Ralf Hilfrich

CER818: A Highly Specific and Sensitive HPV L1 High‐Risk Serological Lateral Flow Rapid Test for Early Detection of Cervical Cancer and Its Precursor Lesions

Objective: The objective of the study is to validate a new human papillomavirus (HPV) L1 high‐risk specific serological assay in a case‐control study.Methods: Serum samples of 138 patients (cervical intraepithelial neoplasia (CIN) 1, 2, and 3 and cervical cancer), 21 vaccinees, and 246 female controls were tested for the presence of HPV L1 high‐risk specific antibodies.Results: HPV L1 high‐risk antibodies were detected in 100% of the CIN1 and 2, 86.6% of the CIN3 and 82.4% of the cervical cancer cases, 100% of the vaccinees, and 3.9% of the female controls. Area under the curve (AUC) was calculated with 0.91 for controls versus CIN2+, 0.923 for controls versus CIN1+, and 0.968 for controls versus CIN1/2.Conclusion: The HPV L1 high‐risk specific serological lateral flow rapid test shows promising data in the field of early detection of HPV high‐risk induced cervical cancer and its precursor lesions. This easy‐to‐use, robust, and affordable approach could offer a chance to reach women in low‐ or middle‐income countries (LMICs) that could not be reached by HPV molecular testing–based cervical cancer screening programs.