WHO HPV Laboratory Network
The mission of the WHO global HPV Laboratory Network (LabNet) is to contribute to improving quality of laboratory services for effective surveillance and monitoring of HPV vaccination impact, through enhanced, state-of-the-art laboratory support.
WHO initiated these activities as part of a Bill and Melinda Gates Foundation funded project, contributed by a group of collaborating institutions working in partnership, which includes PATH in Seattle, Harvard University in Boston, IARC (International Agency for Research on Cancer) in Lyon, ICO (Institut Català d'Oncologia) in Barcelona and WHO in Geneva.
At the WHO meeting held in Geneva, 15-17 August 2005, a group of experts recommended the establishment of a global HPV laboratory network, to contribute to improving the quality of laboratory services for effective surveillance and HPV vaccination impact monitoring and to conduct training. Following an open call for applications to the participation in a WHO global HPV laboratory network (HPV LabNet) and external expert review of the proposals, the applicants with proven expertise in HPV have received site visits and to date, nine HPV expert laboratories around the world have been assigned as global/regional HPV reference laboratories. In response to the increasing global needs, additional expert laboratories may be assigned as regional reference laboratories if necessary. Moreover, expansion of the HPV LabNet to national level reference laboratories will be considered in due course.
One of the three objectives of the work to be carried out by WHO was "to harmonize and standardize laboratory testing procedures and create an HPV laboratory network worldwide" to support consistent laboratory evaluation of regional disease burden and monitor the performance of HPV vaccines.
It is envisaged that the HPV LabNet would speed up the introduction of HPV vaccines by facilitating the implementation of validated, standardized laboratory procedures; by developing quality assurance system and proficiency testing; by training personnel; and by providing a network for surveillance.
The HPV LabNet will ensure the availability of competent laboratory services worldwide for the evaluation of HPV DNA and antibody detection in biological specimens through capacity-building and strengthening for those who are in need by providing 1) up-to-date technical information, 2) technical advice and guidance and 3) training on laboratory practice and quality assurance. Specific tasks are defined for each reference laboratory based on the expertise and capacity. In addition, WHO reference laboratories may offer, upon request, confirmatory testing of a subset of samples in the context of monitoring vaccine performance in clinical trials and following vaccine introduction.
Linked to this activity is the development and use of international standard reagents and operation procedures in laboratory testing. WHO is developing and establishing such standards to support consistent laboratory evaluation of regional disease burden and monitor the performance of vaccine candidates tested in field studies, and the HPV LabNet is contributing to this effort.
Meeting reports and Related documents
WHO meeting on the standardization of HPV assays and the role of WHO HPV LabNet in supporting vaccine introduction, 23-25 January 2008, WHO, Geneva, Switzerland
Meeting report for a WHO workshop and practical course on Human Papillomavirus (HPV) genotyping and HPV16/18 serology, 4-8 June, Lausanne, Switzerland
WHO Guidelines to assure the Quality, Safety and Efficacy of Recombinant Human papillomavirus Virus-Like Particle Vaccines, 2006
HPV Technical Workshop, 15-17 August 2005
HPV LabNet Newsletters
BS.2251 Guidelines on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant DNA technology: Appendix 7. Regulatory assessment of approved rDNA-derived biotherapeutics
BS.2252 Recommendations to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines
BS.2253 WHO GMP for Biological Products - Proposed replacement of TRS 822, Annex 1
NSB: BS.2268 Guidelines on the stability evaluation of vaccine for use under extended controlled temperature conditions
- WHO Implementation workshop of regulatory expectations and assessment of biotherapeutics in the Africa region, Accra, Ghana, 8-10 September 2015
- Expert Committee on biological Standardization, WHO Headquarters, Geneva, Switzerland, 12-16 October 2015
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