VALGENT: a protocol for clinical validation of human papillomavirus assays

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Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis

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Which high-risk HPV assays fulfil criteria for use in primary cervical cancer screening?

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Are 20 human papillomavirus types causing cervical cancer?

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Disagreement between human papillomavirus assays: an unexpected challenge for the choice of an assay in primary cervical screening

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Reliability of the Xpert HPV Assay to Detect High-Risk Human Papillomavirus DNA in a Colposcopy Referral Population

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Clinical and Analytical Performance of the Onclarity HPV Assay Using the VALGENT Framework

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Prevalence and viral load of 51 genital human papillomavirus types and three subtypes

Schmitt, M., Depuydt, C., Benoy, I. H., Bogers, J., Antoine, J., Arbyn, M., Pawlita, M., & on behalf of the VALGENT Study Group (2012) · International Journal of Cancer · doi:10.1002/ijc.27891 · Cited by 59 · see citing works

Clinical Validation of a Type-Specific Real-Time Quantitative Human Papillomavirus PCR against the Performance of Hybrid Capture 2 for the Purpose of Cervical Cancer Screening

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Viral Load of High-Risk Human Papillomaviruses as Reliable Clinical Predictor for the Presence of Cervical Lesions

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Comparison of the Clinical Performance of PapilloCheck Human Papillomavirus Detection with That of the GP5+/6+-PCR-Enzyme Immunoassay in Population-Based Cervical Screening

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Clinical Evaluation of a GP5+/6+-Based Luminex Assay Having Full High-Risk Human Papillomavirus Genotyping Capability and an Internal Control

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Cervical Cytology Biobanks as a Resource for Molecular Epidemiology

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Clinical Validation of the BD Onclarity? HPV Assay Using a Non-Inferiority Test

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Highlights of the 27th International Papillomavirus Conference and Clinical Workshop: Part 2: Applied Clinical Science

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Highlights of the 27th International Papillomavirus Conference and Clinical Workshop: part 1

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Access to pathology and laboratory medicine services: a crucial gap

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Primary HPV-based cervical cancer screening in Europe: implementation status, challenges, and future plans

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2020 list of human papillomavirus assays suitable for primary cervical cancer screening

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Cervical Cancer Screening Programs in Europe: The Transition Towards HPV Vaccination and Population-Based HPV Testing

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Clinical Utility of Human Papillomavirus Genotyping in Cervical Cancer Screening: A Systematic Review.

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Commercially available molecular tests for human papillomaviruses: a global overview

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Commercially available molecular tests for human papillomaviruses (HPV): 2015 update

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VALHUDES: A protocol for validation of human papillomavirus assays and collection devices for HPV testing on self-samples and urine samples

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Updates on cervical cancer prevention

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Self-Collection for Cervical Screening Programs: From Research to Reality

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Cervical cancer screening – The challenges of complete pathways of care in low-income countries: Focus on Malawi

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Cervical Cancer Screening Postpandemic: Self-Sampling Opportunities to Accelerate the Elimination of Cervical Cancer

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Human Papillomavirus Same Genotype Persistence and Risk: A Systematic Review

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Meta‐analysis of the accuracy of p16 or p16/Ki‐67 immunocytochemistry versus HPV testing for the detection of CIN2+/CIN3+ in triage of women with minor abnormal cytology

Peeters, E., Wentzensen, N., Bergeron, C., & Arbyn, M. (2019) · Cancer Cytopathology · doi:10.1002/cncy.22103 · Cited by 60 · see citing works

HPV testing in the context of post-treatment follow up (test of cure)

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Oral and laryngeal HPV infection: Incidence, prevalence and risk factors, with special regard to concurrent infection in head, neck and genitals

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Performance of a Cartridge-Based Assay for Detection of Clinically Significant Human Papillomavirus (HPV) Infection: Lessons from VALGENT (Validation of HPV Genotyping Tests)

Cuschieri, K., Geraets, D., Cuzick, J., Cadman, L., Moore, C., Vanden Broeck, D., Padalko, E., Quint, W., & Arbyn, M. (2016) · Journal of Clinical Microbiology · doi:10.1128/jcm.00897-16 · Cited by 55 · see citing works

Age-specific HPV prevalence among 116,052 women in Australia’s renewed cervical screening program: A new tool for monitoring vaccine impact

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Defining Optimal Triage Strategies for hrHPV Screen–Positive Women—An Evaluation of HPV 16/18 Genotyping, Cytology, and p16/Ki-67 Cytoimmunochemistry

