Human papillomavirus (HPV) detection in vaginal self-samples: evaluation of eNat® as an alternative suspension medium to ThinPrep®PreservCyt® for vaginal swabs [version 2; peer review: 2 approved]
Human Papillomavirus (HPV) testing on self-collected samples allows for improved coverage rates of cervical cancer (CC) screening programs. ThinPrep®PreservCyt® (HOLOGIC®, USA) medium is widely used for the suspension of cervical and vaginal self-samples. However, this medium is costly, toxic, and f...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
F1000 Research Ltd
2022-07-01
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| Series: | Open Research Europe |
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| Online Access: | https://open-research-europe.ec.europa.eu/articles/2-35/v2 |
| _version_ | 1798040531709722624 |
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| author | Chiara Giubbi Ivan Vallini Marianna Martinelli Tarig Dafa'alla Silvia Paganoni Rosario Musumeci Federica Perdoni Santina Castriciano Winnie Wu Clementina E. Cocuzza Paolo Romano |
| author_facet | Chiara Giubbi Ivan Vallini Marianna Martinelli Tarig Dafa'alla Silvia Paganoni Rosario Musumeci Federica Perdoni Santina Castriciano Winnie Wu Clementina E. Cocuzza Paolo Romano |
| author_sort | Chiara Giubbi |
| collection | DOAJ |
| description | Human Papillomavirus (HPV) testing on self-collected samples allows for improved coverage rates of cervical cancer (CC) screening programs. ThinPrep®PreservCyt® (HOLOGIC®, USA) medium is widely used for the suspension of cervical and vaginal self-samples. However, this medium is costly, toxic, and flammable, involving special handling procedures which make its use difficult in screening programs, particularly in low- and middle-income countries. This pilot study aimed to evaluate the analytical performance of eNat® (Copan SpA), an alternative non-alcohol-based suspension medium, compared to ThinPrep®PreservCyt® (HOLOGIC®) for high-risk HPV (hrHPV) detection in vaginal self-collected swabs using three different real-time polymerase chain reaction (RT-PCR) HPV assays: Anyplex™II HPV28 (Seegene, Korea), Papilloplex® High Risk HPV (GeneFirst, UK), and HPV OncoPredict (Hiantis, Italy). 30 women, referred to colposcopy, were enrolled in this observational, prospective pilot study and asked to collect two vaginal self-taken samples, which were suspended in 5 mL of ThinPrep®PreservCyt® or eNat®. Nucleic acids were extracted from 200 μL using Microlab Nimbus platform (Seegene, Korea) and tested with the three different RT-PCR full-genotyping high-risk HPV assays. The HPV results of vaginal samples resuspended in the two different media were compared to those obtained from the reference clinician-collected cervical sample from the same woman. hrHPV detection in vaginal self-samples suspended in both media demonstrated a substantial agreement with cervical samples with the three assays under-investigation (0.667<k<0.796). Moreover, the discordances between vaginal self-samples collected from the same woman were found only in cases of normal cytology or low-grade cytological lesions and were generally related to low hrHPV viral loads as indicated by the quantitative HPV OncoPredict assay (6.24E+02 copies/10,000 cells). The study's preliminary findings demonstrated a very good agreement between cervical and vaginal self-collected samples suspended in ThinPrep®PreservCyt® and eNat®, suggesting that the latter could represent a good alternative medium in HPV screening programs based on self-collection. |
| first_indexed | 2024-04-11T22:08:55Z |
| format | Article |
| id | doaj.art-8e8e4b06855e445ca086b48da460411b |
| institution | Directory Open Access Journal |
| issn | 2732-5121 |
| language | English |
| last_indexed | 2024-04-11T22:08:55Z |
| publishDate | 2022-07-01 |
| publisher | F1000 Research Ltd |
| record_format | Article |
| series | Open Research Europe |
| spelling | doaj.art-8e8e4b06855e445ca086b48da460411b2022-12-22T04:00:36ZengF1000 Research LtdOpen Research Europe2732-51212022-07-01216153Human papillomavirus (HPV) detection in vaginal self-samples: evaluation of eNat® as an alternative suspension medium to ThinPrep®PreservCyt® for vaginal swabs [version 2; peer review: 2 approved]Chiara Giubbi0https://orcid.org/0000-0001-6112-7572Ivan Vallini1Marianna Martinelli2https://orcid.org/0000-0003-2273-6986Tarig Dafa'alla3Silvia Paganoni4Rosario Musumeci5https://orcid.org/0000-0003-0143-3601Federica Perdoni6Santina Castriciano7Winnie Wu8Clementina E. Cocuzza9https://orcid.org/0000-0001-6166-1134Paolo Romano10Department of Medicine and Surgery, University of Milano-Bicocca, Monza, ItalyHiantis S.r.l., Milano, ItalyDepartment of Medicine and Surgery, University of Milano-Bicocca, Monza, ItalyGeneFirst