74 Chapter 3 58 (18.4%) had CIN2. Three-hundred ninety-nine (55.8%) women had normal cytology at baseline, of whom 359 (90.0%) underwent repeat cytology at 6 months. A total of 281 (78.3%) women had a normal repeat cytology result and 78 (21.7%) an abnormal repeat cytology result, of whom 10 (12.8%) women had CIN3 and 14 (17.9%) CIN2 (Figure 3.1). The data on revision diagnosis, available for 696 women (97.3%). Pathology review using biomarkers Ki-67 and p16INK4A demonstrated an excellent correlation with the original diagnosis (ICC 0.942; 95% CI 0.933-0.950; Supplementary Table 3.1). In the analyses presented below the original histology scores obtained during regular care are used; results using revision diagnosis are presented in Supplementary Information. Sensitivity Specificity PPV NPV A Cytology n/N % 95% CI n/N % 95% CI % 95% CI % 95% CI CIN3+ 81/91 89.0% (82.6-95.4%) 389/624 62.3% (58.5-66.1%) 25.6% (20.8-30.4%) 97.5% (96.0-99.0%) CIN2+ 138/163 84.7% (79.1-90.2%) 374/552 67.8% (63.9-71.7%) 43.7% (38.2-49.1%) 93.7% (91.4-96.1%) B HPV16/18 genotyping CIN3+ 61/83 73.5% (64.0-83.0%) 383/567 67.5% (63.7-71.4%) 24.9% (19.5-30.3%) 94.6% (92.4-96.8%) CIN2+ 76/146 68.7% (51.6-67.5%) 346/504 68.7% (64.6-72.7%) 35.5% (29.5-41.5%) 85.4% (82.0-88.9%) C ASCL1/LHX8 methylation* CIN3+ 70/91 76.9% (68.3-85.6%) 465/624 74.5% (71.1-77.9%) 30.6% (24.6-36.5%) 95.7% (93.9-97.5%) CIN2+ 97/163 59.5% (52.0-67.0%) 420/552 76.1% (72.5-79.6%) 42.4% (36.0-48.8%) 86.4% (83.4-89.5%) D Cytology + HPV16/18 genotyping CIN3+ 79/83 95.2% (90.6-99.8%) 248/567 43.7% (39.7-47.8%) 19.8% (15.9-23.8%) 98.4% (96.9-100.0%) CIN2+ 130/146 89.0% (84.0-94.1%) 236/504 46.8% (42.5-51.2%) 32.7% (28.1-37.3%) 93.7% (90.6-96.7%) E ASCL1/LHX8 methylation* + HPV16/18 genotyping CIN3+ 72/83 86.7% (79.5-94.0%) 302/567 53.3% (49.2-57.4%) 21.4% (17.0-25.7%) 96.5% (94.4-98.5%) CIN2+ 112/146 76.7% (69.9-83.6%) 279/504 55.4% (51.0-59.7%) 33.2% (28.2-38.3%) 89.1% (85.7-92.6%) *using a predefined theshold (70% specificity) Abbreviations: CI, confidence interval; CIN, cervical intraepithelial neoplasia; HPV, human papillomavirus; n, number of; N, group size; NPV, negative predicted value; PPV, positive predicted value Table 3.1 Sensitivity and specificity of baseline cytology, genotyping and ASCL1/LHX8 methylation for detection of CIN3+ and CIN2+. Abbreviations: CI, confidence interval; CIN, cervical intraepithelial neoplasia; HPV, human papillomavirus; n, number of; N, group size; NILM, negative for intraepithelial lesion or malignancy; NPV, negative predicted value; PPV, positive predicted value; BMD, borderline or mild dyskariosis; ASC-H, atypical squamous cells of undetermined significance-cannot exclude HSIL; ASC-US, atypical squamous cells of undetermined significance; LSIL, low-grade intraepithelial lesion; HSIL, high-grade intraepithelial lesion
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