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2. IPVS policy statement on HPV nucleic acid testing guidance for those utilising/considering HPV as primary precancer screening: Quality assurance and quality control issues.

Author

Garland, Suzanne, Iftner, Thomas, Cuschieri, Kate, Kaufmann, Andreas, Arbyn, Marc, de Sanjose, Silvia, Poljak, Mario, Dillner, Joakim, and Unger, Elizabeth

Subjects
Cervical, HPV, Primary, Screening, Validation, Female, Humans, Uterine Cervical Neoplasms, Mass Screening, Papillomavirus Infections, Early Detection of Cancer, Papillomaviridae, Quality Control, Nucleic Acids, Policy
Abstract

We advise that only clinically validated HPV assays which have fulfilled internationally accepted performance criteria be used for primary cervical screening. Further, assays should be demonstrated to be fit for purpose in the laboratory in which they will ultimately be performed, and quality materials manuals and frameworks will be helpful in this endeavor. Importantly, there is a fundamental shortage of well validated, low-cost, low complexity HPV tests that have demonstrated utility in a near-patient setting; representing a significant challenge and focus for future development in order to reach the WHOs goal of eliminating cervical cancer.

Published
2023

9. Human papillomavirus negative high grade cervical lesions and cancers: Suggested guidance for HPV testing quality assurance

Author

Prétet, Jean Luc, Arroyo Mühr, Laila Sara, Cuschieri, Kate, Fellner, María Dolores, Correa, Rita Mariel, Picconi, María Alejandra, Garland, Suzanne M., Murray, Gerald L., Molano, Monica, Peeters, Michael, Van Gucht, Steven, Lambrecht, Charlotte, Broeck, Davy Vanden, Padalko, Elizaveta, Arbyn, Marc, Lepiller, Quentin, Brunier, Alice, Silling, Steffi, Søreng, Kristiane, Christiansen, Irene Kraus, Poljak, Mario, Lagheden, Camilla, Yilmaz, Emel, Eklund, Carina, Thapa, Hem R., Querec, Troy D., Unger, Elizabeth R., and Dillner, Joakim

Published
2024
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13. IPVS policy statement on HPV nucleic acid testing guidance for those utilising/considering HPV as primary precancer screening: Quality assurance and quality control issues

Author

Garland, Suzanne M, Stanley, Margaret, Moscicki, Anna-Barbara, Woo, Yin Ling, Bhatla, Neerja, Chan, Karen L., Palefsky, Joel, Giuliano, Anna R, Kaufmann, Andreas M, de Sanjose, Silvia, Brotherton, Julia M.L., Feldman, Sarah, Garland, Suzanne M., Iftner, Thomas, Cuschieri, Kate, Arbyn, Marc, Poljak, Mario, Dillner, Joakim, and Unger, Elizabeth R.

Published
2023
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21. Criteria for second generation comparator tests in validation of novel HPV DNA tests for use in cervical cancer screening

Author

MMB, MMB Medische Staf, Infection & Immunity, Arbyn, Marc, Cuschieri, Kate, Bonde, Jesper, Schuurman, Rob, Cocuzza, Clementina, Broeck, Davy Vanden, Zhao, Fang Hui, Rezhake, Remila, Gultekin, Murat, de Sanjosé, Silvia, Canfell, Karen, Hawkes, David, Saville, Marion, Hillemanns, Peter, Dillner, Joakim, Berkhof, Johannes, Prétet, Jean Luc, Gheit, Tarik, Clifford, Gary, Basu, Partha, Almonte, Maribel, Wentzensen, Nicolas, Poljak, Mario, MMB, MMB Medische Staf, Infection & Immunity, Arbyn, Marc, Cuschieri, Kate, Bonde, Jesper, Schuurman, Rob, Cocuzza, Clementina, Broeck, Davy Vanden, Zhao, Fang Hui, Rezhake, Remila, Gultekin, Murat, de Sanjosé, Silvia, Canfell, Karen, Hawkes, David, Saville, Marion, Hillemanns, Peter, Dillner, Joakim, Berkhof, Johannes, Prétet, Jean Luc, Gheit, Tarik, Clifford, Gary, Basu, Partha, Almonte, Maribel, Wentzensen, Nicolas, and Poljak, Mario

Published
2024

22. Criteria for second generation comparator tests in validation of novel HPV DNA tests for use in cervical cancer screening

