title: International collaborative proficiency study of Human Papillomavirus type 16 serology.
abstract: 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.
authors.affiliation: WHO HPV LabNet Global Reference Laboratory, Department of Clinical and Medical Microbiology, Skåne and Lund University, Malmö, Sweden.
authors.forename: Carina
authors.initials: C
authors.lastname: Eklund
authors.forename: Elizabeth R
authors.initials: ER
authors.lastname: Unger
authors.forename: Denise
authors.initials: D
authors.lastname: Nardelli-Haefliger
authors.forename: Tiequn
authors.initials: T
authors.lastname: Zhou
authors.forename: Joakim
authors.initials: J
authors.lastname: Dillner
mesh_terms: D000956:Antigens, Viral; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods / Q000592:standards; D005260:Female; D006801:Humans; D007391:International Cooperation; D030361:Papillomavirus Infections / Q000175:diagnosis*; D012015:Reference Standards; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods / Q000592:standards; D014773:Virology / Q000379:methods* / Q000592:standards*; D022701:Virosomes
chemical_list: D000956:Antigens, Viral; D022701:Virosomes