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

Comparison, sample typeNo. of samples testedNo. of C. trachomatis PIS-positive samples tested/total no.% sensitivity (95% CI)P value for comparison with Cobas sensitivityNo. of C. trachomatis 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 women3,839254/27293.4 (89.8–95.8)0.3483,555/3,56799.7 (99.4–99.8)0.838
    Vaginal swab (clinician)3,836266/27098.5 (96.3–99.4)1.0003,531/3,56699.0 (98.6–99.3)0.882
CTQ/GCQ vs PIS (Cobas and AC2)
    Urine from women3,852243/28585.3 (80.7–88.9)<0.0013,560/3,56799.8 (99.6–99.9)0.480
    Vaginal swab (CC)3,825262/28392.6 (88.9–95.1)0.0063,536/3,54299.8 (99.6–99.9)<0.001
  • 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.