Abstract:
BACKGROUND:According to international guidelines, HPV DNA tests represent a valid alternative to Pap Test for primary cervical cancer screening, provided that they guarantee balanced clinical sensitivity and specificity for cervical intraepithelial neoplasia grade 2 or more severe lesions. The aim of this study was to assess whether REALQUALITY RQ-HPV Screen, a new assay based on real time PCR that targets the E6-E7 region of 14 high-risk human papillomaviruses, meets the criteria for primary cervical cancer screening. METHODS:As required by guidelines, a non-inferiority test was conducted to compare the clinical performance of the test under evaluation with that of a clinically validated reference test (Hybrid Capture 2, HC2). The reproducibility of the device was assessed as well. The clinical samples used to test the hypothesis of non-inferiority and to asses reproducibility comprised 910 and 536 cervical specimens respectively. All specimens were originating from a population-based screening cohort. RESULTS:The study demonstrates that both the clinical sensitivity and specificity of REALQUALITY RQ-HPV Screen are non-inferior to those of HC2. In addition, an adequate intra- and inter-laboratory reproducibility has been reached by the test. CONCLUSIONS:REALQUALITY RQ-HPV Screen fulfils all the requirements of the international guidelines and can be considered clinically validated for primary cervical cancer screening purposes.
journal_name
Virol Jjournal_title
Virology journalauthors
Iacobellis M,Violante C,Notarachille G,Simone A,Scarfì R,Giuffrè Gdoi
10.1186/s12985-018-0965-zsubject
Has Abstractpub_date
2018-03-20 00:00:00pages
48issue
1issn
1743-422Xpii
10.1186/s12985-018-0965-zjournal_volume
15pub_type
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