International collaborative proficiency study of Human Papillomavirus type 16 serology

Vaccine. 2012 Jan 5;30(2):294-9. doi: 10.1016/j.vaccine.2011.10.096. Epub 2011 Nov 8.


We performed an international proficiency study of Human Papillomavirus (HPV) type 16 serology. A common methodology for serology based on virus-like particle (VLP) ELISA was used by 10 laboratories in 6 continents. The laboratories used the same VLP reference reagent, which was selected as the most stable, sensitive and specific VLP preparation out of VLPs donated from 5 different sources. A blinded proficiency panel consisting of 52 serum samples from women with PCR-verified HPV 16-infection, 11 control serum samples from virginal women and the WHO HPV 16 International Standard (IS) serum were distributed. The mean plus 3 standard deviations of the negative control serum samples was the most generally useful "cut-off" criterion for distinguishing positive and negative samples. Using sensitivity of at least 50% and a specificity of 100% as proficiency criteria, 6/10 laboratories were proficient. In conclusion, an international Standard Operating Procedure for HPV serology, an international reporting system in International Units (IU) and a common "cut-off" criterion have been evaluated in an international HPV serology proficiency study.

Publication types

  • Evaluation Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antigens, Viral*
  • Enzyme-Linked Immunosorbent Assay / methods
  • Enzyme-Linked Immunosorbent Assay / standards
  • Female
  • Humans
  • International Cooperation
  • Papillomavirus Infections / diagnosis*
  • Reference Standards
  • Sensitivity and Specificity
  • Serologic Tests / methods
  • Serologic Tests / standards
  • Virology / methods*
  • Virology / standards*
  • Virosomes*


  • Antigens, Viral
  • Virosomes