Biomedical
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
Peer Reviewed
Abstract
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.
Key Questions
What is the purpose of the CER818 assay?
The CER818 assay is designed to detect antibodies against high-risk HPV L1 proteins, aiming to facilitate early identification of cervical cancer and its precursor lesions.
How was the CER818 assay validated?
The assay was validated through a case-control study involving serum samples from patients with varying degrees of cervical intraepithelial neoplasia (CIN) and cervical cancer, as well as from vaccinated individuals and female controls.
What were the key findings regarding the assay's sensitivity and specificity?
The CER818 assay demonstrated high sensitivity and specificity, detecting HPV L1 high-risk antibodies in 100% of CIN1 and CIN2 cases, 86.6% of CIN3 cases, and 82.4% of cervical cancer cases, with a low detection rate of 3.9% in female controls.
How does the CER818 assay compare to existing cervical cancer screening methods?
The CER818 assay offers a serological approach that is easy-to-use, robust, and affordable, potentially serving as an alternative or complement to current molecular testing-based cervical cancer screening programs, especially in low- or middle-income countries (LMICs).
What are the implications of the CER818 assay for cervical cancer screening in LMICs?
The assay's simplicity and cost-effectiveness could improve accessibility to cervical cancer screening in LMICs, aiding in early detection and potentially reducing cervical cancer incidence and mortality in these regions.