Ltd., Abingdon, OX14 3DB, UKHiantis S.r.l., Milano, ItalyDepartment of Medicine and Surgery, University of Milano-Bicocca, Monza, ItalyDepartment of Medicine and Surgery, University of Milano-Bicocca, Monza, ItalyCopan Italia SpA, Brescia, ItalyGeneFirst Ltd., Abingdon, OX14 3DB, UKDepartment of Medicine and Surgery, University of Milano-Bicocca, Monza, ItalyHiantis S.r.l., Milano, ItalyHuman Papillomavirus (HPV) testing on self-collected samples allows for improved coverage rates of cervical cancer (CC) screening programs. ThinPrep®PreservCyt® (HOLOGIC®, USA) medium is widely used for the suspension of cervical and vaginal self-samples. However, this medium is costly, toxic, and flammable, involving special handling procedures which make its use difficult in screening programs, particularly in low- and middle-income countries. This pilot study aimed to evaluate the analytical performance of eNat® (Copan SpA), an alternative non-alcohol-based suspension medium, compared to ThinPrep®PreservCyt® (HOLOGIC®) for high-risk HPV (hrHPV) detection in vaginal self-collected swabs using three different real-time polymerase chain reaction (RT-PCR) HPV assays: Anyplex™II HPV28 (Seegene, Korea), Papilloplex® High Risk HPV (GeneFirst, UK), and HPV OncoPredict (Hiantis, Italy). 30 women, referred to colposcopy, were enrolled in this observational, prospective pilot study and asked to collect two vaginal self-taken samples, which were suspended in 5 mL of ThinPrep®PreservCyt® or eNat®. Nucleic acids were extracted from 200 μL using Microlab Nimbus platform (Seegene, Korea) and tested with the three different RT-PCR full-genotyping high-risk HPV assays. The HPV results of vaginal samples resuspended in the two different media were compared to those obtained from the reference clinician-collected cervical sample from the same woman. hrHPV detection in vaginal self-samples suspended in both media demonstrated a substantial agreement with cervical samples with the three assays under-investigation (0.667<k<0.796). Moreover, the discordances between vaginal self-samples collected from the same woman were found only in cases of normal cytology or low-grade cytological lesions and were generally related to low hrHPV viral loads as indicated by the quantitative HPV OncoPredict assay (6.24E+02 copies/10,000 cells). The study's preliminary findings demonstrated a very good agreement between cervical and vaginal self-collected samples suspended in ThinPrep®PreservCyt® and eNat®, suggesting that the latter could represent a good alternative medium in HPV screening programs based on self-collection.https://open-research-europe.ec.europa.eu/articles/2-35/v2Human Papillomavirus (HPV) HPV-testing vaginal self-collection ThinPrep®PreservCyt eNat®eng |
| spellingShingle | Chiara Giubbi Ivan Vallini Marianna Martinelli Tarig Dafa'alla Silvia Paganoni Rosario Musumeci Federica Perdoni Santina Castriciano Winnie Wu Clementina E. Cocuzza Paolo Romano Human papillomavirus (HPV) detection in vaginal self-samples: evaluation of eNat® as an alternative suspension medium to ThinPrep®PreservCyt® for vaginal swabs [version 2; peer review: 2 approved] Open Research Europe Human Papillomavirus (HPV) HPV-testing vaginal self-collection ThinPrep®PreservCyt eNat® eng |
| title | Human papillomavirus (HPV) detection in vaginal self-samples: evaluation of eNat® as an alternative suspension medium to ThinPrep®PreservCyt® for vaginal swabs [version 2; peer review: 2 approved] |
| title_full | Human papillomavirus (HPV) detection in vaginal self-samples: evaluation of eNat® as an alternative suspension medium to ThinPrep®PreservCyt® for vaginal swabs [version 2; peer review: 2 approved] |
| title_fullStr | Human papillomavirus (HPV) detection in vaginal self-samples: evaluation of eNat® as an alternative suspension medium to ThinPrep®PreservCyt® for vaginal swabs [version 2; peer review: 2 approved] |
| title_full_unstemmed | Human papillomavirus (HPV) detection in vaginal self-samples: evaluation of eNat® as an alternative suspension medium to ThinPrep®PreservCyt® for vaginal swabs [version 2; peer review: 2 approved] |
| title_short | Human papillomavirus (HPV) detection in vaginal self-samples: evaluation of eNat® as an alternative suspension medium to ThinPrep®PreservCyt® for vaginal swabs [version 2; peer review: 2 approved] |
| title_sort | human papillomavirus hpv detection in vaginal self samples evaluation of enat r as an alternative suspension medium to thinprep r preservcyt r for vaginal swabs version 2 peer review 2 approved |
| topic | Human Papillomavirus (HPV) HPV-testing vaginal self-collection ThinPrep®PreservCyt eNat® eng |
| url | https://open-research-europe.ec.europa.eu/articles/2-35/v2 |
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