Neisseria gonorrhoeae (NG) detection performance characteristics for the Roche cobas 4800 CT/NG test compared with opa/pap in-house PCR confirmatory testing
| Urogenital* | Rectal† | Oropharyngeal‡ | |
|---|---|---|---|
| % Sensitivity | 100 (86.9–99.9) | 100 (87.8–99.9) | 100 (90.5–99.9) |
| % Specificity | 99.9 (99.4–100) | 99.8 (98.8–100) | 99.7 (99.3–99.9) |
| % PPV | 96.0 (81.5–99.5) | 96.4 (82.7–99.5) | 88.6 (76.0–95.2) |
| % NPV | 100 (99.6–100) | 100 (99.2–100) | 100 (99.8–100) |
‘True positive’=patient sample, from specified site, NG detected in cobas 4800 CT/NG test and opa/pap in-house test (opa and/or pap gene target detected).
‘False positive’=patient sample, from specified site, NG detected in cobas 4800 CT/NG test but not in the opa/pap in-house test (neither opa nor pap gene target detected).
‘True negative’=NG not detected by cobas 4800 CT/NG test.
‘False negative’=NG not detected by cobas 4800 CT/NG test but detected using the opa/pap gene targets.
Wilson Confidence Intervals are shown in the table in parentheses.
*1832 patients (49/51 patients confirmed positive).
†961 patients (53/55 patients confirmed positive).
‡3242 patients (70/79 patients confirmed positive).
NPV, negative predictive value; PPV, positive predictive value.