VALGENT: A protocol for clinical validation of human papillomavirus assays

Highlights • Only clinically validated HPV tests should be used in cervical cancer screening. • VALGENT is a robust protocol for validation of hrHPV and HPV genotyping assays. • In VALGENT-2 sufficient clinical accuracy of three HPV assays was demonstrated. • VALGENT is producing a comprehensive stu...

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Veröffentlicht in:	Journal of clinical virology 2016-03, Vol.76, p.S14-S21
Hauptverfasser:	Arbyn, Marc, Depuydt, Christophe, Benoy, Ina, Bogers, Johannes, Cuschieri, Kate, Schmitt, Markus, Pawlita, Michael, Geraets, Daan, Heard, Isabelle, Gheit, Tarik, Tommasino, Massimo, Poljak, Mario, Bonde, Jesper, Quint, Wim
Format:	Artikel
Sprache:	eng
Schlagworte:	Adult Allergy and Immunology Cervical cancer Cervical cancer screening Diagnostic test accuracy Early Detection of Cancer - methods Female Genotyping Techniques Human papillomavirus Human Papillomavirus DNA Tests - standards Humans Infectious Disease Mass Screening Middle Aged Papillomaviridae - classification Papillomaviridae - genetics Papillomaviridae - isolation & purification Papillomavirus Infections - complications Papillomavirus Infections - diagnosis Papillomavirus Infections - virology Quality control Reagent Kits, Diagnostic - standards Reagent Kits, Diagnostic - supply & distribution Test validation Uterine Cervical Dysplasia - complications Uterine Cervical Dysplasia - diagnosis Uterine Cervical Dysplasia - virology Uterine Cervical Neoplasms - complications Uterine Cervical Neoplasms - diagnosis Uterine Cervical Neoplasms - virology Vaginal Smears Validation Studies as Topic
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Beschreibung
Zusammenfassung:	Highlights • Only clinically validated HPV tests should be used in cervical cancer screening. • VALGENT is a robust protocol for validation of hrHPV and HPV genotyping assays. • In VALGENT-2 sufficient clinical accuracy of three HPV assays was demonstrated. • VALGENT is producing a comprehensive study resource for HPV test comparisons. • Integration of VALGENT into the global WHO reference laboratory network is planned.
ISSN:	1386-6532 1873-5967
DOI:	10.1016/j.jcv.2015.09.014