<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Sharon Dhillon</style></author><author><style face="normal" font="default" size="100%">Clementina E. Cocuzza</style></author><author><style face="normal" font="default" size="100%">Jenny Pui Yan Chung</style></author><author><style face="normal" font="default" size="100%">Marianna Martinelli</style></author><author><style face="normal" font="default" size="100%">Chiara Giubbi</style></author><author><style face="normal" font="default" size="100%">Ruth C. Njoku</style></author><author><style face="normal" font="default" size="100%">Bhatia, Ramya</style></author><author><style face="normal" font="default" size="100%">Cuschieri, Kate</style></author><author><style face="normal" font="default" size="100%">M. Arbyn</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Evaluation of the clinical performance of OncoPredict HPV® SCR assay within the VALGENT‐2 framework</style></title><secondary-title><style face="normal" font="default" size="100%">Journal of Medical Virology</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">cervical cancer</style></keyword><keyword><style  face="normal" font="default" size="100%">HPV genotyping</style></keyword><keyword><style  face="normal" font="default" size="100%">human papillomavirus</style></keyword><keyword><style  face="normal" font="default" size="100%">OncoPredict HPV®</style></keyword><keyword><style  face="normal" font="default" size="100%">test validation.</style></keyword><keyword><style  face="normal" font="default" size="100%">VALGENT</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2023</style></year><pub-dates><date><style  face="normal" font="default" size="100%">Jan-01-2023</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">95</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;Human papillomavirus (HPV) assays used in cervical cancer screening should be clinically validated according to international criteria. OncoPredict HPV® Screening (SCR) is a partial genotyping multiplex real-time PCR assay targeting E6/E7 genes of 13 high-risk (hr) HPVs. OncoPredict HPV® SCR (index assay) identifies HPV-16 and HPV-18 separately, 11 other hrHPV in aggregate and includes quality controls for sample adequacy, DNA extraction efficiency and PCR inhibition. 1300 VALGENT-2 study samples (from women aged 20-60 attending the Scottish cervical cancer screening program) were tested with the index assay and the GP5+/6+ PCR enzyme immunoassay (standard comparator assay). Non-inferior accuracy detecting cervical intraepithelial neoplasia of grade 2 or worse (CIN2+) of the index versus comparator was verified. Intra- and interlaboratory reproducibility of the index was evaluated by overall concordance and Cohen's kappa, using a sub-population (n = 526). Relative sensitivity and specificity for CIN2+ of the index versus comparator were 1.01 (95% confidence interval [CI]: 0.99-1.03) and 1.02 (95% CI: 1.0-1.04), respectively. Noninferiority p values were all ≤0.05, except for CIN3+ in patients ≥30 years. Excellent intra- and interlaboratory reproducibility was shown with concordance &amp;gt;98% and kappas &amp;gt;0.95. OncoPredict HPV® SCR fulfills the three international validation criteria for hrHPV DNA tests in cervical cancer screening.&lt;/p&gt;
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