title: HPV testing for primary cervical screening: Laboratory issues and evolving requirements for robust quality assurance.
abstract: This review aims to highlight the importance of Quality Assurance for Laboratories performing HPV test for Cervical Cancer Screening. An HPV test, to be used as primary screening test, must be validated according to international criteria, based on comparison of its clinical accuracy to HC2 or GP5+/6+ PCR-EIA tests. The number of validated platforms is increasing and appropriate Quality Assurance Programs (QAPs) which can interrogate longitudinal robustness and quality are paramount. This document describes the following topics: (1) the characteristics of an HPV laboratory and the personnel training needs, to ensure an elevated quality of the entire process and the optimal use of the resources; (2) the Quality Assurance, as both internal (IQA) and external quality assessment (EQA) systems, to be implemented and performed, and the description of the existing EQAs, including limitations; (3) general considerations for an optimal EQA program for hrHPV primary screening Due to the importance of Quality Assurance for this field, international efforts are necessary to improve QA International Collaboration.
authors.affiliation: Cancer Research and Prevention Institute (ISPO), Cancer Prevention Laboratory, HPV Laboratory and Molecular Oncology Unit, Florence, Italy. Electronic address: f.arozzi@ispo.toscana.it.
authors.forename: Francesca Maria
authors.initials: FM
authors.lastname: Carozzi
authors.affiliation: Veneto Institute of Oncology (IOV-IRCCS), Diagnostic Molecular Oncology Unit, Padua, Italy.
authors.forename: Annarosa
authors.initials: A
authors.lastname: Del Mistro
authors.affiliation: Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh, EH164SA United Kingdom.
authors.forename: Kate
authors.initials: K
authors.lastname: Cuschieri
authors.affiliation: Veneto Institute of Oncology (IOV-IRCCS), Diagnostic Molecular Oncology Unit, Padua, Italy.
authors.forename: Helena
authors.initials: H
authors.lastname: Frayle
authors.affiliation: Cancer Research and Prevention Institute (ISPO), Cancer Prevention Laboratory, HPV Laboratory and Molecular Oncology Unit, Florence, Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Sani
authors.affiliation: Cancer Research and Prevention Institute (ISPO), Cancer Prevention Laboratory, HPV Laboratory and Molecular Oncology Unit, Florence, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Burroni
mesh_terms: D003954:Diagnostic Services; D055088:Early Detection of Cancer / Q000379:methods; D005260:Female; D060005:Genotyping Techniques; D061809:Human Papillomavirus DNA Tests / Q000592:standards; D006801:Humans; D007391:International Cooperation; D007753:Laboratories; D008403:Mass Screening; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000150:complications / Q000175:diagnosis* / Q000821:virology; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000592:standards; D002583:Uterine Cervical Neoplasms / Q000150:complications / Q000175:diagnosis* / Q000821:virology; D002578:Uterine Cervical Dysplasia / Q000150:complications / Q000175:diagnosis* / Q000821:virology
chemical_list: D011933:Reagent Kits, Diagnostic
keywords: Cervical cancer screening; HPV DNA testing; HPV EQA; HPV IQA; Quality assurance