The first international proficiency study of HPV testing for cervical cancer screening has been launched.

Globally, 84 laboratories participated.

122/158 (77%) of datasets were fully proficient.

There was mostly high sensitivity and few false positives, but high sensitivity for viruses with little risk resulted in suboptimal specificity.

Although cervical screening using Human Papillomavirus (HPV) testing is globally recommended public health policy, there has been no international proficiency studies specifically targeting HPV testing for cervical screening.

To obtain the first global overview of the current proficiency of HPV testing services for cervical cancer screening.

A coded proficiency panel of 12 samples containing HPV types 16, 18, 31, 33, 45, 52, 58 or 35/39/51/56/59/68 in human DNA in varying amounts as well as control. Datasets detecting at least a) 10 International Units (IU) of HPV16 and 18, b) 1000 IU of HPV types 31, 33, 45, 52, 58 and c) having no false positives were considered proficient.

In total, 84 laboratories worldwide submitted 158 datasets (some laboratories used >1 HPV testing platform). Of those, 122 (77%) were 100% proficient. Only 14/158 datasets (9%) contained false positive results. Comparison of results with assays approved by the Food and Drug Administration (FDA) suggest that future proficiency requirements should also accommodate assays detecting only 100 IU of HPV16/18. A pool of low oncogenicity HPV types that contributed very little to sensitivity, but adversely affected specificity, was detectable by most datasets.

Internationally recognized proficiency studies of HPV screening, traceable to international standards, provided an overview of current testing performance. There was a high level of proficiency in terms of sensitivity and few false positives, but specificity was not optimal and further research on optimal specificity of HPV screening tests may be warranted.

Human papillomavirus

Cervical cancer

Screening

Proficiency

HPV testing

International standards

Region of the Americas

Food and Drug Administration

International Agency for Research on Cancer

International HPV Reference Center

International Standards

The Global HPV Laboratory Network

South-East Asian Region

World Health Organization

Western-Pacific Region

© 2023 The Author(s). Published by Elsevier B.V.