An evaluation of solid versus liquid transport media for high-risk HPV detection and cervical cancer screening on self-c
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RESEARCH ARTICLE
Open Access
An evaluation of solid versus liquid transport media for high-risk HPV detection and cervical cancer screening on selfcollected specimens Hui Du1†, Xianzhi Duan2†, Yan Liu3†, Bin Shi4†, Wei Zhang5†, Chun Wang1, Xinfen Qu1, Juncui Bao1, Jingran Li6, Chao Zhao6, Jing Jiang4, Juan Liu3, Kejia Wu5, Aimin Xiao1, Lvfang Duan1, Xia Huang1, Shuhuang Bian1, Lijie Zhang1, Hongxue Luo1, Lihui Wei6*, Jerome L. Belinson7*, Ruifang Wu1* and CHIMUST group
Abstract Background: The solid transport media is a small size card that allows fast, easy DNA extraction from a variety of biological samples. In 2016 we developed a solid media transport card; for that pilot study to control the selfcollection we used a pseudo-self-collection technique. The current study expands this prior work using true selfcollections and only the POI card, and aims to evaluate the solid media transport card to detect HR-HPV in selfsamples compared to liquid transport media. Methods: Ten thousand eight hundred eighty-five women between the ages of 30–59 with no screening for 3 years were enrolled. The self-collected sample was first applied to a new solid media transport card (Labeled as SC) then the brush placed in 6 ml ThinPrep liquid (Labeled as SL). Then a physician collected a direct endocervical specimen into ThinPrep liquid (Labeled as DL). Samples were tested with Cobas 4800 and the SeqHPV NGS assay for HR-HPV. Patients positive on any test were recalled for colposcopy and biopsy. Results: Ten thousand three hundred thirty-nine participants had complete data. The mean age was 43.9 years. CIN 2+ rates were 1.4% (142/10339). The agreement in HPV detection between the two different self-sample collection media was also good (Cobas HPV kappa = 0.86; SeqHPV kappa = 0.98). Tested with Cobas, the sensitivity of Cobas-SL and Cobas-SC for CIN 2+ was95.07 and 94.37%; and for CIN3+ was 96.30, 96.30% respectively. The specificity of Cobas-SC, and Cobas-SL for CIN2+ was 88.74 and 87.35%; for CIN3 was 88.04and 86.65% respectively. Tested with SeqHPV, the sensitivity for CIN2+ of Seq-SC and Seq-SL was 95.77 and 96.48%; for CIN3+, both the SC and SL specimens had a sensitivity of 100%. The specificity for CIN2+ of Seq-SC and Seq-SL was 89.54 and 89.53%; for CIN3+ was 88.84,88.82% respectively. For both HR-HPV assays, the sensitivities were similar for the two self-sample media (SC vs SL, p = 1.00). (Continued on next page)
* Correspondence: [email protected]; [email protected]; [email protected] † Hui Du, Xianzhi Duan, Yan Liu, Bin Shi and Wei Zhang contributed equally to this work. 6 Peking University People’s Hospital, Beijing, PR China 7 Preventive Oncology International Inc, and the Cleveland Clinic, Cleveland, OH, USA 1 Peking University Shenzhen Hospital, Shenzhen, PR China Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproductio
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