Stanczuk, G. A., Baxter, G., Currie, H. D., Forson, W., LAWRENCE, J. R., Cuschieri, K. S., Wilson, A., Patterson, L., Govan, L., Black, J., et al. (2017) · Cancer Epidemiology Biomarkers & Prevention · doi:10.1158/1055-9965.epi-17-0534 · Cited by 51 · see citing works

Advanced technologies towards improved HPV diagnostics

Bartošík, M., Moráňová, L., Izadi, N., Strmisková, J., Sebuyoya, R., Holčáková, J., & Hrstka, R. (2024) · Journal of Medical Virology · doi:10.1002/jmv.29409 · Cited by 52 · see citing works

Risk stratification for cervical neoplasia using extended high‐risk HPV genotyping in women with ASC‐US cytology: A large retrospective study from China

Tao, X., Austin, R. M., Yu, T. C., Zhong, F., Zhou, X., Cong, Q., Sui, L., & Zhao, C. (2021) · Cancer Cytopathology · doi:10.1002/cncy.22536 · Cited by 45 · see citing works

Assessment of the Roche Linear Array HPV Genotyping Test within the VALGENT framework

Xu, L., Oštrbenk, A., Poljak, M., & Arbyn, M. (2018) · Journal of Clinical Virology · doi:10.1016/j.jcv.2017.12.001 · Cited by 45 · see citing works

The Valgent4 protocol: Robust analytical and clinical validation of 11 HPV assays with genotyping on cervical samples collected in SurePath medium.

Bonde, J., Ejegod, D. M., Cuschieri, K., Dillner, J., Heideman, D. A. M., Quint, W., Pavon Ribas, M. A., Padalko, E., Christiansen, I. K., Xu, L., et al. (2018) · Journal of Clinical Virology · doi:10.1016/j.jcv.2018.09.012 · Cited by 44 · see citing works

Infecciones genitales por el virus del papiloma humano

Sendagorta‐Cudós, E., Burgos, J., & Rodríguez‐Iglesias, M. (2019) · Enfermedades Infecciosas y Microbiología Clínica · doi:10.1016/j.eimc.2019.01.010 · Cited by 44 · see citing works

Comparison of Two Widely Used Human Papillomavirus Detection and Genotyping Methods, GP5+/6+-Based PCR Followed by Reverse Line Blot Hybridization and Multiplex Type-Specific E7-Based PCR

Clifford, G. M., Vaccarella, S., Franceschi, S., Tenet, V., Umulisa, M. C., Tshomo, U., Dondog, B., Vorsters, A., Tommasino, M., Heideman, D. A. M., et al. (2016) · Journal of Clinical Microbiology · doi:10.1128/jcm.00618-16 · Cited by 43 · see citing works

HPV-based Cervical Cancer Screening on Self-samples in the Netherlands: Challenges to Reach Women and Test Performance Questions

Arbyn, M., Costa, S., Latsuzbaia, A., Kellen, E., Rossi, P. G., Cocuzza, C. E., Basu, P. S., & Castle, P. E. (2023) · Cancer Epidemiology Biomarkers & Prevention · doi:10.1158/1055-9965.epi-22-1041 · Cited by 41 · see citing works

2023 global inventory of commercial molecular tests for human papillomaviruses (HPV)

Poljak, M., Oštrbenk, A., Cuschieri, K. S., Bohinc, K. B., & Arbyn, M. (2024) · Journal of Clinical Virology · doi:10.1016/j.jcv.2024.105671 · Cited by 41 · see citing works

A novel sequencing-based vaginal health assay combining self-sampling, HPV detection and genotyping, STI detection, and vaginal microbiome analysis

Bik, E. M., Bird, S. W., Bustamante, J. P., León, L. E., Nieto, P. A., Addae, K., Alegría-Mera, V., Bravo, C., Bravo, D., Cárdenas, J. P., et al. (2019) · PLoS ONE · doi:10.1371/journal.pone.0215945 · Cited by 40 · see citing works

Human Papillomavirus E6 biosensing: Current progression on early detection strategies for cervical Cancer

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Accuracy of Human Papillomavirus (HPV) Testing on Urine and Vaginal Self-Samples Compared to Clinician-Collected Cervical Sample in Women Referred to Colposcopy

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Clinical Evaluation of INNO-LiPA HPV Genotyping EXTRA II Assay Using the VALGENT Framework

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Clinical and Analytical Performance of the BD Onclarity HPV Assay with SurePath Screening Samples from the Danish Cervical Screening Program Using the VALGENT Framework

