Characteristics of study population
All the 7033 finished sample collection for HPV, cytology, and
methylation testing in this study. Figure 1 shows that 2246 of
7033 women included in the study, and that 602 (24.4%) in the IC
(immediate colposcopy) group, 1644 (66.7%) in the RF (repeat follow-up)
group. Among the 2246 women with either abnormal HPV results or abnormal
cytology results or both abnormal results, 1414 (57.34%) had an
adequate histological diagnosis, 943 of which had a diagnosis of ≤LSIL
(411 NEG and 532 LSIL) and 471 of ≥HSIL+ (401 HSIL and 70 cancers).
After exclusion of 4 samples (2 cases inadequate in sample materials and
corresponding controls), 41.8% (172/411), 55.8% (297/532), 99.5%
(399/401) and 100% (70/70) of women with negative, LSIL, HSIL or CC
histopathological diagnosis were included in this analysis.
Table 1 describes the characteristics of the included 468 ≥HSIL+ cases
and 468 ≤LSIL controls. Cases and controls had similar age, time to
diagnosis, marital status, number of sexual partners, smoking or not and
number of sexual partners. HPV16 was confirmed in 362 (38.6%), HPV18 in
279 (29.8%), HPV31 in 127 (13.5%) and HPV33 in 60 (6.4%) of all
samples. The sensitivity and specificity of S5 is different among IC
cohort and RF cohort (Table 2). In addition, the sensitivity (72.9%,
95% CI 70.7-75.1) of S5 methylation in RF cohort was better than the
performance of HPV16/18 (66.3%, 95% CI 62.1-70.3, P = 0.002)
and cytology (48.2, 95% CI 42.7-54.1, P = 0.008) in the RF
cohort.