Reflections Regarding Validation of New HPV Tests With Reduced HPV Genotypes: Report From an IARC Expert Consultation

作者：Arianis Tatiana Ramírez, Gary M. Clifford, Joakim Dillner, Louise Kuhn, Marc Arbyn, Neerja Bhatla, Nicolas Wentzensen, Peter Sasieni, Priya Abraham, Mary Luz Rol, Maribel Almonte, Partha Sarathi Basu · 发表于：Journal of Medical Virology · 年份：2025 · DOI：10.1002/jmv.70310 · 被引用次数：12 · 研究领域：Cervical Cancer and HPV Research、Molecular Biology Techniques and Applications、Endometrial and Cervical Cancer Treatments

Of the 12 HPV genotypes classified as carcinogenic to humans (Group 1), over 95% of HPV-positive cervical cancers are linked to eight genotypes (HPV16/18/31/33/35/45/52/58). Screening programmes may consider HPV tests incorporating only these genotypes to improve screening efficiency and reduce programmatic costs. Validation of such tests requires fine-tuning of existing criteria. An expert group convened by the International Agency for Research on Cancer discussed how existing criteria by Meijer et al. for HPV screening clinical validation should be adapted to evaluate new reduced-valency HPV tests. Experts identified four key criteria: (1) Clinical performance criteria should meet WHO HPV test Target Product Profiles (TPP) minimal standards with high relative sensitivity ( ≥ 0.90 for CIN2+ and ≥ 0.95 for CIN3+) and relative specificity ( ≥ 0.98 for ≤ CIN1) to detect CIN2/3+ lesions associated with types targeted by the test, as established by a comparator test providing information on the presence of the targeted genotypes; (2) Comparator tests should be clinically validated according to Meijer criteria principles for comparator tests, and should offer HPV genotyping to detect at least the types included in the reduced-valency test; (3) Cervical samples should be representative of a population-based screening programme; (4) Intra- and inter-laboratory reproducibility should adhere to Meijer criteria and, preferentially also the more stringent TPP. As the global HPV type dis...