Clinical validation of REALQUALITY RQ-HPV Screen according to the international guidelines for human papillomavirus DNA
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METHODOLOGY
Open Access
Clinical validation of REALQUALITY RQ-HPV Screen according to the international guidelines for human papillomavirus DNA test requirements for cervical screening Michela Iacobellis1, Cecilia Violante1, Gabriella Notarachille1, Angela Simone2, Rosa Scarfì2 and Giuseppe Giuffrè2*
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. Keywords: HPV, DNA testing, Primary cervical cancer screening, International guidelines
Background Cervical cancer screening based on Pap Test represents one of the most successful public health interventions in the last 60 years, having led to the decrease of both cervical cancer incidence and mortality [1]. Recently, randomized control trials, using either of these two high-risk human papillomavirus (hrHPV) DNA testing methods: Hybrid Capture 2 (HC2, QIAGEN, Germany) or GP5+/GP6+ PCR-EIA, have led to recognize them as clinically validated alternatives for use in primary * Correspondence: [email protected] 2 Laboratory of Molecular Biology Applied to Pathologic Anatomy, Department of Human Pathology in Adult and Developmental Age “G. Barresi”, University of Messina, Messina, Italy Full list of author information is available at the end of the article
cervical cancer screening, providing 60–70% greater protection compared with cytology [2, 3]. In general, when used for primary screening, any hrHPV DNA test has to guarantee a balanced clinical sensitivity and specificity in order to allow effective detection of cervical intraepithelial neoplasia grade 2 (CIN2) or more severe lesions (>CIN2) and minimize follow up procedures on HPV test-positive women without clinically meaningfu
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