Biologicals

WHO HPV LabNet

Projects

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 Standard (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:

Ongoing Projects of Development of Other HPV-related International Standards

• Reference panel of HPV type 16 and HPV type 18-specific monoclonal antibodies for quality control of HPV VLPs used in immunoassays;

• First International Standard for anti-HPV type 18 serum;

• First International Standards for HPV types 31, 33, 45, 52 and 58 DNA;

• First International Standards for HPV types 6 and 11 DNA.

WHO HPV LabNet Proficiency Studies for Evaluating HPV DNA Typing Methods

• HPV DNA detection and typing is essential for investigating the baseline of HPV prevalence, evaluation of HPV vaccines and monitoring of impact of HPV vaccination programmes. Use of qualified proficient laboratory assay methods and qualified performance will ensure generating reliable data to support decision-making on HPV vaccine introduction. The WHO HPV LabNet has developed an international proficiency panel for HPV DNA detection and typing, and organized annual proficiency studies since 2007. The 2008 WHO HPV LabNet Proficiency Study for Evaluating HPV DNA Typing Methods was open for global participation for all interested laboratories to evaluate different HPV tests in different laboratories.

There has been a huge interest from worldwide laboratories to participate in such WHO proficiency studies. In 2010, the 4th WHO HPV LabNet Proficiency Study for Evaluating HPV DNA Typing Methods is being organized. The WHO sought global participation in this international HPV DNA typing proficiency study. Laboratories that are or will be involved in HPV surveillance and/or vaccine development were most welcomed, with participation in the study being voluntary and free of charge. The panel is composed of 43 samples (purified whole genomic plasmids) of high/low-risk HPV types in a background of human DNA, and 3 extraction controls. Samples also include single and/or multiple types at varying concentrations traceable to established or candidate International Standards to evaluate sensitivity and type-specificity of detection.

Evaluation of HPV DNA Genotyping Assays and Serology Assays; Development of HPV Laboratory Manual

• Due to the variety of assay formats being used in the laboratories worldwide in HPV testing area and lack of standardized/harmonized assay methodologies, the WHO HPV LabNet has evaluated promising HPV genotyping assays and serology assays through its collaborative studies. Standard operating procedures (SOPs) were developed for genotyping assay and serology assay (VLP-ELISA, Neutralization assay), as examples.

• Based on knowledge and experience gained through its international collaborative studies over the past several years, the WHO HPV LabNet has developed an HPV Laboratory Manual with aims to assist in establishing the laboratory support required for implementation and monitoring of HPV vaccination programmes by:

  • Providing a brief summary of the biology and natural history of HPV and the worldwide burden of HPV-associated diseases;
  • Discussing the role of laboratories and the WHO HPV LabNet in supporting HPV surveillance and vaccination impact monitoring;
  • Describing the currently available International Standards and secondary standards for HPV testing and their appropriate use;
  • Providing guidance on specimen collection and handling for HPV testing;
  • Providing an overview of HPV serologic and DNA testing and provide example protocols evaluated by the WHO HPV LabNet; and
  • Providing guidance on laboratory quality assurance.

The manual should be useful for audiences involved in development and implementation of HPV vaccines, particularly those involved in generating or using HPV laboratory data. This document is a living document that will be amended in light of the future advances made in the area and future experience of HPV laboratory surveillance and vaccination monitoring in a global sense. This manual is to be published in the near future.

For more information about WHO HPV LabNet activities, please visit its website and semi-yearly newsletters on:

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