Abstract
Background: Only clinically validated HPV assays can be accepted in cervical cancer screening. Objectives: To update the list of high-risk HPV assays that fulfil the 2009 international validation criteria (Meijer-2009). Data Sources: PubMed/Medline, Embase, Scopus, references from selected studies; published in January 2014 to August 2020. Study eligibility criteria: HPV test validation studies and primary screening studies, involving testing with an index HPV test and a comparator HPV test with reporting of disease outcome (occurrence of histologically confirmed cervical precancer; CIN2+). Participants: Women participating in cervical cancer screening. Interventions: Testing with an index and a comparator HPV test of clinician-collected cervical specimens and assessment of disease outcome (<CIN2, CIN2+). Comparator HPV assays were HC2, GP5+/6+ PCR-EIA, recommended in validation guidelines, or tests with consistent previous validations. Methods: Assessment of relative clinical accuracy (including non-inferiority statistics index vs comparator assay) and test reproducibility in individual studies; random effects meta-analyses of the relative clinical sensitivity and specificity of index vs comparator tests. Results: Seven hrHPV DNA tests consistently fulfilled all validation criteria in multiple studies using predefined test positivity cut-offs (Abbott RealTime High Risk HPV, Anyplex II HPV HR Detection, BD Onclarity HPV Assay, Cobas 4800 HPV Test, HPV-Risk Assay, PapilloCheck HPV-Screening Test and Xpert HPV). Another assay (Alinity m HR HPV Assay) was fully validated in one validation study. The newer Cobas 6800 HPV Test, was validated in two studies against Cobas 4800. Other tests partially fulfilled the international validation criteria (Cervista HPV HR Test, EUROArray HPV, Hybribio's 14 High-Risk HPV, LMNX Genotyping Kit GP HPV, MALDI-TOF, RIATOL qPCR and a number of other in-house developed assays) since the non-inferior accuracy was reached after a posteriori cut-off optimization, inconsistent accuracy findings in different studies, and/or insufficient reproducibility assessment. The APTIMA HPV Assay targeting E6/E7 mRNA of hrHPV was fully validated in one formal validation study and showed slightly lower pooled sensitivity but higher specificity than the standard comparator tests in seven screening studies. However, the current international validation criteria relate to DNA assays. The additional requirement for longitudinal performance data required for non-DNA based HPV assays was not assessed in this review. Conclusions: Eleven hrHPV DNA assays fulfil all requirements for use in cervical cancer screening using clinician-collected specimens.
Original language | English |
---|---|
Pages (from-to) | 1083-1095 |
Number of pages | 13 |
Journal | Clinical Microbiology and Infection |
Volume | 27 |
Issue number | 8 |
Early online date | 2021 |
DOIs | |
Publication status | Published - Aug 2021 |
Keywords
- Cervical cancer
- Cervical cancer screening
- Diagnostic test accuracy: validation of tests
- Human papillomavirus
- Meta-analysis
- Systematic review
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In: Clinical Microbiology and Infection, Vol. 27, No. 8, 08.2021, p. 1083-1095.
Research output: Contribution to journal › Review article › Academic › peer-review
TY - JOUR
T1 - 2020 list of human papillomavirus assays suitable for primary cervical cancer screening
AU - Arbyn, Marc
AU - Simon, Marie
AU - Peeters, Eliana
AU - Xu, Lan
AU - Meijer, Chris J. L. M.
AU - Berkhof, Johannes
AU - Cuschieri, Kate
AU - Bonde, Jesper
AU - Ostrbenk Vanlencak, Anja
AU - Zhao, Fang-Hui
AU - Rezhake, Remila
AU - Gultekin, Murat
AU - Dillner, Joakim
AU - de Sanjosé, Silvia
AU - Canfell, Karen
AU - Hillemanns, Peter
AU - Almonte, Maribel
AU - Wentzensen, Nicolas
AU - Poljak, Mario
N1 - Funding Information: M. Arbyn, H. Berkhof, J. Dillner, C.J.L.M. Meijer, E. Peeters, M. Poljak and L. Xu were supported by the Horizon 2020 Framework Programme for Research and Innovation of the European Commission, through the RISCC Network (Grant No. 847845 ). Sciensanso, the employer of M. Arbyn received funding from the European Society of Gynaecological Oncology , the National Institute of Public Health and the Environment (Bilthoven, The Netherlands), German Guideline Program in Oncology (German Cancer Aid project), Haute Autorité de la Santé (Paris, France), World Health Organization (Geneva, Switzerland, via Agreement for Performance of Work for guidelines on Screening and Treatment of Pre-Invasive Cervical Disease) and the VALGENT and VALHUDES projects [16,98]. J. Bonde's institution has received research funding or consumables at reduced price or for free to support research from BD Diagnostics , Agena Bioscience , Genomica SAU , LifeRiver Biotech and QIAGEN . He has received honoraria for lectures from BD Diagnostics and Hologic Ltd. JB is appointed member of the National Danish Cervical Screening Committee by the Danish Health Authority. K. Canfell is co-principal investigator of an unrelated investigator-initiated trial of cervical screening in Australia (Compass; ACTRN12613001207707 and NCT02328872), which is conducted and funded by the VCS Foundation (VCS) , a government-funded health promotion charity. The VCS Foundation