The 2019 HPV Labnet international proficiency study : Need of global Human Papillomavirus Proficiency Testing
(2021) In Journal of Clinical Virology 141.- Abstract
Background:: Accurate and internationally comparable human papillomavirus (HPV) testing services are essential for cervical cancer elimination programs. The WHO HPV Laboratory Network started issuing international HPV testing proficiency panels in 2008. Objectives:: We report the results of the 2019 global proficiency study and evaluate the proficiency over time. Study design:: The proficiency panel contained 40 coded samples containing mixes of purified HPV types (HPV6/11/16/18/31/33/35/39/45/51/52/56/58/59/68a/68b) and 4 controls. Proficiency required detection of both single and multiple infections of 50 International Units of HPV 16/18, of 500 genome equivalents (10x higher concentration) for other HPV types, and no false positives... (More)
Background:: Accurate and internationally comparable human papillomavirus (HPV) testing services are essential for cervical cancer elimination programs. The WHO HPV Laboratory Network started issuing international HPV testing proficiency panels in 2008. Objectives:: We report the results of the 2019 global proficiency study and evaluate the proficiency over time. Study design:: The proficiency panel contained 40 coded samples containing mixes of purified HPV types (HPV6/11/16/18/31/33/35/39/45/51/52/56/58/59/68a/68b) and 4 controls. Proficiency required detection of both single and multiple infections of 50 International Units of HPV 16/18, of 500 genome equivalents (10x higher concentration) for other HPV types, and no false positives (stricter requirement compared to previous panels). Results:: Seventy-eight laboratories submitted 110 datasets with 38 different assays. Most samples (38/44) were reported with 100% proficiency in most datasets. Mostly commercial assays were used (88/110 datasets). Overall, 47.3% of the datasets were 100% proficient. False positivity was detected in at least one sample in 30.1% of datasets. When analysing all datasets ever since 2008 using exactly the same proficiency criteria, there was a steady improvement up to 2017 (the proportion of datasets being completely proficient increased from 25% to 73%). However, in the 2019 proficiency testing the proportion of fully proficient datasets dropped to 50%. Conclusions:: Although we initially documented a worldwide improvement in comparability and reliability of HPV testing services, the trend now appears to be reversed. In response, the International HPV Reference Center will provide support for improved quality of laboratory services, including issuing of global proficiency panels every year.
(Less)
- author
- Eklund, Carina LU ; Mühr, Laila Sara Arroyo ; Lagheden, Camilla LU ; Forslund, Ola LU ; Robertsson, Karin Dahlin and Dillner, Joakim LU
- organization
- publishing date
- 2021-08-01
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- cancer eradication, Cervical cancer, Human papillomavirus, International standards, Quality assurance
- in
- Journal of Clinical Virology
- volume
- 141
- article number
- 104902
- publisher
- Elsevier
- external identifiers
-
- scopus:85109503090
- pmid:34186414
- ISSN
- 1386-6532
- DOI
- 10.1016/j.jcv.2021.104902
- language
- English
- LU publication?
- yes
- id
- 7aa14640-0074-4bad-a31b-1c80aad7c316
- date added to LUP
- 2021-08-18 09:11:51
- date last changed
- 2024-06-15 14:36:26
@article{7aa14640-0074-4bad-a31b-1c80aad7c316,
abstract = {{<p>Background:: Accurate and internationally comparable human papillomavirus (HPV) testing services are essential for cervical cancer elimination programs. The WHO HPV Laboratory Network started issuing international HPV testing proficiency panels in 2008. Objectives:: We report the results of the 2019 global proficiency study and evaluate the proficiency over time. Study design:: The proficiency panel contained 40 coded samples containing mixes of purified HPV types (HPV6/11/16/18/31/33/35/39/45/51/52/56/58/59/68a/68b) and 4 controls. Proficiency required detection of both single and multiple infections of 50 International Units of HPV 16/18, of 500 genome equivalents (10x higher concentration) for other HPV types, and no false positives (stricter requirement compared to previous panels). Results:: Seventy-eight laboratories submitted 110 datasets with 38 different assays. Most samples (38/44) were reported with 100% proficiency in most datasets. Mostly commercial assays were used (88/110 datasets). Overall, 47.3% of the datasets were 100% proficient. False positivity was detected in at least one sample in 30.1% of datasets. When analysing all datasets ever since 2008 using exactly the same proficiency criteria, there was a steady improvement up to 2017 (the proportion of datasets being completely proficient increased from 25% to 73%). However, in the 2019 proficiency testing the proportion of fully proficient datasets dropped to 50%. Conclusions:: Although we initially documented a worldwide improvement in comparability and reliability of HPV testing services, the trend now appears to be reversed. In response, the International HPV Reference Center will provide support for improved quality of laboratory services, including issuing of global proficiency panels every year.</p>}},
author = {{Eklund, Carina and Mühr, Laila Sara Arroyo and Lagheden, Camilla and Forslund, Ola and Robertsson, Karin Dahlin and Dillner, Joakim}},
issn = {{1386-6532}},
keywords = {{cancer eradication; Cervical cancer; Human papillomavirus; International standards; Quality assurance}},
language = {{eng}},
month = {{08}},
publisher = {{Elsevier}},
series = {{Journal of Clinical Virology}},
title = {{The 2019 HPV Labnet international proficiency study : Need of global Human Papillomavirus Proficiency Testing}},
url = {{http://dx.doi.org/10.1016/j.jcv.2021.104902}},
doi = {{10.1016/j.jcv.2021.104902}},
volume = {{141}},
year = {{2021}},
}