Show simple item record

dc.contributor.authorIftner, Ten_US
dc.contributor.authorNeis, K-Jen_US
dc.contributor.authorCastanon, Aen_US
dc.contributor.authorLandy, Ren_US
dc.contributor.authorHolz, Ben_US
dc.contributor.authorWoll-Herrmann, Aen_US
dc.contributor.authorIftner, Aen_US
dc.contributor.authorStaebler, Aen_US
dc.contributor.authorWallwiener, Den_US
dc.contributor.authorHann von Weyhern, Cen_US
dc.contributor.authorNeis, Fen_US
dc.contributor.authorHaedicke-Jarboui, Jen_US
dc.contributor.authorMartus, Pen_US
dc.contributor.authorBrucker, Sen_US
dc.contributor.authorHenes, Men_US
dc.contributor.authorSasieni, Pen_US
dc.date.accessioned2018-12-03T15:45:03Z
dc.date.available2018-10-08en_US
dc.date.issued2019-01en_US
dc.date.submitted2018-11-25T02:38:35.565Z
dc.identifier.urihttp://qmro.qmul.ac.uk/xmlui/handle/123456789/53473
dc.description.abstractLongitudinal data on the E6/E7 mRNA-based Aptima human papillomavirus (AHPV) assay exceeding three years in comparison to the gold standard Digene Hybrid Capture 2 (HC2) test are not available. We previously reported the cross-sectional data of the German AHPV Screening Trial (GAST) in which 10,040 women were recruited and tested by liquid-based cytology, the HC2 assay, and the AHPV assay. Four hundred eleven test-positive women were followed for up to six years. In addition, 3,295 triple-negative women were screened after a median time of six years. Overall, 28 high-grade cervical intraepithelial neoplasia (CIN3) cases were detected. The absolute risk of developing high-risk HPV-positive CIN3+ over six years among those women that tested negative at baseline was 2.2 (95% confidence interval [95% CI], 1.0 to 4.9) and 3.1 (95% CI, 1.7 to 5.7) per 1,000 women screened by the HC2 and the AHPV tests; the additional risk for those with AHPV-negative compared with HC2-negative results was 0.9 (95% CI, -0.2 to 2.1) per 1,000. In comparison, the absolute risk following a negative LBC test was 9.3 (95% CI, 2.9 to 30.2). The relative sensitivity of AHPV compared to HC2 was 91.5% for CIN3+, and the negative predictive values were 99.8% (95% CI, 99.5 to 99.9%) for HC2 and 99.7% (95% CI, 99.4 to 99.8%) for AHPV. Our data show that the longitudinal performance of the AHPV test over six years is comparable to the performance of the HC2 test and that the absolute risk of CIN3+ over six years following a negative AHPV result in a screening population is low. (This study is registered at ClinicalTrials.gov under registration number NCT02634190.).en_US
dc.description.sponsorshipHologic Inc; Cancer Research UK grant A16892 to PS.en_US
dc.languageengen_US
dc.language.isoenen_US
dc.relation.ispartofJ Clin Microbiolen_US
dc.rightsThis is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license.
dc.subjectAptima HPVen_US
dc.subjectE6/E7 mRNAen_US
dc.subjectcervical cancer screeningen_US
dc.subjectcervical intraepithelial neoplasiaen_US
dc.titleLongitudinal Clinical Performance of the RNA-Based Aptima Human Papillomavirus (AHPV) Assay in Comparison to the DNA-Based Hybrid Capture 2 HPV Test in Two Consecutive Screening Rounds with a 6-Year Interval in Germany.en_US
dc.typeArticle
dc.rights.holder© 2018 Iftner et al.
dc.identifier.doi10.1128/JCM.01177-18en_US
pubs.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/30355760en_US
pubs.issue1en_US
pubs.notesNot knownen_US
pubs.publication-statusPublished onlineen_US
pubs.volume57en_US
dcterms.dateAccepted2018-10-08en_US


Files in this item

FilesSizeFormatView

There are no files associated with this item.

This item appears in the following Collection(s)

Show simple item record