Table 3.
The clinical performance (sensitivity, specificity, PPV and NPV) with 95% confidence intervals of the triage tests/methods for detection of CIN2 or CIN2+ among HPV DNA positives by sampling method (clinician or self) and test (careHPV™ or HC2)
| careHPV+ (clinician) | HC2+ (clinician) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| HPV16/18/45 | HPV16/18/45 | |||||||||
| careHPV (≥10) | DNA | E6 | Colpo Impression | VIA (2nd) | HC2 (≥10) | E6 | Colpo Impression | VIA (2nd) | ||
| Sensitivity | 88.4 (81.9, 93.2) | 68.8 (60.4, 76.4) | 42.8 (34.4, 51.5) | 55.8 (47.1, 64.2) | 46.1 (36.8, 55.6) | Sensitivity | 90.6 (84.4, 94.9) | 42.8 (34.4, 51.5) | 55.8 (47.1, 64.2) | 46.1 (36.8, 55.6) |
| Specificity | 46.2 (42.9, 49.4) | 77.7 (74.8, 80.3) | 94.3 (92.6, 95.7) | 85.4 (83.0, 87.6) | 87.4 (85.1, 89.5) | Specificity | 41.6 (38.4, 44.8) | 94.2 (92.6, 95.6) | 84.2 (81.7, 86.5) | 86.1 (83.7, 88.3) |
| PPV | 19.6 (16.6, 23.0) | 31.5 (26.3, 37.0) | 52.7 (43.0, 62.2) | 36.3 (29.8, 43.2) | 31.5 (24.6, 39.2) | PPV | 18.6 (15.7, 21.7) | 52.2 (42.6, 61.7) | 34.2 (28.0, 40.8) | 29.3 (22.8, 63.5) |
| NPV | 96.40 (94.21, 97.93) | 94.36 (92.48, 95.89) | 91.71 (89.78, 93.38) | 92.85 (90.91, 94.49) | 92.78 (90.84, 94.42) | NPV | 96.77 (94.55, 98.27) | 91.80 (89.88, 93.45) | 92.83 (90.89, 94.47) | 92.77 (90.82, 94.41) |
| OR | 6.5 (3.8, 11) | 7.7 (5.2, 11) | 12 (8.0, 19) | 7.4 (5.1, 11) | 5.9 (3.9, 9.0) | OR | 6.8 (3.8, 12) | 12.2 (7.9, 19) | 6.7 (4.6, 9.8) | 5.3 (3.5, 8.0) |
| careHPV+ (self) | HC2+ (self) | |||||||||
| HPV16/18/45 | HPV16/18/45 | |||||||||
| careHPV (≥10) | DNA | E6 | Colpo Impression | VIA (2nd) | HC2 (≥10) | E6 | Colpo Impression | VIA (2nd) | ||
| Sensitivity | 54.6 (45.2, 63.8) | 68.1 (58.9, 76.3) | 46.2 (37.0, 55.6) | 55.5 (46.1, 64.6) | 46.0 (36.0, 56.3) | Sensitivity | 69.7 (61.1, 77.4) | 43.9 (35.3, 52.8) | 55.3 (46.4, 64.0) | 46.8 (37.3, 56.6) |
| Specificity | 52.8 (49.6, 56.0) | 82.2 (79.6, 84.6) | 96.0 (94.6, 97.2) | 86.9 (84.6, 89.0) | 88.6 (86.4, 90.5) | Specificity | 49.8 (46.9, 52.7) | 96.1 (94.8, 97.1) | 86.1 (84.0, 88.0) | 87.9 (85.9, 89.7) |
| PPV | 12.6 (9.86, 15.8) | 32.3 (26.5, 38.4) | 59.1 (48.5, 69.2) | 34.6 (27.8, 41.8) | 29.9 (22.8, 37.8) | PPV | 13.3 (10.8, 16.0) | 55.2 (45.2, 65.0) | 30.5 (24.8, 36.8) | 26.7 (20.6, 33.5) |
| NPV | 90.32 (87.56, 92.65) | 95.38 (93.72, 96.71) | 93.48 (91.74, 94.94) | 94.00 (92.22, 95.47) | 93.93 (92.16, 95.41) | NPV | 93.71 (91.53, 95.47) | 93.95 (92.47, 95.22) | 94.61 (93.10, 95.87) | 94.61 (93.10, 95.87) |
| OR | 1.4 (0.92, 2.0) | 9.8 (6.5, 15) | 21 (13, 34) | 8.3 (5.5, 12) | 6.6 (4.3, 10) | OR | 2.3 (1.6, 3.4) | 19 (12, 30) | 7.7 (5.3, 11) | 6.4 (4.2, 9.6) |
Odds ratios with 95% confidence intervals as a measure of association are also shown.
Abbreviations: CIN, cervical intraepithelial neoplasia; CIN2, grade 2; CIN2+, grade 2 or more severe; NPV, negative predictive value; OR, odds ratio; PPV, positive predictive value; rlu/pc, relative light units per positive control (signal strength); VIA, visual inspection with acetic acid.