TABLE 2.
Clinical performance compared with PIS by gender, sample type, and symptom statusa
| Sample type | Total (N) | % Prevalence (n/N) | % Sensitivity (n/N) | 95% CI | % Specificity (n/N) | 95% CI |
|---|---|---|---|---|---|---|
| Female participants | ||||||
| Urine | ||||||
| Symptomatic Asymptomatic Overall |
622 455 1,077 |
18.6 (116/622) 12.1 (55/455) 15.9 (171/1077) |
97.4 (113/116) 98.2 (54/55) 97.7 (167/171) |
92.7–99.1 90.4–99.7 94.1–99.1 |
98.8 (500/506) 98.5 (394/400) 98.7 (894/906) |
97.4–99.5 96.8–99.3 97.7–99.2 |
| Vaginal swab (both clinician- and self-collected) | ||||||
| Symptomatic Asymptomatic Overall |
623 454 1,077 |
18.6 (116/623) 12.1 (55/454) 15.9 (171/1077) |
100 (116/116) 98.2 (54/55) 99.4 (170/171) |
96.8–100 90.4–99.7 96.8–99.9 |
97.0 (492/507) 96.5 (385/399) 96.8 (877/906) |
95.2–98.2 94.2–97.9 95.4–97.8 |
| PreservCyt samples | ||||||
| Symptomatic Asymptomatic Overall |
622 452 1,074 |
18.5 (115/622) 12.2 (55/452) 15.8 (170/1074) |
93.9 (108/115) 96.4 (53/55) 94.7 (161/170) |
88.0–97.0 87.7–99.0 90.2–97.2 |
99.2 (503/507) 98.5 (391/397) 98.9 (894/904) |
98.0–99.7 96.7–99.3 98.0–99.4 |
| Endocervical swab | ||||||
| Symptomatic Asymptomatic Overall |
620 454 1,074 |
18.5 (115/620) 12.1 (55/454) 15.8 (170/1074) |
97.4 (112/115) 98.2 (54/55) 97.6 (116/170) |
92.6–99.1 90.4–99.7 94.1–99.1 |
98.8 (499/505) 97.2 (388/399) 98.1 (887/904) |
97.4–99.5 95.1–98.5 97.0–98.8 |
| All female subjectsb | ||||||
| Symptomatic Asymptomatic Overall |
625 455 1,080 |
18.6 (116/625) 12.1 (55/455) 15.8 (171/1080) |
||||
| Male participants | ||||||
| Urine | ||||||
| Symptomatic Asymptomatic Overall |
315 668 983 |
4.1 (13/315) 1.5 (10/668) 2.3 (23/983) |
100 (13/13) 100 (10/10) 100 (23/23) |
77.2–100 72.2–100 85.7–100 |
98.3 (297/302) 98.5 (648/658) 98.4 (945/960) |
96.2–99.3 97.2–99.2 97.4–99.1 |
| Meatal swab (both clinician- and self-collected) | ||||||
| Symptomatic Asymptomatic Overall |
315 662 977 |
4.1 (13/315) 1.7 (11/662) 2.5 (24/977) |
100 (13/13) 100 (11/11) 100 (24/24) |
77.2–100 74.1–100 86.2–100 |
91.1 (275/302) 93.2 (607/651) 92.5 (882/953) |
87.3–93.8 91.0–94.9 90.7–94.1 |
| All male subjectsb | ||||||
| Symptomatic Asymptomatic Overall |
315 668 983 |
4.1 (13/315) 1.5 (10/668) 2.3 (23/983) |
a
CI, confidence interval; N, total number of samples; n, number of T. vaginalis-positive samples (for prevalence), number of positive samples with accurate result (for sensitivity), or number of negative samples with accurate result (for specificity); PIS, patient infected status.
b
These numbers represent the overall prevalence of TV infection in male and female subjects.