Clinical performance for Neisseria gonorrhoeae detection by sample type and symptom status compared with patient infection status
| Sample type and symptom status | Total (n) | SENS | 95% CI | SPEC | 95% CI | PREV (%) | PPV (%) | NPV (%) |
| Female endocervical swab | ||||||||
| Symp | 1930 | 95.2% (40/42) | 84.2 to 98.7 | 99.9% (1886/1888) | 99.6 to 100.0 | 2.2 | 95.2 | 99.9 |
| Asymp | 3174 | 97.9% (46/47) | 88.9 to 99.6 | 99.9% (3124/3127) | 99.7 to 100.0 | 1.5 | 93.9 | 100.0 |
| Overall | 5104 | 96.6% (86/89) | 90.6 to 98.8 | 99.9% (5010/5015) | 99.8 to 100.0 | 1.7 | 94.5 | 99.9 |
| Female urine | ||||||||
| Symp | 1937 | 90.5% (38/42) | 77.9 to 96.2 | 99.7% (1890/1895) | 99.4 to 99.9 | 2.2 | 88.4 | 99.8 |
| Asymp | 3190 | 100.0% (48/48) | 92.6 to 100.0 | 99.6% (3130/3142) | 99.3 to 99.8 | 1.5 | 80.0 | 100.0 |
| Overall | 5127 | 95.6% (86/90) | 89.1 to 98.3 | 99.7% (5020/5037) | 99.5 to 99.8 | 1.8 | 83.5 | 99.9 |
| Female clinician-collected vaginal swab | ||||||||
| Symp | 898 | 100.0% (21/21) | 84.5 to 100.0 | 99.7% (874/877) | 99.0 to 99.9 | 2.3 | 87.5 | 100.0 |
| Asymp | 2240 | 100.0% (37/37) | 90.6 to 100.0 | 99.7% (2197/2203) | 99.4 to 99.9 | 1.7 | 86.0 | 100.0 |
| Overall | 3138 | 100.0% (58/58) | 93.8 to 100.0 | 99.7% (3071/3080) | 99.4 to 99.8 | 1.8 | 86.6 | 100.0 |
| Female self-collected vaginal swab | ||||||||
| Symp | 1041 | 95.2% (20/21) | 77.3 to 99.2 | 100.0% (1020/1020) | 99.6 to 100.0 | 2.0 | 100.0 | 99.9 |
| Asymp | 996 | 100.0% (9/9) | 70.1 to 100.0 | 100.0% (987/987) | 99.6 to 100.0 | 0.9 | 100.0 | 100.0 |
| Overall | 2037 | 96.7% (29/30) | 83.3 to 99.4 | 100.0% (2007/2007) | 99.8 to 100.0 | 1.5 | 100.0 | 100.0 |
| Female PreservCyt (pre aliquot) | ||||||||
| Symp | 1935 | 100.0% (43/43) | 91.8 to 100.0 | 99.9% (1890/1892) | 99.6 to 100.0 | 2.2 | 95.6 | 100.0 |
| Asymp | 3196 | 93.9% (46/49) | 83.5 to 97.9 | 99.8% (3142/3147) | 99.6 to 99.9 | 1.5 | 90.2 | 99.9 |
| Overall | 5131 | 96.7% (89/92) | 90.8 to 98.9 | 99.9% (5032/5039) | 99.7 to 99.9 | 1.8 | 92.7 | 99.9 |
| Female PreservCyt (post aliquot) | ||||||||
| Symp | 1872 | 95.3% (41/43) | 84.5 to 98.7 | 99.8% (1825/1829) | 99.4 to 99.9 | 2.3 | 91.1 | 99.9 |
| Asymp | 2996 | 95.8% (46/48) | 86.0 to 98.8 | 99.7% (2940/2948) | 99.5 to 99.9 | 1.6 | 85.2 | 99.9 |
| Overall | 4868 | 95.6% (87/91) | 89.2 to 98.3 | 99.7% (4765/4777) | 99.6 to 99.9 | 1.9 | 87.9 | 99.9 |
| Male urine | ||||||||
| Symp | 278 | 100.0% (60/60) | 94.0 to 100.0 | 99.1% (216/218) | 96.7 to 99.7 | 21.6 | 96.8 | 100.0 |
| Asymp | 460 | 100.0% (7/7) | 64.6 to 100.0 | 99.3% (450/453) | 98.1 to 99.8 | 1.5 | 70.0 | 100.0 |
| Overall | 738 | 100.0% (67/67) | 94.6 to 100.0 | 99.3% (666/671) | 98.3 to 99.7 | 9.1 | 93.1 | 100.0 |
| All combined | 26 143 | 97.1% (502/517) | 95.3 to 98.2 | 99.8% (25 571/25 626) | 99.7 to 99.8 | 2.0 | 90.1 | 99.9 |
Participants are designated as being infected with Neisseria gonorrhoeae if at least two predicate nucleic acid amplification tests with different target regions give positive results in the endocervical swab (urethral swab for men) and/or the urine specimen. However, women are categorised as uninfected for any swab specimen if the swab specimens and the PreservCyt (Gen-Probe Aptima Combo2 Assay for CT and NG) specimen were negative and the urine specimens were positive. Participants with designated infection status and valid cobas CT/NG v2.0 test results are considered evaluable and included in this summary table.
Asymp, asymptomatic; CT, Chlamydia trachomatis; NG, Neisseria gonorrhoeae; NPV, negative predictive value; PPV, positive predictive value; PREV, prevalence; SENS, sensitivity; SPEC, specificity; Symp, symptomatic.