TY - JOUR
T1 - HPV testing for primary cervical screening
T2 - Laboratory issues and evolving requirements for robust quality assurance
AU - Carozzi, Francesca Maria
AU - Del Mistro, Annarosa
AU - Cuschieri, Kate
AU - Frayle, Helena
AU - Sani, Cristina
AU - Burroni, Elena
PY - 2016/3/1
Y1 - 2016/3/1
N2 - 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.
AB - 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.
KW - Cervical cancer screening
KW - HPV DNA testing
KW - HPV EQA
KW - HPV IQA
KW - Quality assurance
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U2 - 10.1016/j.jcv.2015.10.025
DO - 10.1016/j.jcv.2015.10.025
M3 - Article
AN - SCOPUS:84960446102
VL - 76
SP - S22-S28
JO - Journal of Clinical Virology
JF - Journal of Clinical Virology
SN - 1386-6532
ER -