Author

Arbyn, M, Cuschieri, K, Bonde, J, Schuurman, R, Cocuzza, C, Broeck, D, Zhao, F, Rezhake, R, Gultekin, M, de Sanjosé, S, Canfell, K, Hawkes, D, Saville, M, Hillemanns, P, Dillner, J, Berkhof, J, Prétet, J, Gheit, T, Clifford, G, Basu, P, Almonte, M, Wentzensen, N, Poljak, M, Arbyn, Marc, Cuschieri, Kate, Bonde, Jesper, Schuurman, Rob, Cocuzza, Clementina, Broeck, Davy Vanden, Zhao, Fang‐Hui, Rezhake, Remila, Gultekin, Murat, de Sanjosé, Silvia, Canfell, Karen, Hawkes, David, Saville, Marion, Hillemanns, Peter, Dillner, Joakim, Berkhof, Johannes, Prétet, Jean‐Luc, Gheit, Tarik, Clifford, Gary, Basu, Partha, Almonte, Maribel, Wentzensen, Nicolas, Poljak, Mario, Arbyn, M, Cuschieri, K, Bonde, J, Schuurman, R, Cocuzza, C, Broeck, D, Zhao, F, Rezhake, R, Gultekin, M, de Sanjosé, S, Canfell, K, Hawkes, D, Saville, M, Hillemanns, P, Dillner, J, Berkhof, J, Prétet, J, Gheit, T, Clifford, G, Basu, P, Almonte, M, Wentzensen, N, Poljak, M, Arbyn, Marc, Cuschieri, Kate, Bonde, Jesper, Schuurman, Rob, Cocuzza, Clementina, Broeck, Davy Vanden, Zhao, Fang‐Hui, Rezhake, Remila, Gultekin, Murat, de Sanjosé, Silvia, Canfell, Karen, Hawkes, David, Saville, Marion, Hillemanns, Peter, Dillner, Joakim, Berkhof, Johannes, Prétet, Jean‐Luc, Gheit, Tarik, Clifford, Gary, Basu, Partha, Almonte, Maribel, Wentzensen, Nicolas, and Poljak, Mario

Abstract

While HC2 and GP5+/6+ PCR-EIA were pivotal in test validation of new HPV assays, they represent the first generation of comparator tests based upon technologies that are not in widespread use anymore. In the current guideline, criteria for second-generation comparator tests are presented that include more detailed resolution of HPV genotypes. Second-generation comparator tests should preferentially target only the 12 genotypes classified as carcinogenic (IARC-group I), and show consistent non-inferior sensitivity for CIN2+ and CIN3+ and specificity for ≤CIN1 compared to one of the first-generations comparators, in at least three validation studies using benchmarks of 0.95 for relative sensitivity and 0.98 for relative specificity. Validation should take into account used storage media and other sample handling procedures. Meta-analyses were conducted to identify the assays that fulfill these stringent criteria. Four tests fulfilled the new criteria: (1) RealTime High-Risk HPV Test (Abbott), (2) Cobas-4800 HPV test (Roche Molecular System), (3) Onclarity HPV Assay (BD Diagnostics), and (4) Anyplex II HPV HR Detection (Seegene), each evaluated in three to six studies. Whereas the four assays target 14 carcinogenic genotypes, the first two identify separately HPV16 and 18, the third assay identifies five types separately and the fourth identifies all the types separately.

Published
2024

23. Clinical performance of the novel full-genotyping OncoPredict HPV Quantitative Typing assay using the VALGENT framework

Author

Cocuzza, C, Dhillon, S, Martinelli, M, Giubbi, C, Njoku, R, Bhatia, R, Cuschieri, K, Arbyn, M, Cocuzza, Clementina Elvezia, Dhillon, Sharonjit Kaur, Martinelli, Marianna, Giubbi, Chiara, Njoku, Ruth Chinyere, Bhatia, Ramya, Cuschieri, Kate, Arbyn, Marc, Cocuzza, C, Dhillon, S, Martinelli, M, Giubbi, C, Njoku, R, Bhatia, R, Cuschieri, K, Arbyn, M, Cocuzza, Clementina Elvezia, Dhillon, Sharonjit Kaur, Martinelli, Marianna, Giubbi, Chiara, Njoku, Ruth Chinyere, Bhatia, Ramya, Cuschieri, Kate, and Arbyn, Marc

