| 1. |
- Eklund, Carina, et al.
(författare)
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A global proficiency study of Human Papillomavirus genotyping.
- 2010
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Ingår i: Journal of Clinical Microbiology. - 1098-660X. ; 48:11, s. 4147-4155
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Tidskriftsartikel (refereegranskat)abstract
- Internationally comparable quality assurance of Human Papillomavirus (HPV) DNA detection and typing methods is essential for evaluation of HPV vaccines and effective monitoring and implementation of HPV vaccination programs. Therefore, the World Health Organisation (WHO) HPV Laboratory Network (LabNet) designed an international proficiency study. Following announcement at the WHO website, responding laboratories performed HPV typing using one or more of their usual assays on 43 coded samples composed of titration series of purified plasmids of sixteen HPV types (HPV 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). A detection of at least 50 International Units (IU) of HPV16 or HPV18 DNA and of 500 genome equivalents (GE) of the other 14 HPV types (in samples with single and multiple HPV types) was considered proficient. Fifty-four laboratories worldwide submitted a total of 84 data sets. There were more than 21 HPV genotyping assays used. Commonly used methods were Linear Array, Lineblot, Inno-LiPa, Clinical-Array, type-specific real-time PCR, PCR-Luminex and microarray assays. The major oncogenic HPV types (HPV16 and 18) were detected in 89.7% (70/78) and 92.2% (71/77) of data sets, respectively. HPV types 56, 59 and 68 were the least commonly detected types (in less than 80 % of data sets). Twenty-eight data sets reported multiple false positive results and were considered non-proficient. In conclusion, we found that international proficiency studies, traceable to International Standards, allow a standardised quality assurance of different HPV typing assays and enables a comparison of data generated from different laboratories worldwide.
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| 2. |
- Eklund, Carina, et al.
(författare)
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International collaborative proficiency study of Human Papillomavirus type 16 serology.
- 2012
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Ingår i: Vaccine. - : Elsevier BV. - 1873-2518 .- 0264-410X. ; 30, s. 294-299
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Tidskriftsartikel (refereegranskat)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.
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| 3. |
- Eklund, Carina, et al.
(författare)
-
The 2010 global proficiency study of Human Papillomavirus genotyping in vaccinology.
- 2012
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Ingår i: Journal of Clinical Microbiology. - 1098-660X. ; 50:7, s. 2289-2298
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Tidskriftsartikel (refereegranskat)abstract
- Accurate and internationally comparable Human Papillomavirus (HPV) DNA genotyping is essential both for evaluation of HPV vaccines and for effective monitoring and implementation of vaccination programs. World Health Organisation (WHO) HPV Laboratory Network (LabNet) regularly issues international proficiency studies. The 2010 HPV genotyping proficiency panel for HPV vaccinology contained 43 coded samples composed of purified plasmids of sixteen HPV types (HPV 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68a and 68b) and 3 coded extraction controls. Proficient typing was defined as detection in both single and multiple infections of 50 International Units (IU) of HPV 16 and HPV 18 DNA and 500 genome equivalents (GE) for the other 14 HPV types. Ninety-eight laboratories worldwide submitted a total of 132 datasets. Twenty-four different HPV genotyping assay methods were used, with Linear Array being most commonly used. Other major assays used were Lineblot/Inno-LiPa, CLART, type-specific real-time PCR, PCR-Luminex and different microarray assays. Altogether 72 data sets were proficient for detection of more than one type, only 26 data sets proficiently detected all sixteen HPV types. The major oncogenic HPV types, 16 and 18, were proficiently detected in 95.0% (114/120) and 87.0% (94/108) of datasets, respectively. Forty-six datasets reported multiple false positive results and were considered non-proficient. A trend towards increased sensitivity of assays was seen for the 41 laboratories that participated in both 2008 and 2010. In conclusion, continued global proficiency studies will be required for establishing comparable and reliable HPV genotyping services for vaccinology worldwide.
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