DNA methylation for the triage of HPV-positive clinician-collected cervical samples 75 3 Sensitivity Specificity PPV NPV Relative risk A ASCL1/LHX8 methylation* n/N % 95% CI n/N % 95% CI % 95% CI % 95% CI 95% CI CIN3+ NILM 5/10 50.0% (19.0-81.0%) 298/389 76.6% (72.4-80.8%) 5.2% (0.8-9.7%) 98.3% (96.9-99.8%) 3.15 (0.93-10.67) low-grade cygtology 14/22 63.6% (43.5-83.7%) 145/193 75.1% (69.0-81.2%) 22.6% (12.2-33.0%) 94.8% (91.2-98.3%) 4.32 (1.91-9.78) high-grade cytology 51/59 86.4% (77.7-95.2%) 22/42 52.5% (37.3-67.5%) 71.8% (61.4-82.3%) 73.3% (57.5-89.2%) 2.69 (1.46-4.96) CIN2+ NILM 9/25 36.0% (17.2-54.8%) 287/374 76.7% (72.5-81.0%) 9.4% (3.5-15.2%) 94.7% (92.2-97.2%) 1.78 (0.81-3.87) low-grade cygtology 25/55 45.5% (32.3-58.6%) 123/160 76.9% (70.3-83.4%) 40.3% (28.1-52.5%) 80.4% (74.1-86.7% 2.06 (1.32-3.20) high-grade cytology 63/83 75.9% (66.7-85.1%) 10/18 55.6% (32.6-78.5%) 88.7% (81.4-96.1%) 33.3% (16.5-50.2%) 1.33 (1.01-1.74) B HPV16/18 genotyping CIN3+ NILM 8/10 80.0% (55.2-104.8%) 247/354 69.8% (65.0-74.6%) 7.0% (2.3-11.6%) 99.2% (98.1-100.3%) 8.66 (1.87-40.14) low-grade cygtology 13/22 59.1% (38.5-79.6%) 117/176 66.5% (59.5-73.5%) 18.1% (9.2-26.9%) 92.9% (88.4-97.4%) 2.53 (1.14-5.62) high-grade cytology 40/51 78.4% (67.1-89.7%) 19/37 51.4% (35.2-67.5%) 69.0% (57.1-80.9%) 63.3% (46.1-80.6%) 1.88 (1.14-3.10) CIN2+ NILM 10/23 43.5% (23.2-63.7%) 236/341 69.2% (64.3-74.1%) 8.7% (3.5-13.8%) 94.8% (92.0-97.5%) 1.67 (0.75-3.68) low-grade cygtology 26/52 50.0% (36.4-63.6%) 100/146 68.5% (61.0-76.0%) 36.1% (25.0-47.2%) 79.4% (72.3-86.4%) 1.75 (1.10-2.77) high-grade cytology 51/71 71.8% (61.4-82.3%) 10/17 58.8% (35.4-82.2%) 87.9% (79.5-96.3%) 33.3% (16.5-50.2%) 1.32 (1.01-1.73) C ASCL1/LHX8 methylation* + HPV16/18 genotyping CIN3+ NILM 8/10 80.0% (55.2-104.8%) 200/354 56.5% (51.3-61.7%) 4.9% (1.6-8.3%) 99.0% (97.6-100.4%) 4.42 (0.95-20.51) low-grade cygtology 17/22 77.3% (59.8-94.8%) 92/176 52.3% (44.9-59.7%) 16.8% (9.5-24.1%) 94.8% (90.4-99.2%) 5.61 (1.71-18.35) high-grade cytology 47/51 92.2% (84.8-99.5%) 10/37 27.0% (12.7-41.3%) 63.5% (52.5-74.5%) 71.4% (47.8-95.1%) 2.22 (0.95-5.18) CIN2+ NILM 13/23 56.5% (36.3-76.8%) 192/341 56.3% (51.0-61.6%) 8.0% (3.8-12.2%) 95.0% (92.1-98.0%) 1.43 (0.65-3.19) low-grade cygtology 36/52 69.2% (56.7-81.8%) 81/146 55.5% (47.4-63.5%) 35.6% (26.3-45.0%) 83.5% (76.1-90.9%) 2.66 (1.51-4.66) high-grade cytology 63/71 88.7% (81.4-96.1%) 6/17 35.3% (12.6-58.0%) 85.1% (77.0-93.2%) 42.9% (16.9-68.8%) 1.49 (0.94-2.37) *using a predefined theshold (70% specificity) Low-grade cytology: BMD equaling ASC-US/ASC-H/LSIL; High-grade cytology: >BMD equaling HSIL Table 3.2 Sensitivity and specificity of ASCL1/LHX8 methylation and HPV16/18 genotyping for the detection of CIN3+ and CIN2+, stratified by cytology class.
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