Comparison of GeneXpert TV assay results in symptomatic and asymptomatic women compared with a patient-infected status of culture and/or a NAAT assay
| Sample type | Status | Total (n) | Sens | Spec | Prev (%) | PPV (%) | NPV (%) |
| ES | Symp | 685 | 100% (71/71) | 98.5% (605/614) | 10.4 | 88.8 | 100 |
| Asymp | 1114 | 98.1% (104/106) | 99.1% (999/1008) | 9.5 | 92.0 | 99.8 | |
| Overall | 1799 | 98.9% (175/177)* | 98.9% (1604/1622)† | 9.8 | 90.7 | 99.9 | |
| Difference | p Value | p=0.517 | p=0.331 | ||||
| PC-VS | Symp | 682 | 98.6% (73/74) | 99.5% (605/608) | 10.9 | 96.1 | 99.8 |
| Asymp | 1109 | 95.0% (113/119) | 99.6% (986/990) | 10.7 | 96.6 | 99.4 | |
| Overall | 1791 | 96.4% (186/193)‡ | 99.6% (1591/1598)§ | 10.8 | 96.4 | 99.6 | |
| Difference | p Value | p=0.254 | p=1.000 | ||||
| UR | Symp | 688 | 98.6% (71/72) | 99.8% (615/616) | 10.5 | 98.6 | 99.8 |
| Asymp | 1105 | 98.2% (109/111) | 99.6% (990/994) | 10.0 | 96.5 | 99.8 | |
| Overall | 1793 | 98.4% (180/183)¶ | 99.7% (1605/1610)** | 10.2 | 97.3 | 99.8 | |
| Difference | p Value | p=1.000 | p=0.655 | ||||
*Testing results by sequencing: 1 of 2 FN was TV positive; 1 of 2 was TV negative.
†Testing results by sequencing: 8 of 18 FP were TV positive; 10 of 18 were TV negative.
‡Testing results by sequencing: 3 of 7 FN were TV positive; 4 of 7 were TV negative.
§Testing results by sequencing: 5 of 7 FP were TV positive; 2 of 7 were TV negative.
¶Testing results by sequencing: 3 of 3 FN were TV negative.
**Testing results by sequencing: 5 of 5 FP were TV negative.
ES, endocervical swab; NAAT, nucleic acid amplification test; PC-VS, patient-collected vaginal swab; UR, urine.