Global performance of Human Papillomavirus Typing, Screening, and Evaluation as assessed using Proficiency Panels traceable to International Standards

BackgroundAccurate and comparable human papillomavirus (HPV) testing is essential for HPV vaccine research, HPV surveillance, and cervical cancer screening. In 2008, the WHO HPV Laboratory Network initiated global HPV proficiency testing traceable to International Standards (IS), which has been issued regularly since. Here, we summarize recent results and trends over time. MethodsThe HPV genotyping panel, used since 2008, consists of 43 blinded samples, including HPV 6, HPV 11, all oncogenic and vaccine-targeted HPV types, as well as extraction controls. A smaller screening panel, launched in 2022, includes 13 blinded samples designed for cervical screening needs. Laboratories worldwide test the panels using their own methods, and results are centrally evaluated at the International HPV Reference Center. Proficiency has hitherto been defined as absence of false positives, detection of HPV16/18 at 10 IU/{micro}L, and of other oncogenic types at 100 IU/{micro}L (genotyping) or 1000 IU/{micro}L (screening). ResultsParticipation in the genotyping panel increased from 54 laboratories in 2008 to >130 in 2021. Proficiency rose from [~]25% in early years to >80% by 2024, with >99% correct detection for most genotypes. Optional low-copy challenges (e.g., 1 IU/{micro}L HPV16/18) were detected by >95% of laboratories by 2024. Screening panel participation increased from 84 laboratories in 2022 to 132 in 2024, with overall proficiency improving from 77% to 95% and >96% datasets free of false positives. ConclusionsThe global HPV proficiency program enables global laboratory quality assurance. Annual proficiency testing is essential for high-performance HPV testing and evaluation supporting cervical cancer elimination. summaryGlobal HPV proficiency program traceable to international standards shows marked improvement from 2008-2024. Participation expanded worldwide, false positives decreased, and most HPV types reached near-universal detection. Annual proficiency testing supports HPV research, surveillance, screening and evaluation of novel assays.