Table 5.
Age ≥ 30 years | Age ≥ 30 years | |||||||
---|---|---|---|---|---|---|---|---|
N | HPV DNA+ | HPV E6/E7 mRNA+ | p16/Ki67+ | N | HPV DNA+ | HPV E6/E7 mRNA+ | p16/Ki67+ | |
n(%) | n(%) | n(%) | n(%) | n(%) | n(%) | |||
Endpoint = CIN2+ | ||||||||
CIN1- | 58 | 53(91.4%) | 35(60.3%) | 16(27.6%) | 188 | 150(79.8%) | 106(56.4%) | 27(14.4%) |
CIN2+ | 17 | 16(94.1%) | 13(76.5%) | 17(100%) | 37 | 37(100%) | 34(91.9%) | 36(97.3%) |
Sensitivity | 94.1% | 76.5% | 100% | 100% | 91.9% | 97.3% | ||
(95% CI) | (73.0, 99.0) | (52.7, 90.5) | (81.6, 100) | (90.6, 100) | (78.7, 97.2) | (86.2, 99.5) | ||
Specificity | 8.6% | 39.7% | 72.4% | 20.2% | 43.6% | 85.6% | ||
(95% CI) | (3.7, 18.6) | (28.1, 52.5) | (59.8, 82.3) | (15.1, 26.5) | (36.7, 50.8) | (79.9, 89.9) | ||
PPV | 23.2% | 27.1% | 51.5% | 19.8% | 24.3% | 57.1% | ||
(95% CI) | (14.8, 34.4) | (16.6, 41.0) | (35.2, 67.5) | (14.7, 26.1) | (17.9, 32.0) | (44.9, 68.6) | ||
NPV | 83.3% | 85.2% | 100% | 100% | 96.5% | 99.4% | ||
(95% CI) | (43.7, 97.0) | (67.5, 94.1) | (91.6, 100) | (90.8, 100) | (90.1, 98.8) | (96.6, 99.9) | ||
Youden | 2.7 | 16.2 | 72.4 | 20.2 | 35.5 | 82.9 | ||
Endpoint = CIN3+ | ||||||||
CIN2- | 68 | 62(91.2%) | 43(63.2%) | 26(38.2%) | 207 | 169(81.6%) | 123(59.4%) | 45(21.3%) |
CIN3+ | 7 | 7(100%) | 5(71.4%) | 7(100%) | 18 | 18(100%) | 17(94.4%) | 18(100%) |
Sensitivity | 100% | 71.4% | 100% | 100% | 94.4% | 100% | ||
(95% CI) | (64.6, 100) | (35.9, 91.8) | (64.6, 100) | (82.4, 100) | (74.2, 99.0) | (82.4, 100) | ||
Specificity | 8.8% | 36.8% | 61.8% | 18.4% | 40.6% | 78.3% | ||
(95% CI) | (4.1, 17.9) | (26.3, 48.6) | (49.9, 72.4) | (13.7, 24.2) | (34.1, 47.4) | (72.2, 83.3) | ||
PPV | 10.1% | 10.4% | 21.2% | 9.6% | 12.1% | 28.6% | ||
(95% CI) | (5.0, 19.5) | (4.5, 22.2) | (10.7, 37.8) | (6.2, 14.7) | (7.7, 18.6) | (18.9, 40.7) | ||
NPV | 100% | 92.6% | 100% | 100% | 98.8% | 100% | ||
(95% CI) | (61.0, 100) | (76.6, 97.9) | (91.6, 100) | (90.8, 100) | (93.6, 99.8) | (97.7, 100) | ||
Youden | 8.8 | 8.2 | 61.8 | 18.4 | 35.0 | 78.3 |
Note: PPV = positive predictive value; NPV = negative predictive value. Results in % with 95% confidence interval (95% CI). CIN1-: The diagnoses of cervical inflammation and CIN1 are referred as CIN1 -; CIN2+: the diagnoses of CIN2, CIN3 and carcinoma are referred as CIN2 +. CIN2-: cervical inflammation, CIN1 and CIN2 are referred as CIN2-. CIN3+: the diagnoses of CIN3 and carcinoma are referred as CIN3 +