Performance of self-collected cervical samples in screening for future precancer using XXXX DNA testing.

@entity1 @entity5 @entity75 @entity1799 @entity1082
BACKGROUND: Self-collected @entity1082 ) testing could reduce barriers to @entity5 screening, with performance comparable to clinician-collected specimens. The ability of self-collected specimens to cross-sectionally and prospectively detect precursor lesions was investigated in an HPV vaccine randomized trial in Costa Rica. METHODS: In the trial, 7466 @entity1 age 18 to 25 years received an @entity1799 /18 or control vaccine and were followed at least annually for four years. In this secondary analysis, we included all @entity1 who provided a self-collected cervicovaginal specimen six months after enrollment (5109 @entity1 = full analytical cohort). A subset (615 @entity1 = restricted cohort) also had clinician-collected specimens at the six-month postenrollment visit. High-grade squamous @entity75 or repeat low-grade squamous @entity75 prompted colposcopic referral throughout the study. HPV testing was performed with SPF10PCR/DEIA/LiPA25. Cross-sectional and prospective sensitivity, specificity, and predictive values were estimated. RESULTS: In the full cohort, one-time HPV testing on self-collected samples detected prevalent CIN2+ with a sensitivity of 88.7% (95% confidence interval [CI] =77.0% to 95.7%) and a specificity of 68.9% (95% CI = 67.6% to 70.1%). For predicting incident CIN2+ in the subsequent four years, sensitivity was 73.9% (95% CI = 65.8% to 81.0%) and specificity 69.4% (95% CI = 68.1% to 70.7%). In the restricted cohort, for incident CIN2+, self-collected HPV was much more sensitive than cytology (80.0% vs 10.0%); relative sensitivity was 0.1 (95% CI = 0.03% to 0.5%). Furthermore, three times more @entity1 with normal baseline cytology developed incident CIN2+ than those with negative self-collected HPV. Self-collected and clinician-collected HPV testing had comparable performance. Agreement between self- and clinician-collected samples was 89.7% (kappa = 0.78, McNemar   2 = 0.62) for carcinogenic HPV types. CONCLUSIONS: Self-collected specimens can be used for HPV-based screening, providing sensitivity and specificity comparable with clinician-collected specimens and detecting disease earlier than cytology.
