | 95.1 (93.8–96.2) |
| 9.8 | Patient collected (1,433) | 136/140k | 97.1 (92.9–98.9) | 1,279/1,293l | 98.9 (98.2–99.4) | |
Of the 35 subjects with false-negative results, 10 subjects were Nugent intermediates and had BV infection status determined by modified Amsel criteria, and 15 were negative by modified Amsel criteria.
Of the 75 subjects with false-positive results, 46 subjects were Nugent intermediates and had BV infection status determined by modified Amsel criteria, and 6 were positive by modified Amsel criteria.
Of the 19 subjects with false-negative results, 6 subjects were Nugent intermediates and had BV infection status determined by modified Amsel criteria, and 7 were negative by modified Amsel criteria.
Of the 101 subjects with false-positive results, 55 subjects were Nugent intermediates and had BV infection status determined by modified Amsel criteria, and 9 were positive by modified Amsel criteria.
All 9 samples with false-negative results showed no growth of C. glabrata on chromogenic agar.
Of the 13 samples with false-positive results, 2 showed high (4+) growth, 2 showed low (≤2+) growth, and 9 showed no growth of C. glabrata on chromogenic agar.
Of the 8 samples with false-negative results, 7 showed no growth and 1 showed high (4+) growth of C. glabrata on chromogenic agar.
Of the 18 samples with false-positive results, 2 showed high (4+) growth, 2 showed low (≤2+) growth, and 14 showed no growth of C. glabrata on chromogenic agar.
Of the 5 samples with false-negative results, 3 were confirmed negative with the Aptima Trichomonas vaginalis assay.
Of the 63 samples with false-positive results, 56 were confirmed positive with the Aptima Trichomonas vaginalis assay.
Of the 4 samples with false-negative results, 3 were confirmed negative with the Aptima Trichomonas vaginalis assay.
Of the 14 samples with false-positive results, 8 were confirmed positive with the Aptima Trichomonas vaginalis assay.