First international proficiency study on human papillomavirus testing in cervical cancer screening.
Cervical cancer
HPV testing
Human papillomavirus
International standards
Proficiency
Screening
Journal
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
ISSN: 1873-5967
Titre abrégé: J Clin Virol
Pays: Netherlands
ID NLM: 9815671
Informations de publication
Date de publication:
10 2023
10 2023
Historique:
received:
23
07
2023
revised:
23
08
2023
accepted:
02
09
2023
medline:
25
9
2023
pubmed:
10
9
2023
entrez:
9
9
2023
Statut:
ppublish
Résumé
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.
Sections du résumé
BACKGROUND
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.
OBJECTIVE
To obtain the first global overview of the current proficiency of HPV testing services for cervical cancer screening.
STUDY DESIGN
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.
RESULTS
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.
CONCLUSION
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.
Identifiants
pubmed: 37688950
pii: S1386-6532(23)00204-4
doi: 10.1016/j.jcv.2023.105581
pii:
doi:
Types de publication
Journal Article
Review
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
105581Informations de copyright
Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest Joakim Dillner was supported by the European Union Horizon 2020 Framework Programme for Research and Innovation through the RISCC Network (Grant No. 847845). Other authors have no conflict of interest to declare.