Clinical validation of the Abbott RealTime High Risk HPV assay according to the guidelines for human papillomavirus DNA test requirements for cervical screening

A T Hesselink; C J L M Meijer; M Poljak; J Berkhof; F J van Kemenade; M L van der Salm; M Bogaarts; P J F Snijders; D A M Heideman

doi:10.1128/JCM.00633-13

Clinical validation of the Abbott RealTime High Risk HPV assay according to the guidelines for human papillomavirus DNA test requirements for cervical screening

J Clin Microbiol. 2013 Jul;51(7):2409-10. doi: 10.1128/JCM.00633-13. Epub 2013 May 1.

Authors

A T Hesselink¹, C J L M Meijer, M Poljak, J Berkhof, F J van Kemenade, M L van der Salm, M Bogaarts, P J F Snijders, D A M Heideman

Affiliation

¹ Department of Pathology, VU University Medical Center, Amsterdam, The Netherlands.

Abstract

This study showed that the Abbott RealTime High Risk HPV assay fulfilled cross-sectional clinical equivalence and reproducibility criteria of international consensus guidelines, which indicates that this assay can be considered clinically validated for cervical cancer screening purposes.

Publication types

Research Support, Non-U.S. Gov't
Validation Study

MeSH terms

Adult
DNA, Viral / genetics
DNA, Viral / isolation & purification
Early Detection of Cancer / methods*
Female
Humans
Middle Aged
Molecular Diagnostic Techniques / methods*
Papillomaviridae / classification
Papillomaviridae / genetics*
Papillomaviridae / isolation & purification*
Papillomavirus Infections / diagnosis*
Papillomavirus Infections / virology
Real-Time Polymerase Chain Reaction / methods*
Reproducibility of Results
Virology / methods*

Substances

DNA, Viral