Proficiency panels – International Human Papillomavirus Reference Center

Accurate and internationally comparable human papillomavirus (HPV) DNA typing is essential for HPV vaccine research and for HPV surveillance. With the objective of improving and standardizing the quality of HPV laboratory services, the WHO established a global HPV laboratory network (HPV LabNet) in 2005. The main activities within the HPV LabNet were the harmonization and standardization of the laboratory procedures used for HPV vaccine research and HPV vaccination program impact monitoring by the development of internationally comparable quality assurance methods, international standards, and reference reagents, as well as a laboratory manual for vaccinology.

In 2008, recombinant HPV DNA plasmids were used to establish international standards for HPV16 and HPV18 DNA, with an assigned potency in international units. That same year, WHO HPV LabNet conducted the first (typing) proficiency study that was open for participation from laboratories worldwide based on HPV DNA plasmids containing the genomes of 14 oncogenic and 2 benign HPV types. Since then, the (typing) proficiency study has been repeated, demonstrating that it is possible to perform continuous global studies based on plasmid DNA with unitage traceable to international standards, and that such studies can provide an overview of the status of HPV detection and typing methodologies worldwide.

As described above, the global HPV LabNet (typing) proficiency panels are designed for the typing needs in HPV vaccinology (complete HPV typing) and the proficiency criteria are not intended for clinical HPV screening purposes, as the requirements for analytical sensitivity may be different. For HPV screening, it is important to detect the most carcinogenic viruses (HPV16 and 18) at high sensitivity, but for less carcinogenic viruses it is not important to determine the exact type.

As the traditional HPV proficiency panel (typing panel) contains 44 challenge samples, many laboratories have asked for a smaller proficiency panel tailored to what is important for assessing the quality of HPV screening services. Testing for oncogenic HPV in cervical cancer screening is a globally recommended health policy and therefore, the International HPV Reference Center is now conducting a parallel screening proficiency study for screening purposes. The so called, HPV screening proficiency study.

Proficiency panels available:

The global HPV LabNet TYPING proficiency panels are designed for the typing needs (vaccinology). The panel consists of 41 samples containing purified whole genomic plasmids of HPV 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68a and 68b in a background of human cellular DNA. Each sample may contain no HPV at all, single types or a mixture of HPV types at varying concentrations. Three additional samples are included in the panel comprising cell suspensions to allow evaluation of DNA extraction methods. Participant laboratories will be asked to perform HPV typing using one or more of their usual assays on the 44 challenges in this panel. This challenge is intended to evaluate assays that type HPV and is not appropriate for assays that detect HPV in general or grouped as high risk/low risk.
The global HPV LabNet SCREENING proficiency panels are designed for the screening needs. The panels consist of 12 samples containing purified whole genomic plasmids of HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68a and 68b in a background of human cellular DNA. Participant laboratories will be asked to perform HPV screening using one or more of their usual HPV screening assays. The panel will evaluate the detection of the major oncogenic HPV types as well as detection of other oncogenic HPV types in groups.

To register for any of the HPV proficiency panels (typing/screening) and get more information contact EQUALIS: info@equalis.se.

Publications

2024
Continuous Global Improvement of Human Papillomavirus (HPV) Genotyping Services: The 2022 and 2023 HPV LabNet International Proficiency Studies. Arroyo LS, Eklund C, Lagheden C, et al.

2023
First international proficiency study on human papillomavirus testing in cervical cancer screening. Yilmaz E, Eklund C, Lagheden C, et al.

2022
I mproving human papillomavirus (HPV) testing in the cervical cancer elimination era: The 2021 HPV LabNet international proficiency study. Arroyo Mühr LS, Eklund C, Lagheden C, et al.

2021
The 2019 HPV Labnet international proficiency study: Need of global Human Papillomavirus Proficiency Testing.. Eklund C, Arroyo Mühr LS, Lagheden C, et al.

2018
Continuing global improvement in human papillomavirus DNA genotyping services: The 2013 and 2014 HPV LabNet international proficiency studies. Eklund C, Forslund O, Walling KL, et al.

2014
Global improvement in genotyping of human papillomavirus DNA: The 2011 HPV Labnet International Proficiency Study. Eklund C, Forslund O, Wallin KL, et al.

2012
The 2010 global proficiency study of human papillomavirus genotyping in vaccinology. Eklund C, Forslund O, Wallin KL, et al.

2010
Global proficiency study on human papillomavirus genotyping. Eklund C, Zhou T, Dillner J, et al.

Reports