Abstract

Clinical validation of human papillomavirus (HPV) assays according to international criteria is prerequisite for their implementation in cervical cancer screening. OncoPredict HPV Quantitative Typing (QT) assay (Hiantis Srl, Milan, Italy) is a novel full-genotyping multiplex real-time PCR quantitative assay targeting E6/E7 genes, allowing individual viral load determination of 12 high-risk (HR) HPV types. Quality controls for sample adequacy, efficiency of nucleic acid extraction and PCR inhibition are included in the assay. Clinical performance of OncoPredict HPV QT test was assessed as part of the “Validation of HPV Genotyping Tests” (VALGENT-2) framework, consisting of 1300 cervical liquid-based cytology (LBC) samples of women aged between 20 and 60 years who had originally attended for routine cervical screening in Scotland. The clinical accuracy of the OncoPredict HPV QT (index test) for the detection of CIN2+ was assessed relative to the GP5+/6+ Enzyme ImmunoAssay (GP5+/6+ EIA) (comparator test), using noninferiority criteria. Intra- and interlaboratory reproducibility of the assay was assessed on a subpopulation, comprising 526 samples. The relative sensitivity and specificity for OncoPredict HPV QT vs GP5+/6+-PCR-EIA were 1.01 (95% CI: 0.99-1.03) and 1.03 (95% CI: 1.0-1.06) respectively. The P-values for noninferiority were ≤0.001. The intra- and inter-laboratory reproducibility demonstrated a high concordance (>98.7%) with kappas for individual types ranging from 0.66 to 1.00. OncoPredict HPV QT fulfills the international validation criteria for the use of HPV tests in cervical cancer screening.

Published
2024

24. Criteria for second generation comparator tests in validation of novel HPV DNA tests for use in cervical cancer screening.

Author

Arbyn, Marc, Cuschieri, Kate, Bonde, Jesper, Schuurman, Rob, Cocuzza, Clementina, Broeck, Davy Vanden, Zhao, Fang‐Hui, Rezhake, Remila, Gultekin, Murat, de Sanjosé, Silvia, Canfell, Karen, Hawkes, David, Saville, Marion, Hillemanns, Peter, Dillner, Joakim, Berkhof, Johannes, Prétet, Jean‐Luc, Gheit, Tarik, Clifford, Gary, and Basu, Partha

Subjects
EARLY detection of cancer, HUMAN papillomavirus, SAMPLING (Process), CERVICAL cancer, COMPARATOR circuits
Abstract

While HC2 and GP5+/6+ PCR‐EIA were pivotal in test validation of new HPV assays, they represent the first generation of comparator tests based upon technologies that are not in widespread use anymore. In the current guideline, criteria for second‐generation comparator tests are presented that include more detailed resolution of HPV genotypes. Second‐generation comparator tests should preferentially target only the 12 genotypes classified as carcinogenic (IARC‐group I), and show consistent non‐inferior sensitivity for CIN2+ and CIN3+ and specificity for ≤CIN1 compared to one of the first‐generations comparators, in at least three validation studies using benchmarks of 0.95 for relative sensitivity and 0.98 for relative specificity. Validation should take into account used storage media and other sample handling procedures. Meta‐analyses were conducted to identify the assays that fulfill these stringent criteria. Four tests fulfilled the new criteria: (1) RealTime High‐Risk HPV Test (Abbott), (2) Cobas‐4800 HPV test (Roche Molecular System), (3) Onclarity HPV Assay (BD Diagnostics), and (4) Anyplex II HPV HR Detection (Seegene), each evaluated in three to six studies. Whereas the four assays target 14 carcinogenic genotypes, the first two identify separately HPV16 and 18, the third assay identifies five types separately and the fourth identifies all the types separately. [ABSTRACT FROM AUTHOR]

Published
2024
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29. List of Contributors

