Clinical validation of Anyplex? II HPV HR Detection according to the guidelines for HPV test requirements for cervical cancer screening.

Détails

Ressource 1Télécharger: BIB_E33FBC01BB21.P001.pdf (247.21 [Ko])
Etat: Public
Version: de l'auteur
ID Serval
serval:BIB_E33FBC01BB21
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Clinical validation of Anyplex? II HPV HR Detection according to the guidelines for HPV test requirements for cervical cancer screening.
Périodique
Journal of Clinical Virology
Auteur(s)
Hesselink A.T., Sahli R., Berkhof J., Snijders P.J., van der Salm M.L., Agard D., Bleeker M.C., Heideman D.A.
ISSN
1873-5967 (Electronic)
ISSN-L
1386-6532
Statut éditorial
Publié
Date de publication
2016
Peer-reviewed
Oui
Volume
76
Pages
36-39
Langue
anglais
Résumé
BACKGROUND: Anyplex? II HPV HR Detection (Seegene, Seoul, Korea) is a multiplex real-time PCR using tagging oligonucleotide cleavage and extension (TOCE) technology for simultaneous detection and genotyping of 14 high-risk (HR) HPV types, including HPV16 and HPV18.
OBJECTIVES: To evaluate whether the clinical performance and reproducibility of Anyplex? II HPV HR Detection meet the international consensus guidelines for HPV test requirements for cervical cancer screening [1].
STUDY DESIGN: The clinical performance of Anyplex? II HPV HR Detection for detecting cervical intraepithelial neoplasia grade 2 or worse (CIN2+) was determined relative to that of the reference assay, i.e., HR HPV GP5+/6+-PCR-EIA, by analysis of a total of 879 cervical liquid based cytology (LBC) specimens from a screening population, of which 60 were from women with CIN2+. The intra-laboratory reproducibility and inter-laboratory agreement were determined on 509 LBC samples, of which 172 were positive by the reference assay.
RESULTS: Anyplex? II HPV HR Detection showed a clinical sensitivity for CIN2+ of 98.3% (59/60; 95% CI: 89.1-99.8) and a clinical specificity for CIN2+ of 93.6% (764/816; 95% CI: 89.8-96.1). The clinical sensitivity and specificity were non-inferior to those of HR HPV GP5+/6+-PCR-EIA (non-inferiority score test: P=0.005 and P=0.023, respectively). Both intra-laboratory reproducibility (96.8%; 95% CI: 95.3-98.1; kappa value of 0.93) and inter-laboratory agreement (96.0%; 95% CI: 94.3-97.4; kappa value of 0.91) were high.
CONCLUSIONS: Anyplex? II HPV HR Detection performs clinically non-inferior to HR HPV GP5+/6+-PCR-EIA. Anyplex? II HPV HR Detection complies with international consensus validation metrics for HPV DNA tests for cervical cancer screening [1].
Pubmed
Web of science
Open Access
Oui
Création de la notice
05/04/2016 16:59
Dernière modification de la notice
20/08/2019 16:07
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