<?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%">Bhatia, Ramya</style></author><author><style face="normal" font="default" size="100%">Elia Alcaniz Boada</style></author><author><style face="normal" font="default" size="100%">Bonde, Jesper Hansen</style></author><author><style face="normal" font="default" size="100%">Wim G V Quint</style></author><author><style face="normal" font="default" size="100%">Xu, Lan</style></author><author><style face="normal" font="default" size="100%">Ejegod, Ditte Moller</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%">Papilloplex HR-HPV test has non-inferior clinical performance for detection of human papillomavirus infection: assessment using the VALGENT framework.</style></title><secondary-title><style face="normal" font="default" size="100%">J Clin Pathol</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">Early Detection of Cancer</style></keyword><keyword><style  face="normal" font="default" size="100%">Female</style></keyword><keyword><style  face="normal" font="default" size="100%">Human Papillomavirus Viruses</style></keyword><keyword><style  face="normal" font="default" size="100%">Humans</style></keyword><keyword><style  face="normal" font="default" size="100%">Papillomaviridae</style></keyword><keyword><style  face="normal" font="default" size="100%">Papillomavirus Infections</style></keyword><keyword><style  face="normal" font="default" size="100%">Sensitivity and Specificity</style></keyword><keyword><style  face="normal" font="default" size="100%">Uterine Cervical Dysplasia</style></keyword><keyword><style  face="normal" font="default" size="100%">Uterine Cervical Neoplasms</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%">March 2023 </style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">76</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;&lt;b&gt;&lt;strong style=&quot;color:#69aa41;&quot;&gt;AIM:&lt;/strong&gt; &lt;/b&gt;&lt;br&gt;
The Papilloplex high-risk human papillomavirus (hrHPV) test (Genefirst, Oxford, UK) is a single tube real-time HPV test which provides multiplex detection and separate identification of 14 hrHPV types. Here, we present the clinical validation of the test in SurePath samples in comparison to a clinically validated reference test, the GP5+/6+Enzyme ImmunoAssay (GP5+/6+EIA) using the VALGENT (VALidation of HPV GENotyping Tests) framework.&lt;/p&gt;

&lt;p&gt;&lt;strong style=&quot;color:#69aa41;&quot;&gt;&lt;b&gt;METHODS: &lt;/b&gt;&lt;/strong&gt;&lt;br&gt;
Clinical performance was assessed using 998 unselected, cervical screening samples enriched with 297 cytologically abnormal specimens (100 atypical squamous cells of unspecified significance, 100 low-grade squamous intraepithelial lesions, 97 high-grade squamous intraepithelial lesions). Cases were defined as women diagnosed with histologically confirmed cervical intraepithelial neoplasia two or more (≥CIN2, N=119) and controls defined as women with two subsequent negative cytology results (N=834).&lt;/p&gt;

&lt;p&gt;&lt;b&gt;&lt;strong style=&quot;color:#69aa41;&quot;&gt;RESULTS:&lt;/strong&gt; &lt;/b&gt;&lt;br&gt;
The Papilloplex HR-HPV test has non-inferior sensitivity for detection of cervical precancer (p=0.0001 for ≥CIN2 and p=0.0005 for ≥CIN3) and non-inferior specificity, compared with GP5+/6+EIA (pni=0.0167)). The assay also showed excellent or good agreement for overall hrHPV and nearly all individual HPV types as compared with GP5+/6+EIA/Luminex.&lt;/p&gt;

&lt;p&gt;&lt;b&gt;&lt;strong style=&quot;color:#69aa41;&quot;&gt;CONCLUSION:&lt;/strong&gt; &lt;/b&gt;&lt;br&gt;
The Papilloplex HR-HPV applied on cervical specimens stored in SurePath medium fulfils the international clinical accuracy criteria for use in cervical cancer screening.&lt;/p&gt;
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