Author

Alemany, Laia, primary, Arbyn, Marc, additional, Beeravolu, Harshita, additional, Bergeron, Christine, additional, Berkhof, Johannes, additional, Bhatla, Neerja, additional, Bosch, F. Xavier, additional, Broker, Thomas R., additional, Bruni, Laia, additional, Canarte, Veronica, additional, Canfell, Karen, additional, Corcoran, Brenda, additional, Cubie, Heather, additional, Cuschieri, Kate, additional, Cuzick, J., additional, Denny, Lynette, additional, Doorbar, John, additional, Dutta, Tapati, additional, Fakhry, Carole, additional, Faraji, Farhoud, additional, Forster, Alice, additional, Franceschi, Silva, additional, Franco, Eduardo L., additional, Garland, Suzanne M., additional, Geraets, Daan, additional, Giuliano, Anna R., additional, Grace, Miranda, additional, Guimera, Nuria, additional, Hanley, Sharon, additional, Heideman, D.A.M., additional, Jenkins, David, additional, Joura, Elmar, additional, Kremer, W.W., additional, Lacey, Charles J.N., additional, Leeman, Annemiek, additional, Lorincz, Attila, additional, Markowitz, Lauri E., additional, Meijer, Chris J.L.M., additional, Meyerson, Beth E., additional, Moscicki, Anna-Barbara, additional, Munger, Karl, additional, Muñoz, Nubia, additional, Paavonen, Jorma, additional, Palefsky, Joel M., additional, Pollock, Kevin G., additional, Quint, Wim, additional, Ronco, G., additional, Schiffman, Mark, additional, Sharma, Surendra, additional, Singer, Albert, additional, Stanley, Margaret, additional, Stoler, Mark H., additional, von Knebel Doeberitz, Magnus, additional, Wheeler, Cosette Marie, additional, Wu, Sharon C., additional, and Zimet, Gregory D., additional

Published
2020
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40. Clinical performance of the novel full‐genotyping OncoPredict HPV Quantitative Typing assay using the VALGENT framework.

Author

Cocuzza, Clementina Elvezia, Dhillon, Sharonjit Kaur, Martinelli, Marianna, Giubbi, Chiara, Njoku, Ruth Chinyere, Bhatia, Ramya, Cuschieri, Kate, and Arbyn, Marc

Subjects
HUMAN papillomavirus, EARLY detection of cancer, ENZYME-linked immunosorbent assay, VIRAL load, CERVICAL cancer
Abstract

Clinical validation of human papillomavirus (HPV) assays according to international criteria is prerequisite for their implementation in cervical cancer screening. OncoPredict HPV Quantitative Typing (QT) assay (Hiantis Srl, Milan, Italy) is a novel full‐genotyping multiplex real‐time PCR quantitative assay targeting E6/E7 genes, allowing individual viral load determination of 12 high‐risk (HR) HPV types. Quality controls for sample adequacy, efficiency of nucleic acid extraction and PCR inhibition are included in the assay. Clinical performance of OncoPredict HPV QT test was assessed as part of the "Validation of HPV Genotyping Tests" (VALGENT‐2) framework, consisting of 1300 cervical liquid‐based cytology (LBC) samples of women aged between 20 and 60 years who had originally attended for routine cervical screening in Scotland. The clinical accuracy of the OncoPredict HPV QT (index test) for the detection of CIN2+ was assessed relative to the GP5+/6+ Enzyme ImmunoAssay (GP5+/6+ EIA) (comparator test), using noninferiority criteria. Intra‐ and interlaboratory reproducibility of the assay was assessed on a subpopulation, comprising 526 samples. The relative sensitivity and specificity for OncoPredict HPV QT vs GP5+/6+‐PCR‐EIA were 1.01 (95% CI: 0.99‐1.03) and 1.03 (95% CI: 1.0‐1.06) respectively. The P‐values for noninferiority were ≤0.001. The intra‐ and inter‐laboratory reproducibility demonstrated a high concordance (>98.7%) with kappas for individual types ranging from 0.66 to 1.00. OncoPredict HPV QT fulfills the international validation criteria for the use of HPV tests in cervical cancer screening. [ABSTRACT FROM AUTHOR]

Published
2024
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42. Diversity of cervicovaginal human papillomavirus (HPV) genotypes and naturally occurring E6/E7 DNA polymorphisms of HPV-16 in Ghana

Author

Kaba, Gladys, primary, Stevenson, Andrew, additional, Sakyi, Samuel Asamoah, additional, Konney, Thomas Okpoti, additional, Bhatia, Ramya, additional, Titiloye, Nicolas A., additional, Oppong, Samuel A., additional, Agyemang-Yeboah, Francis, additional, Cuschieri, Kate, additional, and Graham, Sheila V., additional

Published
2023
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43. Evaluation of the clinical performance of OncoPredict HPV® SCR assay within the VALGENT-2 framework

