TABLE 6

Rotating PIS analysis of sensitivity and specificity of NAATs for detecting Neisseria gonorrhoeae in urine and clinician-collected vaginal swab samples from womena

Comparison, sample typeNo. of samples testedNo. of N. gonorrhoeae PIS-positive samples tested/total no.Sensitivity (95% CI)P value for comparison with Cobas sensitivityNo. 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 women3,85349/5983.1 (71.5–90.5)0.0123,778/3,79499.6 (99.3–99.7)0.002
    Vaginal swab (CC)3,83056/5896.6 (88.3–99.0)1.0003,752/3,77299.5 (99.2–99.7)0.203
CTQ/GCQ vs PIS (Cobas and AC2)
    Urine from women3,83946/6076.7 (64.6–85.6)0.0013,778/3,779100 (99.9–100)0.625
    Vaginal swab (CC)3,83956/6093.3 (84.1–97.4)0.3023,777/3,77999.9 (99.8–100)0.046
  • a 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.