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Methodologies of Primary HPV Testing Currently Applied for Cervical Cancer Screening

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Bayesian analysis of baseline risk of CIN2 and ≥CIN3 by HPV genotype in a European referral cohort

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

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Validation of a Human Papillomavirus (HPV) DNA Cervical Screening Test That Provides Expanded HPV Typing

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Clinical Performance of the RealTi m e High Risk HPV Assay on Self-Collected Vaginal Samples within the VALHUDES Framework

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Alinity m HR HPV Assay Fulfills Criteria for Human Papillomavirus Test Requirements in Cervical Cancer Screening Settings

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Characterization and Diversity of 243 Complete Human Papillomavirus Genomes in Cervical Swabs Using Next Generation Sequencing

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Human Papillomavirus Genotyping Compared With a Qualitative High-Risk Human Papillomavirus Test After Treatment of High-Grade Cervical Intraepithelial Neoplasia

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HPV genotype-specific concordance between EuroArray HPV, Anyplex II HPV28 and Linear Array HPV Genotyping test in Australian cervical samples

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Using the VALGENT-3 framework to assess the clinical and analytical performance of the RIATOL qPCR HPV genotyping assay

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High rate of non-vaccine targeted high-risk HPV genotypes circulate among women in Eastern Ethiopia

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Clinical and Analytical Evaluation of the Alinity m HR HPV Assay within the VALGENT-3 Framework

Dhillon, S. K., Oštrbenk, A., Xu, L., Poljak, M., & Arbyn, M. (2021) · Journal of Clinical Microbiology · doi:10.1128/jcm.00286-21 · Cited by 21 · see citing works

Evaluation of Human Papilloma Virus (HPV) Genotyping and Viral Load Determination as Diagnostic Biomarkers of Cervical Cancer Risk

Martinelli, M., Giubbi, C., Saderi, L., Musumeci, R., Perdoni, F., Leone, B. E., Fruscio, R., Landoni, F., Piana, A. F., Sotgiu, G., et al. (2023) · International Journal of Molecular Sciences · doi:10.3390/ijms24021320 · Cited by 21 · see citing works

HPV self-sampling among cervical cancer screening users in Spain: A randomized clinical trial of on-site training to increase the acceptability

Ibáñez, R., Roura, E., Acera, A., Andújar, M., Pavón, M. Á., Bruni, L., & de Sanjosé, S. (2023) · Preventive Medicine · doi:10.1016/j.ypmed.2023.107571 · Cited by 19 · see citing works

Comparison of the Clinical Accuracy of Xpert HPV Assay on Vaginal Self-Samples and Cervical Clinician-Taken Samples within the VALHUDES Framework

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

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A Head-to-Head Analytical Comparison of Cobas 4800 HPV, PapilloCheck HPV Screening, and LMNX Genotyping Kit HPV GP for Detection of Human Papillomavirus DNA in Cervical and Cervicovaginal Swabs

Jaworek, H., Koudeláková, V., Drábek, J., Vrbková, J., Zbořilová, B., Oborná, I., Brezinova, J., Marek, R., Huml, K., Vaněk, P., et al. (2018) · Journal of Molecular Diagnostics · doi:10.1016/j.jmoldx.2018.07.004 · Cited by 16 · see citing works

Human papillomavirus E7 protein detection as a method of triage to colposcopy of HPV positive women, in comparison to genotyping and cytology. Final results of the PIPAVIR study

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Evaluation and Optimization of the Clinical Accuracy of Hybribio's 14 High-Risk HPV with 16/18 Genotyping Assay within the VALGENT-3 Framework

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Clinical validation of the Cobas 4800 HPV assay using cervical samples in SurePath medium under the VALGENT4 framework

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Clinical validation of REALQUALITY RQ-HPV Screen according to the international guidelines for human papillomavirus DNA test requirements for cervical screening

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Accuracy of genotyping for HPV16 and 18 to triage women with low-grade squamous intraepithelial lesions: a pooled analysis of VALGENT studies

Xu, L., Benoy, I. H., Cuschieri, K. S., Poljak, M., Bonde, J. H., & Arbyn, M. (2019) · Expert Review of Molecular Diagnostics · doi:10.1080/14737159.2019.1613890 · Cited by 15 · see citing works

Diagnostic accuracy of high-risk HPV DNA genotyping for primary cervical cancer screening and triage of HPV-positive women, compared to cytology: preliminary results of the PIPAVIR study