received equipment and a funding contribution from Roche Molecular Systems and Ventana USA but neither KC nor her institution on her behalf received direct funding from industry for this trial or any other project. K. Cuschieri declares no personal conflict of interest; her institution has received research funding or gratis consumables to support research from the following commercial entities in the last 3 years: Cepheid , Genomica , LifeRiver , Euroimmun , GeneFirst , SelfScreen , Qiagen , Hiantis , Seegene and Hologic. Karolinska University Hospital , the employer of J. Dillner, has received funding from Roche and Genomica . M. Gultekin received travel support and honoraria from Roche and Qiagen companies to be a speaker. P. Hillemannss received speaker's fee from GSK , Roche . C.J.L.M. Meijer is minority shareholder and part-time CEO of Self-screen B.V., a spin-off company of Amsterdam UMC location VUmc, which develops, manufactures and licences the High-Risk HPV assay and methylation marker assays for cervical cancer screening and holds patents on these tests. CJLMM has a very small number of shares of MDXHealth and QIAGEN, has received speakers fees from GSK , QIAGEN , and SPMSD/Merck , and served occasionally on the scientific advisory boards (expert meeting) of these companies. A. Oštrbenk Valenčak has received reimbursement of travel expenses for attending conferences and honoraria for speaking from Abbott Molecular, Qiagen and Seegene. M. Almonte, S. de Sanjosé, R. Rezhake, M. Simon, N. Wentzensen and FH Zhao declare no conflict of interest. Funding Information: M. Arbyn, H. Berkhof, J. Dillner, C.J.L.M. Meijer, E. Peeters, M. Poljak and L. Xu were supported by the Horizon 2020 Framework Programme for Research and Innovation of the European Commission, through the RISCC Network (Grant No. 847845). Sciensanso, the employer of M. Arbyn received funding from the European Society of Gynaecological Oncology, the National Institute of Public Health and the Environment (Bilthoven, The Netherlands), German Guideline Program in Oncology (German Cancer Aid project), Haute Autorit? de la Sant? (Paris, France), World Health Organization (Geneva, Switzerland, via Agreement for Performance of Work for guidelines on Screening and Treatment of Pre-Invasive Cervical Disease) and the VALGENT and VALHUDES projects [16,98]. J. Bonde's institution has received research funding or consumables at reduced price or for free to support research from BD Diagnostics, Agena Bioscience, Genomica SAU, LifeRiver Biotech and QIAGEN. He has received honoraria for lectures from BD Diagnostics and Hologic Ltd. JB is appointed member of the National Danish Cervical Screening Committee by the Danish Health Authority. K. Canfell is co-principal investigator of an unrelated investigator-initiated trial of cervical screening in Australia (Compass; ACTRN12613001207707 and NCT02328872), which is conducted and funded by the VCS Foundation (VCS), a government-funded health promotion charity. The VCS Foundation received equipment and a funding contribution from Roche Molecular Systems and Ventana USA but neither KC nor her institution on her behalf received direct funding from industry for this trial or any other project. K. Cuschieri declares no personal conflict of interest; her institution has received research funding or gratis consumables to support research from the following commercial entities in the last 3 years: Cepheid, Genomica, LifeRiver, Euroimmun, GeneFirst, SelfScreen, Qiagen, Hiantis, Seegene and Hologic. Karolinska University Hospital, the employer of J. Dillner, has received funding from Roche and Genomica. M. Gultekin received travel support and honoraria from Roche and Qiagen companies to be a speaker. P. Hillemannss received speaker's fee from GSK, Roche. C.J.L.M. Meijer is minority shareholder and part-time CEO of Self-screen B.V., a spin-off company of Amsterdam UMC location VUmc, which develops, manufactures and licences the High-Risk HPV assay and methylation marker assays for cervical cancer screening and holds patents on these tests. CJLMM has a very small number of shares of MDXHealth and QIAGEN, has received speakers fees from GSK, QIAGEN, and SPMSD/Merck, and served occasionally on the scientific advisory boards (expert meeting) of these companies. A. O?trbenk Valen?ak has received reimbursement of travel expenses for attending conferences and honoraria for speaking from Abbott Molecular, Qiagen and Seegene. M. Almonte, S. de Sanjos?, R. Rezhake, M. Simon, N. Wentzensen and FH Zhao declare no conflict of interest. Publisher Copyright: © 2021 The Authors Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/8
Y1 - 2021/8
