Table 4.
The clinical performance (sensitivity, specificity, PPV and NPV) with 95% confidence intervals of the triage tests/methods for detection of CIN3 or more severe (CIN3+) 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 | 88.5 (80.4, 94.1) | 77.1 (67.4, 85.0) | 54.2 (43.7, 64.4) | 63.5 (53.1, 73.1) | 52.6 (40.8, 64.2) | Sensitivity | 90.6 (82.9, 95.6) | 54.2 (43.7, 64.4) | 63.5 (53.1, 73.1) | 52.6 (40.8, 64.2) |
| Specificity | 44.7 (41.5, 47.9) | 76.5 (73.7, 79.1) | 93.8 (92.1, 95.2) | 84.4 (82.0, 86.6) | 86.5 (84.2, 88.6) | Specificity | 40.2 (37.1, 43.4) | 93.8 (92.1, 95.2) | 83.3 (80.8, 85.6) | 85.3 (82.9, 87.5) |
| PPV | 13.7 (11.1, 16.6) | 24.5 (19.8, 29.8) | 46.4 (37.0, 56.1) | 28.8 (22.8, 35.4) | 23.8 (17.6, 31.0) | PPV | 12.9 (10.5, 15.7) | 46.0 (36.6, 55.6) | 27.1 (21.4, 33.4) | 22.1 (16.3, 28.9) |
| NPV | 97.52 (95.61, 98.76) | 97.12 (95.67, 98.18) | 95.38 (93.85, 96.63) | 95.90 (94.34, 97.13) | 95.81 (94.24, 97.05) | NPV | 97.77 (95.80, 98.97) | 95.43 (93.91, 96.66) | 95.89 (94.33, 97.12) | 95.80 (94.23, 97.04) |
| OR | 6.2 (3.3, 12) | 11 (6.7, 18) | 18 (11, 29) | 9.4 (6.0, 15) | 7.1 (4.4, 12) | OR | 6.5 (3.3, 13) | 18 (11, 29) | 8.7 (5.6, 14) | 6.5 (4.0, 11) |
| 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 | 53.0 (41.7, 64.1) | 77.1 (66.6, 85.6) | 57.8 (46.5, 68.6) | 63.9 (52.6, 74.1) | 53.7 (41.1, 66.0) | Sensitivity | 70.0 (59.4, 79.2) | 55.6 (44.7, 66.0) | 63.3 (52.5, 73.2) | 54.2 (42.0, 66.0) |
| Specificity | 52.4 (49.2, 55.5) | 81.1 (78.6, 83.5) | 95.5 (94.0, 96.7) | 86.1 (83.8, 88.2) | 87.9 (85.7, 89.9) | Specificity | 49.2 (46.3, 52.0) | 95.6 (94.3, 96.6) | 85.3 (83.2, 87.2) | 87.2 (85.2, 89.0) |
| PPV | 8.53 (6.26, 11.3) | 25.5 (20.2, 31.4) | 51.6 (41.0, 62.1) | 27.7 (21.5, 34.7) | 23.4 (16.9, 30.9) | PPV | 9.09 (7.06, 11.5) | 47.6 (37.8, 57.6) | 23.8 (18.6, 29.8) | 20.0 (14.6, 26.3) |
| NPV | 93.01 (90.57, 94.98) | 97.69 (96.42, 98.60) | 96.43 (95.07, 97.50) | 96.60 (95.18, 97.70) | 96.52 (95.09, 97.62) | NPV | 95.75 (93.88, 97.18) | 96.73 (95.58, 97.66) | 96.97 (95.77, 97.91) | 96.99 (95.79, 97.92) |
| OR | 1.2 (0.79, 1.9) | 15 (8.5, 25) | 29 (17, 49) | 11 (6.8, 18) | 8.5 (5.1, 14) | OR | 2.3 (1.4, 3.6) | 27 (16, 44) | 10 (6.4, 16) | 8.1 (4.9, 13) |
Odds ratios (OR) with 95% confidence intervals as a measure of association are also shown. Abbreviations: CIN, cervical intraepithelial neoplasia; CIN2, grade 2; CIN3, grade 3; CIN2+, grade 2 or more severe; CIN3+, grade 3 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.