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International collaborative proficiency study of Human Papillomavirus type 16 serology.

Eklund, Carina LU ; Unger, Elizabeth R ; Nardelli-Haefliger, Denise ; Zhou, Tiequn and Dillner, Joakim LU (2012) In Vaccine 30. p.294-299
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... (More)
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. (Less)
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author
; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Vaccine
volume
30
pages
294 - 299
publisher
Elsevier
external identifiers
  • wos:000299971800028
  • pmid:22079074
  • scopus:84355162812
  • pmid:22079074
ISSN
1873-2518
DOI
10.1016/j.vaccine.2011.10.096
language
English
LU publication?
yes
id
e020a2a8-b13e-4ce0-b2fc-4bee43645a45 (old id 2220842)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/22079074?dopt=Abstract
date added to LUP
2016-04-04 08:43:53
date last changed
2022-01-29 03:53:44
@article{e020a2a8-b13e-4ce0-b2fc-4bee43645a45,
  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.}},
  author       = {{Eklund, Carina and Unger, Elizabeth R and Nardelli-Haefliger, Denise and Zhou, Tiequn and Dillner, Joakim}},
  issn         = {{1873-2518}},
  language     = {{eng}},
  pages        = {{294--299}},
  publisher    = {{Elsevier}},
  series       = {{Vaccine}},
  title        = {{International collaborative proficiency study of Human Papillomavirus type 16 serology.}},
  url          = {{http://dx.doi.org/10.1016/j.vaccine.2011.10.096}},
  doi          = {{10.1016/j.vaccine.2011.10.096}},
  volume       = {{30}},
  year         = {{2012}},
}