Author

Dhillon, S, Cocuzza, C, Chung, P, Martinelli, M, Giubbi, C, Njoku, R, Bhatia, R, Cuschieri, K, Arbyn, M, Dhillon, Sharonjit K, Cocuzza, Clementina E, Chung, Pui Yan Jenny, Martinelli, Marianna, Giubbi, Chiara, Njoku, Ruth C, Bhatia, Ramya, Cuschieri, Kate, Arbyn, Marc, Dhillon, S, Cocuzza, C, Chung, P, Martinelli, M, Giubbi, C, Njoku, R, Bhatia, R, Cuschieri, K, Arbyn, M, Dhillon, Sharonjit K, Cocuzza, Clementina E, Chung, Pui Yan Jenny, Martinelli, Marianna, Giubbi, Chiara, Njoku, Ruth C, Bhatia, Ramya, Cuschieri, Kate, and Arbyn, Marc

Abstract

Human papillomavirus (HPV) assays used in cervical cancer screening should be clinically validated according to international criteria. OncoPredict HPV® Screening (SCR) is a partial genotyping multiplex real-time PCR assay targeting E6/E7 genes of 13 high-risk (hr) HPVs. OncoPredict HPV® SCR (index assay) identifies HPV-16 and HPV-18 separately, 11 other hrHPV in aggregate and includes quality controls for sample adequacy, DNA extraction efficiency and PCR inhibition. 1300 VALGENT-2 study samples (from women aged 20–60 attending the Scottish cervical cancer screening program) were tested with the index assay and the GP5+/6+ PCR enzyme immunoassay (standard comparator assay). Non-inferior accuracy detecting cervical intraepithelial neoplasia of grade 2 or worse (CIN2+) of the index versus comparator was verified. Intra- and interlaboratory reproducibility of the index was evaluated by overall concordance and Cohen's kappa, using a sub-population (n = 526). Relative sensitivity and specificity for CIN2+ of the index versus comparator were 1.01 (95% confidence interval [CI]: 0.99–1.03) and 1.02 (95% CI: 1.0–1.04), respectively. Noninferiority p values were all ≤0.05, except for CIN3+ in patients ≥30 years. Excellent intra- and interlaboratory reproducibility was shown with concordance >98% and kappas >0.95. OncoPredict HPV® SCR fulfills the three international validation criteria for hrHPV DNA tests in cervical cancer screening.

Published
2023

44. Data from HPV-Related Oropharynx Cancer in the United Kingdom: An Evolution in the Understanding of Disease Etiology

Author

Schache, Andrew G., primary, Powell, Ned G., primary, Cuschieri, Kate S., primary, Robinson, Max, primary, Leary, Sam, primary, Mehanna, Hisham, primary, Rapozo, Davy, primary, Long, Anna, primary, Cubie, Heather, primary, Junor, Elizabeth, primary, Monaghan, Hannah, primary, Harrington, Kevin J., primary, Nutting, Christopher M., primary, Schick, Ulrike, primary, Lau, Andy S., primary, Upile, Navdeep, primary, Sheard, Jon, primary, Brougham, Kath, primary, West, Catharine M.L., primary, Oguejiofor, Ken, primary, Thomas, Steve, primary, Ness, Andy R., primary, Pring, Miranda, primary, Thomas, Gareth J., primary, King, Emma V., primary, McCance, Dennis J., primary, James, Jacqueline A., primary, Moran, Michael, primary, Sloan, Phil, primary, Shaw, Richard J., primary, Evans, Mererid, primary, and Jones, Terry M., primary

Published
2023
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47. Human Papillomavirus Negative High Grade Cervical Lesions and Cancers: Suggested Guidance for Hpv Testing Quality Assurance

Author

Pretét, Jean Luc, primary, Mühr, Laila Sara Arroyo, additional, Cuschieri, Kate, additional, Fellner, María Dolores, additional, Correa, Rita Mariel, additional, Picconi, María Alejandra, additional, Garland, Suzanne Marie, additional, Murray, Gerald L., additional, Molano, Monica, additional, Peeters, Michael, additional, Van Gucht, Steven, additional, Lambrecht, Charlotte, additional, Vanden Broeck, Davy, additional, Padalko, Elizaveta, additional, Arbyn, Marc, additional, Lepiller, Quentin, additional, Brunier, Alice, additional, Silling, Steffi, additional, Søreng, Kristiane, additional, Christiansen, Irene Kraus, additional, Poljak, Mario, additional, Lagheden, Camilla, additional, Yilmaz, Emel, additional, Eklund, Carina, additional, Thapa, Hem R., additional, Querec, Troy D., additional, Unger, Elizabeth R., additional, and Dillner, Joakim, additional

Published
2023
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