Chatzistamatiou, Κ., Moysiadis, T., Angelis, E., Kaufmann, A. M., Skenderi, A., Jansen‐Dürr, P., Lekka, I., Kilintzis, V., Angelidou, S., Katsiki, E., et al. (2017) · Archives of Gynecology and Obstetrics · doi:10.1007/s00404-017-4324-x · Cited by 16 · see citing works

Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelines for cervical cancer screening

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Clinical Performance of OncoPredict HPV Screening Assay on Self‐Collected Vaginal and Urine Specimens Within the VALHUDES Framework

Giubbi, C., Martinelli, M., Latsuzbaia, A., Cuschieri, K. S., Elasifer, H., Iacobone, A. D., Bottari, F., Piana, A. F., Pietri, R., Tisi, G., et al. (2024) · Journal of Medical Virology · doi:10.1002/jmv.70079 · Cited by 14 · see citing works

Implementing HPV testing in 9 Latin American countries: The laboratory perspective as observed in the ESTAMPA study

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Association of human papillomavirus genotype distribution and cervical cytology: a cross-sectional study

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HPV-based cervical cancer screening, including self-sampling, versus screening with cytology in Argentina

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Clinical accuracy of OncoPredict HPV Quantitative Typing (QT) assay on self-samples

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Reflections Regarding Validation of New HPV Tests With Reduced HPV Genotypes: Report From an IARC Expert Consultation

Ramírez, A. T., Clifford, G. M., Dillner, J., Kuhn, L., Arbyn, M., Bhatla, N., Wentzensen, N., Sasieni, P. D., Abraham, P., Rol, M. L., et al. (2025) · Journal of Medical Virology · doi:10.1002/jmv.70310 · Cited by 10 · see citing works

Analytical and Clinical Sample Performance Characteristics of the Onclarity Assay for the Detection of Human Papillomavirus

Young, S. A., Vaughan, L. M., Yanson, K. A., Eckert, K., Li, A., Harris, J., Ermel, A. C., Williams, J. A., Al-Ghoul, M., Cammarata, C. L., et al. (2020) · Journal of Clinical Microbiology · doi:10.1128/jcm.02048-20 · Cited by 12 · see citing works

The Positive Predictive Value of High-Grade Squamous Intraepithelial Lesion on Cytology for the Histological Diagnosis of Cervical Intraepithelial Neoplasia 2 or Higher: A Systematic Review

Karia, N., Loon, A. V., Simoens, C., Benoy, I. H., & Bogers, J. (2019) · Acta Cytologica · doi:10.1159/000497110 · Cited by 12 · see citing works

Cost-Effectiveness Analysis of HPV Extended versus Partial Genotyping for Cervical Cancer Screening in Singapore

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Nouvelles recommandations pour le dépistage du cancer du col de l’utérus en France

Baraquin, A., Pépin‐Puget, L., Floerchinger, P., Lepiller, Q., & Prétet, J. (2022) · Annales Pharmaceutiques Françaises · doi:10.1016/j.pharma.2022.09.006 · Cited by 11 · see citing works

Assessment of the clinical and analytical performance of the Aptima SARS-CoV-2 assay using the VALCOR protocol

Dhillon, S. K., Simoens, C., Cuypers, L., Bode, J., Bonde, J. H., Corbisier, P., Cocuzza, C. E., Ranst, M. A. V., & Arbyn, M. (2023) · Virology Journal · doi:10.1186/s12985-023-01986-4 · Cited by 10 · see citing works

Clinical performance of the HPV-Risk assay on cervical samples in SurePath medium using the VALGENT-4 panel

Heideman, D. A. M., Xu, L., Hesselink, A. T., van Doorn, S. V. W., Ejegod, D. M., Pedersen, H., Quint, W. G. V., Bonde, J. H., & Arbyn, M. (2019) · Journal of Clinical Virology · doi:10.1016/j.jcv.2019.104201 · Cited by 10 · see citing works

Prevention and control of HPV and HPV-related cancers in France: the evolving landscape and the way forward – a meeting report

Waheed, D.-E.-N., Weil-Olivier, C., Riethmuller, D., Franco, E. L., Prétet, J., Baay, M. F. D., Muñóz, N., & Vorsters, A. (2023) · BMC Proceedings · doi:10.1186/s12919-023-00271-0 · Cited by 10 · see citing works

Ensuring quality in cervical screening programmes based on molecular human papillomavirus testing

