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?:abstract
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The S5-methylation test, an alternative to cytology and HPV16/18 genotyping to triage high-risk HPV-positive (hrHPV+) women, has not been widely validated in Low-Middle-Income countries (LMICs). We compared S5 to HPV16/18 and cytology to detect cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and CIN3+ in hrHPV+ women selected from a randomized pragmatic trial of 2661 Colombian women with an earlier-borderline abnormal cytology. We included all hrHPV+ CIN2 and CIN3+ cases (n = 183) age matched to 183 < CIN2 hrHPV+. Baseline specimens were HPV-genotyped and tested by S5-methylation, blinded to cytology, histology, and initial HPV results. We evaluated the test performance of pre-defined S5-classifier (cut-point 0.8) and a post-hoc classifier at a different cut-point (3.1). S5 sensitivity for CIN2+ was 82% (95%CI 76.4-87.5) and for CIN3+ 77.08% (95%CI 65.19-88.97). S5 sensitivity was higher than HPV16/18 sensitivity (48.1%, 95%CI 40.85-55.33) or cytology (31.21%, 95%CI 24.50-37.93) but with lower specificity (35%, 95%CI 28.1-42). At cut-point 3.1, S5 sensitivity for CIN2+ (55.2%, 95%CI 48-62.4) or CIN3+ (64.6%,95%CI 51.0-78.1) was also superior to HPV16/18 (P < 0.05) or cytology (P < 0.0001). At this cut-point S5 specificity (76%, 95%CI 69.8-82.1 for
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