TABLE 6.
Comparison, sample type | No. of samples tested | No. of N. gonorrhoeae PIS-positive samples tested/total no. | Sensitivity (95% CI) | P value for comparison with Cobas sensitivity | No. of N. gonorrhoeae PIS-negative samples tested/total no. | Specificity (95% CI) | P value for comparison with Cobas specificity |
---|---|---|---|---|---|---|---|
AC2 vs PIS (Cobas and CTQ/GCQ) | |||||||
Urine from women | 3,853 | 49/59 | 83.1 (71.5–90.5) | 0.012 | 3,778/3,794 | 99.6 (99.3–99.7) | 0.002 |
Vaginal swab (CC) | 3,830 | 56/58 | 96.6 (88.3–99.0) | 1.000 | 3,752/3,772 | 99.5 (99.2–99.7) | 0.203 |
CTQ/GCQ vs PIS (Cobas and AC2) | |||||||
Urine from women | 3,839 | 46/60 | 76.7 (64.6–85.6) | 0.001 | 3,778/3,779 | 100 (99.9–100) | 0.625 |
Vaginal swab (CC) | 3,839 | 56/60 | 93.3 (84.1–97.4) | 0.302 | 3,777/3,779 | 99.9 (99.8–100) | 0.046 |
AC2, Hologic APTIMA Combo 2 CT/NG Assay; CC, clinician collected; Cobas, Cobas CT/NG test for use on the Cobas 6800/8800 systems; CTQ/GCQ, BD ProbeTec CT Qx and GC Qx amplified DNA assays; NAAT, nucleic acid amplification test; PIS, patient infected status.