N2 - Background: Only clinically validated HPV assays can be accepted in cervical cancer screening. Objectives: To update the list of high-risk HPV assays that fulfil the 2009 international validation criteria (Meijer-2009). Data Sources: PubMed/Medline, Embase, Scopus, references from selected studies; published in January 2014 to August 2020. Study eligibility criteria: HPV test validation studies and primary screening studies, involving testing with an index HPV test and a comparator HPV test with reporting of disease outcome (occurrence of histologically confirmed cervical precancer; CIN2+). Participants: Women participating in cervical cancer screening. Interventions: Testing with an index and a comparator HPV test of clinician-collected cervical specimens and assessment of disease outcome (<CIN2, CIN2+). Comparator HPV assays were HC2, GP5+/6+ PCR-EIA, recommended in validation guidelines, or tests with consistent previous validations. Methods: Assessment of relative clinical accuracy (including non-inferiority statistics index vs comparator assay) and test reproducibility in individual studies; random effects meta-analyses of the relative clinical sensitivity and specificity of index vs comparator tests. Results: Seven hrHPV DNA tests consistently fulfilled all validation criteria in multiple studies using predefined test positivity cut-offs (Abbott RealTime High Risk HPV, Anyplex II HPV HR Detection, BD Onclarity HPV Assay, Cobas 4800 HPV Test, HPV-Risk Assay, PapilloCheck HPV-Screening Test and Xpert HPV). Another assay (Alinity m HR HPV Assay) was fully validated in one validation study. The newer Cobas 6800 HPV Test, was validated in two studies against Cobas 4800. Other tests partially fulfilled the international validation criteria (Cervista HPV HR Test, EUROArray HPV, Hybribio's 14 High-Risk HPV, LMNX Genotyping Kit GP HPV, MALDI-TOF, RIATOL qPCR and a number of other in-house developed assays) since the non-inferior accuracy was reached after a posteriori cut-off optimization, inconsistent accuracy findings in different studies, and/or insufficient reproducibility assessment. The APTIMA HPV Assay targeting E6/E7 mRNA of hrHPV was fully validated in one formal validation study and showed slightly lower pooled sensitivity but higher specificity than the standard comparator tests in seven screening studies. However, the current international validation criteria relate to DNA assays. The additional requirement for longitudinal performance data required for non-DNA based HPV assays was not assessed in this review. Conclusions: Eleven hrHPV DNA assays fulfil all requirements for use in cervical cancer screening using clinician-collected specimens.
AB - Background: Only clinically validated HPV assays can be accepted in cervical cancer screening. Objectives: To update the list of high-risk HPV assays that fulfil the 2009 international validation criteria (Meijer-2009). Data Sources: PubMed/Medline, Embase, Scopus, references from selected studies; published in January 2014 to August 2020. Study eligibility criteria: HPV test validation studies and primary screening studies, involving testing with an index HPV test and a comparator HPV test with reporting of disease outcome (occurrence of histologically confirmed cervical precancer; CIN2+). Participants: Women participating in cervical cancer screening. Interventions: Testing with an index and a comparator HPV test of clinician-collected cervical specimens and assessment of disease outcome (<CIN2, CIN2+). Comparator HPV assays were HC2, GP5+/6+ PCR-EIA, recommended in validation guidelines, or tests with consistent previous validations. Methods: Assessment of relative clinical accuracy (including non-inferiority statistics index vs comparator assay) and test reproducibility in individual studies; random effects meta-analyses of the relative clinical sensitivity and specificity of index vs comparator tests. Results: Seven hrHPV DNA tests consistently fulfilled all validation criteria in multiple studies using predefined test positivity cut-offs (Abbott RealTime High Risk HPV, Anyplex II HPV HR Detection, BD Onclarity HPV Assay, Cobas 4800 HPV Test, HPV-Risk Assay, PapilloCheck HPV-Screening Test and Xpert HPV). Another assay (Alinity m HR HPV Assay) was fully validated in one validation study. The newer Cobas 6800 HPV Test, was validated in two studies against Cobas 4800. Other tests partially fulfilled the international validation criteria (Cervista HPV HR Test, EUROArray HPV, Hybribio's 14 High-Risk HPV, LMNX Genotyping Kit GP HPV, MALDI-TOF, RIATOL qPCR and a number of other in-house developed assays) since the non-inferior accuracy was reached after a posteriori cut-off optimization, inconsistent accuracy findings in different studies, and/or insufficient reproducibility assessment. The APTIMA HPV Assay targeting E6/E7 mRNA of hrHPV was fully validated in one formal validation study and showed slightly lower pooled sensitivity but higher specificity than the standard comparator tests in seven screening studies. However, the current international validation criteria relate to DNA assays. The additional requirement for longitudinal performance data required for non-DNA based HPV assays was not assessed in this review. Conclusions: Eleven hrHPV DNA assays fulfil all requirements for use in cervical cancer screening using clinician-collected specimens.
KW - Cervical cancer
KW - Cervical cancer screening
KW - Diagnostic test accuracy: validation of tests
KW - Human papillomavirus
KW - Meta-analysis
KW - Systematic review
UR - http://www.scopus.com/inward/record.url?scp=85108007665&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.cmi.2021.04.031
DO - https://doi.org/10.1016/j.cmi.2021.04.031
M3 - Review article
C2 - 33975008
SN - 1198-743X
VL - 27
SP - 1083
EP - 1095
JO - Clinical Microbiology and Infection
JF - Clinical Microbiology and Infection
IS - 8
ER -