TABLE 3.
Female Chlamydia trachomatis and Neisseria gonorrhoeae Rotating Patient Infection Status* (Nucleic Acid Amplification Test From Endocervical/Urine Specimens)
| Chlamydia trachomatis; % [95% CI] (n/N)†,‡ | Neisseria gonorrhoeae; % [95% CI] (n/N)§,¶ | |||
|---|---|---|---|---|
| Sensitivity | Specificity | Sensitivity | Specificity | |
| Vaginal specimens | ||||
| AC2-clinician∥ | 96.2 [91.4–98.4] (126/131) | 98.8 [98.3–99.2] (2353/2382) | 100 [91.8–100] (43/43) | 99.8 [99.6–99.9] (2468/2472) |
| CT/GC Viper-Self** | 96.2 [91.3–98.7] (125/130) | 99.3 [98.6–99.6] (2,370/2,387) | 100 [91.6–100] (42/42) | 99.4 [99.0–99.7] (2,460/2,475) |
| CTGCTV2-clinician | 98.4 [94.5–99.6] (126/128) | 98.9 [98.4–99.3] (2,348/2,374) | 97.7 [87.9–99.6] (42/43) | 99.9 [99.6–100] (2,457/2,460) |
| CTGCTV2-self | 98.4 [94.5–99.6] (126/128) | 98.7 [98.1–99] (2,348/2,380) | 100 [91.8–100] (43/43) | 99.8 [99.6–99.9] (2,459/2,463) |
| Urine specimens | ||||
| AC2∥ | 85.6 [78.8–90.5] (119/139) | 99.8 [99.6–99.9] (2288/2292) | 88.1 [75.0–94.8] (37/42) | 100 [99.8–100] (2390/2391) |
| CT/GC Viper** | 88.5 [82.1–92.8] (123/139) | 99.6 [99.3–99.8] (2267/2275) | 97.6 [87.7–99.6] (41/42) | 99.8 [99.5–99.9] (2368/2373) |
| CT/NG Xpert†† | 92.2 [86.2–95.7] (118/128) | 99.8 [99.4–99.9] (1439/1442) | 95.1 [83.9–98.7] (39/41) | 100 [99.7–100] (1529/1529) |
| CTGCTV2 | 92.6 [86.9–95.9] (125/135) | 99.4 [99.0–99.6] (2314/2328) | 95.3 [84.5–98.7] (41/43) | 100 [99.8–100.0] (2419/2419) |
*Rotating PIS positive definition: At least 2 reference CT or GC NAATs results are positive, with at least 1 positive from each assay and at least 1 endocervical or LBC result positive for swab specimens.
†Statistical comparison by Fisher exact test revealed no significant difference in CT sensitivity or specificity values (P = 0.4967 and P = 0.1545, respectively) on vaginal specimens for the following tests: AC2, CT/GC Viper, CTGCTV2, and CTGCTV2 groups.
‡Statistical comparison by Fisher exact test revealed no significant difference in CT sensitivity or specificity values (P = 0.2048 and P = 0.0854, respectively) on urine specimens for the following tests: AC2, CT/GC Viper, CTGCTV2, and CTGCTV2 groups.
§Statistical comparison by Fisher exact test revealed no significant difference in GC sensitivity, but a significant difference between at least 2 groups for specificity values (P = 1.0000 and P = 0.0061, respectively) on vaginal specimens for the following tests: AC2, CT/GC Viper, CTGCTV2, and CTGCTV2 groups.
¶Statistical comparison by Fisher exact test revealed no significant difference in GC sensitivity, but a significant difference between at least 2 groups for specificity values (P = 0.3663 and P = 0.0259, respectively) on urine specimens for the following tests: AC2, CT/GC Viper, CTGCTV2, and CTGCTV2 groups.
∥Compared against references assays: CT/GC Viper Endocervical Swab and Urine, BD CTGCTV2 Endocervical Swab and Urine.
**Compared against references assays: AC2 LBC and Urine, BD CTGCTV2 Endocervical Swab and Urine.
††Compared against references assays: AC2 LBC and Urine, CT/GC Viper Endocervical Swab and Urine.
AC2 indicates Aptima Combo 2; CTGCTV2, BD CTGCTV2 assay for BD MAX; CT/GC Viper, BD ProbeTec CTQx and GCQx Viper; CT/NG Xpert, GeneXpert CT/NG.