Carina Eklund1, Ola Forslund2, Keng-Ling Wallin3, Joakim Dillner4. 1. Departments of Laboratory Medicine, Medical Epidemiology & Biostatistics, Karolinska Institute and Hospital, Stockholm, Sweden. 2. Department of Laboratory Medicine, Division of Medical Microbiology, Lund University, Skane Laboratory Medicine, Lund, Sweden. 3. EQUALIS AB, Uppsala, Sweden. 4. Departments of Laboratory Medicine, Medical Epidemiology & Biostatistics, Karolinska Institute and Hospital, Stockholm, Sweden. Electronic address: joakim.dillner@ki.se.
Abstract
BACKGROUND: Accurate and internationally comparable human papillomavirus (HPV) DNA detection and typing services are essential for HPV vaccine research and surveillance. OBJECTIVES: This study assessed the proficiency of different HPV typing services offered routinely in laboratories worldwide. STUDY DESIGN: The HPV Laboratory Network (LabNet) has designed international proficiency panels that can be regularly issued. The HPV genotyping proficiency panels of 2013 and 2014 contained 43 and 41 coded samples, respectively, 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 extraction controls. Proficient typing was defined as detection in both single and multiple infections of 50 International Units of HPV 16 and HPV 18 and 500 genome equivalents for the other 14 HPV types, with at least 97% specificity. RESULTS: Ninety-six laboratories submitted 136 datasets in 2013 and 121 laboratories submitted 148 datasets in 2014. Thirty-four different HPV genotyping assays were used, notably Linear Array, HPV Direct Flow-chip, GenoFlow HPV array, Anyplex HPV 28, Inno-LiPa, and PGMY-CHUV assays. A trend towards increased sensitivity and specificity was observed. In 2013, 59 data sets (44%) were 100% proficient compared to 86 data sets (59%) in 2014. This is a definite improvement compared to the first proficiency panel, issued in 2008, when only 19 data sets (26%) were fully proficient. CONCLUSION: The regularly issued global proficiency program has documented an ongoing worldwide improvement in comparability and reliability of HPV genotyping services.
BACKGROUND: Accurate and internationally comparable human papillomavirus (HPV) DNA detection and typing services are essential for HPV vaccine research and surveillance. OBJECTIVES: This study assessed the proficiency of different HPV typing services offered routinely in laboratories worldwide. STUDY DESIGN: The HPV Laboratory Network (LabNet) has designed international proficiency panels that can be regularly issued. The HPV genotyping proficiency panels of 2013 and 2014 contained 43 and 41 coded samples, respectively, 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 extraction controls. Proficient typing was defined as detection in both single and multiple infections of 50 International Units of HPV 16 and HPV 18 and 500 genome equivalents for the other 14 HPV types, with at least 97% specificity. RESULTS: Ninety-six laboratories submitted 136 datasets in 2013 and 121 laboratories submitted 148 datasets in 2014. Thirty-four different HPV genotyping assays were used, notably Linear Array, HPV Direct Flow-chip, GenoFlow HPV array, Anyplex HPV 28, Inno-LiPa, and PGMY-CHUV assays. A trend towards increased sensitivity and specificity was observed. In 2013, 59 data sets (44%) were 100% proficient compared to 86 data sets (59%) in 2014. This is a definite improvement compared to the first proficiency panel, issued in 2008, when only 19 data sets (26%) were fully proficient. CONCLUSION: The regularly issued global proficiency program has documented an ongoing worldwide improvement in comparability and reliability of HPV genotyping services.
Authors: Kaleigh A Connors; Stephen Abbott; Kamwing Jair; Jason Daniels; Madison Lintner; David Klein; Avery Wimpleberg; Jeanne A Jordan Journal: J Virol Methods Date: 2021-02-27 Impact factor: 2.623
Authors: Marion Saville; Farhana Sultana; Michael J Malloy; Louiza S Velentzis; Michael Caruana; Ellen L O Ip; Marco H T Keung; Karen Canfell; Julia M L Brotherton; David Hawkes Journal: J Clin Microbiol Date: 2019-01-30 Impact factor: 5.948