New WHO International Standards for HPV DNA now available

The NIBSC has developed new WHO International Standards for Human Papillomavirus (HPV) DNA for use in nucleic acid technology (NAT)-based assays for HPV detection and genotyping.

International Standards covering full-length HPV DNA sequences for low risk HPV types 6 and 11 and high risk HPV types 31, 33, 45, 52 and 58 are now available. The standards are freeze-dried, cell-free preparations of purified recombinant plasmid formulated in a background of human genomic DNA.

They were developed following the previous establishment of WHO International Standards for the high risk HPV types 16 and 18 in 2008.

Anticipated users of these standards include public health laboratories conducting cervical cancer screening and epidemiological studies, researchers investigating vaccine effectiveness, proficiency study organisers and diagnostic kit manufacturers.  

Measuring HPV infection

HPV infection is the cause of almost all cervical cancer cases worldwide as well as a substantial proportion of other anogenital and oropharyngeal cancers. There are approximately 200 different types of the virus which can be divided into high-risk types, known to be carcinogenic, and low risk types that are associated with warts.

Three vaccines are currently available to prevent HPV-related disease: a bivalent vaccine that targets the highest-risk types, 16 and 18; a quadrivalent vaccine that targets types 16, 18 and low risk types 6 and 11; and a nonavalent vaccine that targets types 16, 18, 6, 11 and additional high risk types 31, 33, 45, 52 and 58.

The use of assays for the detection and genotyping of HPV in clinical samples is a key method for measuring disease burden and evaluating the success of vaccination strategies.

HPV assays are also important diagnostic tools. In the UK, for example, HPV testing has recently replaced conventional cytology as the primary type of investigation in the NHS cervical cancer screening programme.

Consequently, there is a well-recognised need for HPV DNA standards that help to ensure that the assays used are accurate, sensitive and specific enough to provide meaningful and comparable results.

Providing a consistent results reporting system

The new International Standards for HPV DNA can be used to harmonise the amplification and detection steps of both monoplex and multiplex NAT-based assays.

They have been assigned arbitrary International Units (IU) and are intended to act as calibrators for routinely used secondary standards providing a consistent result reporting system that is independent of the laboratory or method used.

Dr Dianna Wilkinson, who led the collaborative study, comments that:

“The International Collaborative study demonstrated that the HPV DNA standards meet stringent WHO requirements to serve as International Standards. Their use will enable global harmonisation of HPV NAT assays, thus informing vaccination policies as well as the diagnosis and treatment of HPV-related disease.”

How to order

The International Standards are provided individually or as more economical collections of HPV types 16, 18, 6, 11 (NIBSC product code 19/224) and HPV types 31, 33, 45, 52, 58 (NIBSC product code 19/226).

To place an order please log in to your account or sign up for a new account.

If you would like more information about our HPV DNA International Standards, please contact enquiries@nibsc.org.