International Collaborative Study on Human Papillomavirus Analytical Thresholds for Sensitivity and Specificity in Cervical Screening

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ABSTRACT Background Cervical screening using human papillomavirus (HPV) testing is a pillar of global cervical cancer elimination. However, different HPV assays vary in both the HPV types they detect as well as the minimum amount of virus they detect. The aim of this collaborative study was to define which HPV type-specific analytical threshold of detection provides optimal sensitivity and specificity of cervical screening. Methods 100 cervical intraepithelial neoplasia grade 2 or worse (CIN2+) cases and 200 matched population-based controls were obtained at the Swedish National HPV Reference Laboratory and analyzed by 10 laboratories across 10 countries. Cumulative sensitivity (weighted according to the global HPV type distribution in invasive cervical cancer (ICC)) and specificity were estimated at varying analytical detection thresholds. Results Consensus results found HPV in 99/100 CIN2+ cases and 52/200 controls. HPV16 prevalence declined in HPV-vaccinated birth cohorts, among both cases and controls. Line plots of 1-specificity and ICC-weighted sensitivity found optimal analytical detection thresholds as 3 International Units (IU)/µl for HPV16/18, 25 IU/µl for HPV31/33/35/45/52/58 and 100 genome equivalents/µl of HPV 39/51/56/59 resulting in 92.00% cumulative specificity and 90.08% ICC-weighted sensitivity. Conclusion An international collaborative study has identified HPV analytical detection thresholds optimizing sensitivity and specificity of cervical screening.

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