TABLE 3.
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 type | No. of samples tested | No. of C. trachomatis PIS-positive samples tested/total no. | % sensitivity (95% CI) | P value for comparison with Cobas sensitivity | No. 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 women | 3,839 | 254/272 | 93.4 (89.8–95.8) | 0.348 | 3,555/3,567 | 99.7 (99.4–99.8) | 0.838 |
| Vaginal swab (clinician) | 3,836 | 266/270 | 98.5 (96.3–99.4) | 1.000 | 3,531/3,566 | 99.0 (98.6–99.3) | 0.882 |
| CTQ/GCQ vs PIS (Cobas and AC2) | |||||||
| Urine from women | 3,852 | 243/285 | 85.3 (80.7–88.9) | <0.001 | 3,560/3,567 | 99.8 (99.6–99.9) | 0.480 |
| Vaginal swab (CC) | 3,825 | 262/283 | 92.6 (88.9–95.1) | 0.006 | 3,536/3,542 | 99.8 (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.