DNA methylation for the triage of HPV-positive clinician-collected cervical samples 81 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 5/8 62.5% (29.0-96.0%) 294/382 77.0% (72.7-81.2%) 5.4% (0.8-10.0%) 99.0% (97.9-100.1%) 5.32 (1.30-21.85) low-grade cygtology 9/15 60.0% (35.2-84.8%) 140/183 76.5% (70.4-82.6%) 17.3% (7.0-27.6%) 95.9% (92.7-99.1%) 4.21 (1.58-11.26) high-grade cytology 43/50 86.0% (76.4-95.6%) 21/44 47.7% (33.0-62.5%) 65.2% (53.7-76.6%) 75.0% (59.0-91.0%) 2.61 (1.34-5.07) CIN2+ NILM 9/17 52.9% (29.2-76.7%) 289/373 77.5% (73.2-81.7%) 9.7% (3.7-15.7%) 97.3% (95.5-99.1%) 3.59 (1.43-9.05) low-grade cygtology 17/38 44.7% (28.9-60.5%) 125/160 78.1% (71.7-84.5%) 32.7% (19.9-45.4%) 85.6% (79.9-91.3%) 2.27 (1.30-3.96) high-grade cytology 60/73 82.2% (73.4-91.0%) 15/21 71.4% (52.1-90.8%) 90.9% (84.0-97.8%) 53.6% (35.1-72.0%) 1.96 (1.31-2.94) B HPV16/18 genotyping CIN3+ NILM 5/8 62.5% (29.0-96.0%) 240/347 69.2% (64.3-74.0%) 4.5% (0.6-8.3%) 98.8% (97.4-100.2%) 3.62 (0.88-14.87) low-grade cygtology 8/15 53.3% (28.1-78.6%) 111/168 66.1% (58.9-73.2%) 12.3% (4.3-20.3%) 94.1% (89.8-98.3%) 2.07 (0.79-5.46) high-grade cytology 33/41 80.5% (68.4-92.6%) 18/40 45.0% (29.6-60.4%) 60.0% (47.1-72.9%) 69.2% (51.5-87.0%) 1.95 (1.05-3.61) CIN2+ NILM 10/17 58.8% (35.4-82.2%) 236/338 69.8% (64.9-74.7%) 8.9% (3.6-14.2%) 97.1% (95.0-99.2%) 0.63 (0.24-1.62) low-grade cygtology 19/37 51.4% (35.2-67.5%) 100/146 68.5% (61.0-76.0%) 29.2% (18.2-40.3%) 84.7% (78.3-91.2%) 1.92 (1.08-3.39) high-grade cytology 46/62 74.2% (63.3-85.1%) 10/19 52.6% (30.2-75.1%) 83.6% (73.9-93.4%) 38.5% (19.8-57.2%) 1.36 (0.98-1.88) C ASCL1/LHX8 methylation* + HPV16/18 genotyping CIN3+ NILM 7/8 87.5% (64.6-110.4%) 185/347 53.3% (48.1-58.6%) 4.1% (1.1-7.1%) 99.5% (98.4-100.5%) 7.70 (0.96-61.97) low-grade cygtology 12/15 80.0% (59.8-100.2%) 87/168 51.8% (44.2-59.3%) 12.9% (6.1-19.7%) 96.7% (93.0-100.4%) 3.87 (1.13-13.26) high-grade cytology 38/41 92.7% (84.7-100.7%) 10/40 25.0% (11.6-38.4% 55.9% (44.1-67.7%) 76.9% (54.0-99.8%) 0.72 (0.21-2.48) CIN2+ NILM 13/17 76.5% (56.3-96.6%) 182/338 53.8% (48.5-59.2%) 7.7% (3.7-11.7%) 97.8% (95.8-99.9%) 3.58 (1.19-10.76) low-grade cygtology 26/37 70.3% (55.5-85.0% 79/146 54.1% (46.0-62.2%) 28.0% (18.8-37.1%) 87.8% (81.0-94.5%) 2.29 (1.20-4.35) high-grade cytology 57/62 91.9% (85.2-98.7%) 8/19 42.1% (19.9-64.3%) 83.8% (75.1-92.6%) 61.5% (35.1-88.0%) 2.18 (1.09-4.37) *using a predefined theshold (70% specificity) Supplementary Table 3.3 Sensitivity and specificity of ASCL1/LHX8 methylation and HPV16/18 genotyping for the detection of CIN3+ and CIN2+, stratified by cytology class – subgroup with revision diagnosis.
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