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Comparison of the Cepheid Xpert HPV test and the HC2 High-Risk HPV DNA Test for detection of high-risk HPV infection in cervical smear samples in SurePath preservative fluid

Rabaan, A. A., Alfaraj, S. A., & Alkhalifah, M. A. (2018) · Journal of Medical Microbiology · doi:10.1099/jmm.0.000723 · Cited by 10 · see citing works

Comparative evaluation of Allplex HPV28 and Anyplex II HPV28 assays for high-risk HPV genotyping in cervical samples

Mafi, S., Theuillon, F., Meyer, S., Woillard, J.-B., Dupont, M., Rogez, S., Alain, S., & Hantz, S. (2025) · PLOS ONE · doi:10.1371/journal.pone.0320978 · Cited by 9 · see citing works

Clinical Validation of the Onclarity Assay After Assay Migration to the High-Throughput COR Instrument Using SurePath Screening Samples From the Danish Cervical Cancer Screening Program

Ejegod, D. M., Pedersen, H., Pedersen, B. T., Jonassen, C. M., Lie, A. K., Hulleberg, L. S., Arbyn, M., & Bonde, J. H. (2021) · American Journal of Clinical Pathology · doi:10.1093/ajcp/aqab138 · Cited by 9 · see citing works

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

Cocuzza, C. E., Dhillon, S. K., Martinelli, M., Giubbi, C., Njoku, R. C., Bhatia, R., Cuschieri, K. S., & Arbyn, M. (2023) · International Journal of Cancer · doi:10.1002/ijc.34754 · Cited by 8 · see citing works

Profile of MeltPro® HPV test for human papillomavirus genotyping and cervical precancer screening

Liao, Y., & Li, Q. (2019) · Expert Review of Molecular Diagnostics · doi:10.1080/14737159.2019.1662299 · Cited by 8 · see citing works

Comparison of the clinical and analytical performance of Alinity m HR HPV and cobas 4800 HPV assays in a population-based screening setting

Oštrbenk, A., Bertram, A., Gröning, A., & Poljak, M. (2021) · Journal of Clinical Virology · doi:10.1016/j.jcv.2021.104851 · Cited by 8 · see citing works

Evaluation of C-C Motif Chemokine Receptor 5 (CCR5) as a Sample Adequacy Control in HPV Molecular Diagnostics

Njoku, R. C., Martinelli, M., Giubbi, C., Marco, S. D., Torsello, B., d’Avenia, M., Sironi, M., Bianchi, C., & Cocuzza, C. E. (2024) · Diagnostics · doi:10.3390/diagnostics14192194 · Cited by 7 · see citing works

Evaluation of a Novel Single-Tube Method for Extended Genotyping of Human Papillomavirus

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Intra‐ and interlaboratory reproducibility of the RIATOL qPCR HPV genotyping assay

Dhillon, S. K., Chung, P. Y. J., Padalko, E. Y., Praet, M. M., Pereira, A. R., Redzic, N., Broeck, D. V., & Arbyn, M. (2023) · Journal of Medical Virology · doi:10.1002/jmv.29093 · Cited by 7 · see citing works

Evaluation of the Onclarity HPV assay on the high-throughput COR system

Taylor, S. N., Eckert, K., Rucki, A. A., VanSickler, M., Price, J. A., Gutierrez, E. C., Lizzi, M., Cammarata, C. L., von Bredow, B., Wolfe, D. M., et al. (2021) · Expert Review of Molecular Diagnostics · doi:10.1080/14737159.2021.1894132 · Cited by 7 · see citing works

ESCV Membership

(2016) · Journal of Clinical Virology · doi:10.1016/s1386-6532(16)00053-6

Performance of a Cartridge-Based Assay for Detection of Clinically Significant Human Papillomavirus (HPV) Infection: Lessons from VALGENT (Validation of HPV Genotyping Tests)

Cuschieri, K., Geraets, D., Cuzick, J., Cadman, L., Moore, C., Vanden Broeck, D., Padalko, E., Quint, W., & Arbyn, M. (2016) · Journal of Clinical Microbiology · doi:10.1128/jcm.00897-16 · Cited by 55 · see citing works

Clinical Validation of the Venus HPV Full‐Genotyping Assay for Cervical Cancer Screening in the VALGENT‐4 Framework

Xu, L., Ma, C., Cuschieri, K. S., Bonde, J. H., & Arbyn, M. (2025) · Journal of Medical Virology · doi:10.1002/jmv.70527

Clinical performance of the HPV-Risk assay on cervical samples in SurePath medium using the VALGENT-4 panel

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