Biologicals

WHO HPV Laboratory Network

Introduction

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.

Objectives

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:

  • up-to-date technical information,
  • technical advice and guidance, and
  • 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

Established International Standards

Establishment of the First WHO International Standards for HPV Types 16 and 18 DNA

At the WHO 59th ECBS meeting, 13-17 October 2008, the First IS for HPV 16 DNA was adopted with an assigned potency: 5 x 106 International Unit (IU) per ampoule; the First IS for HPV type 18 DNA was adopted with an assigned potency: 5 x 106 IU per ampoule. These standards should be used to calibrate in-house or working standards for the amplification and detection of HPV types 16 and 18 DNA.

These ISs (product number 06/202 for HPV type 16 DNA; product number 06/206 for HPV type 18 DNA) are available through order from the National Institute for Biological Standards and Control (NIBSC), Potters Bar, South Mimms, Hertfordshire, UK at the following link:

Establishment of the First WHO International Standards (IS) for Anti-HPV Type 16 Serum

At the WHO 60th ECBS meeting, 19-23 October 2009, the WHO Reference Reagent of anti-HPV type 16 serum was adopted as the First IS for anti-HPV serum with an assigned potency of 5 IU per ampoule. This standard will serve as the primary biological standard for antibodies to HPV type 16. It may be used in immunoassays utilizing virus-like particles (VLPs) and neutralization tests utilizing pseudovirions (PsVs) of adequate sensitivity.

This IS (product number 05/134) is available through order from the National Institute for Biological Standards and Control (NIBSC), Potters Bar, South Mimms, Hertfordshire, Uk at the following link:

HPV LabNet Newsletters


Related information

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UPCOMING EVENTS


  • WHO Informal Consultation on development of guidelines on procedures and data requirements for changes to approved biotherapeutic products including biosimilars, Seoul, Republic of Korea, 27-28 April 2017
  • Working Group meeting on revision of WHO TRS 941, Annex 5: WHO biosafety risk assessment and Guidelines for the production and quality control of human influenza pandemic vaccines, Geneva, Switzerland, 9-10 May 2017
  • Working group meeting on Hepatitis E Vaccine, Geneva, Switzerland, 11-12 May 2017

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