QUALITY ASSURANCE IN CERVICAL CANCER SCREENING: EVALUATION OF SAMPLE ADEQUACY IN HPV DNA TESTING

QUALITY ASSURANCE IN CERVICAL CANCER SCREENING: EVALUATION OF SAMPLE ADEQUACY IN HPV DNA TESTING | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL Journal of Medical Virology This is a preprint and has not been peer reviewed. Data may be preliminary. 10 January 2025 V1 Latest version Share on QUALITY ASSURANCE IN CERVICAL CANCER SCREENING: EVALUATION OF SAMPLE ADEQUACY IN HPV DNA TESTING Authors : d’Avenia M. 0000-0001-6359-5871 [email protected] , Dell’Anno F. , Marianna Martinelli , Santomauro L. , Ruth C. Njoku , Laila Sara Arroyo Mühr 0000-0003-2498-5206 , Iacobellis M. , and Clementina Cocuzza 0000-0001-6166-1134 Authors Info & Affiliations https://doi.org/10.22541/au.173648222.25258835/v1 440 views 205 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Background: In HPV-primary screening, sample quality significantly influences test accuracy. Unlike cytology-based screening, no consensus guidelines exist for sample quality assessment in HPV testing. This study aims to evaluate the impact of sample cellularity on HPV testing. Methods: A total of 37,592 liquid-based cytology (LBC) samples from women undergoing screening (aged 30-64, mean 47.8±9 years) were analyzed using Cobas®4800 HPV Test (Roche). Sample adequacy was assessed by the assay’s β-globin internal control and by an independent quantitative cellularity assessment (OncoPredict HPV, Hiantis). HPV positivity rates (PR) were stratified according to β-globin Ct values. Results: Overall HPV-PR was 7.7%. PR reached 9.7% in samples with β-globin ≤ 28Ct, decreasing markedly to 1.4% for β-globin > 34 Ct (p < 0.001). Quantitative analysis showed that Cobas®4800 β-globin Ct = 34 corresponds to approximately 1,5x10^3 nucleated cells/rxn. A subset of 195 HPV-negative samples with β-globin Ct ≥34 was evaluated by LBC: 19% had inadequate cellularity according to LBC guidelines, 8% ≥ ASC-US and 73% NILMs, of which 65% showed cellular atrophy. Conclusion: These findings emphasize the importance of assessing cellularity in HPV-screening in order to avoid potentially false-negative results due to inadequate samples. Future research should focus on establishing standardized cellularity thresholds to improve screening accuracy. Supplementary Material File (sample adequacy in ccs_md_fd_cc_mm_sa_to submit 08-01-2025.docx) Download 172.38 KB Information & Authors Information Version history V1 Version 1 10 January 2025 Copyright This work is licensed under a Non Exclusive No Reuse License. Collection Journal of Medical Virology Keywords dna extraction genital tract human papillomavirus oncogenesis pathogenesis research and analysis methods virus classification Authors Affiliations d’Avenia M. 0000-0001-6359-5871 [email protected] ASL Bari View all articles by this author Dell’Anno F. Istituto Zooprofilattico Sperimentale del Piemonte Liguria e Valle d'Aosta - Genova View all articles by this author Marianna Martinelli Universita degli Studi di Milano-Bicocca Dipartimento di Medicina e Chirurgia View all articles by this author Santomauro L. ASL Bari View all articles by this author Ruth C. Njoku Universita degli Studi di Milano-Bicocca Dipartimento di Medicina e Chirurgia View all articles by this author Laila Sara Arroyo Mühr 0000-0003-2498-5206 Karolinska Institutet Institutionen for cell- och molekylaabiologi View all articles by this author Iacobellis M. ASL Bari View all articles by this author Clementina Cocuzza 0000-0001-6166-1134 Universita degli Studi di Milano-Bicocca Dipartimento di Medicina e Chirurgia View all articles by this author Metrics & Citations Metrics Article Usage 440 views 205 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation d’Avenia M., Dell’Anno F., Marianna Martinelli, et al. QUALITY ASSURANCE IN CERVICAL CANCER SCREENING: EVALUATION OF SAMPLE ADEQUACY IN HPV DNA TESTING. Authorea . 10 January 2025. DOI: https://doi.org/10.22541/au.173648222.25258835/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu . 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