Preliminary Results of Feasibility and Acceptability of Self-Collection for Cervical Screening in Italian Women
Background: Given the diagnostic accuracy of HPV-DNA tests in terms of self-collected samples, in order to implement self-sampling in cervical screening programs, the standardization of the pre-analytical phase, including decisions concerning the choice of medium, the volume of elution, and storage...
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MDPI AG
2023-09-01
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| Series: | Pathogens |
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| Online Access: | https://www.mdpi.com/2076-0817/12/9/1169 |
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| author | Illari Sechi Narcisa Muresu Mariangela V. Puci Laura Saderi Arcadia Del Rio Andrea Cossu Maria R. Muroni Santina Castriciano Marianna Martinelli Clementina E. Cocuzza Giovanni Sotgiu Andrea Piana |
| author_facet | Illari Sechi Narcisa Muresu Mariangela V. Puci Laura Saderi Arcadia Del Rio Andrea Cossu Maria R. Muroni Santina Castriciano Marianna Martinelli Clementina E. Cocuzza Giovanni Sotgiu Andrea Piana |
| author_sort | Illari Sechi |
| collection | DOAJ |
| description | Background: Given the diagnostic accuracy of HPV-DNA tests in terms of self-collected samples, in order to implement self-sampling in cervical screening programs, the standardization of the pre-analytical phase, including decisions concerning the choice of medium, the volume of elution, and storage conditions, are necessary, in addition to understanding the potential factors involved in acceptability by women. On this basis, we carried out a cross-sectional study to assess (i) the stability of dry vaginal self-collected samples stored at room temperature for up to 4 weeks after elution in 2 mL of eNat<sup>®</sup> (Copan) medium, and (ii) the acceptability of self-collection in enrolled women. Methods: 185 women were enrolled in the LILT (Italian League Against Tumors) regional project. A self-sampling kit, including a dry FLOQSwab<sup>®</sup> (Copan), instructions for use, and a satisfaction questionnaire, were supplied for each woman and sent by mail to the laboratory. The HPV-DNA test was carried out using the Anyplex™ II HPV HR (Seegene) kit. To evaluate the specimen’s stability, 185 dry vaginal swabs were eluted in eNat<sup>®</sup>, a lyses-based molecular medium and tested for HPV detection at two different time points (<6 days and 1 month after elution). The Cohen’s Kappa coefficients and McNemar test were used to assess the agreement of HPV-DNA at different times. Results: We found high agreement in terms of HPV-DNA results among the samples tested at two different time points (Cohen K = 0.98; <i>p</i> < 0.0001). Moreover, most of the women found it easy to use self-collection devices and the pictorial instructions clear to understand. Approximately half of the enrolled women declared preferring self-sampling to clinician-collected methods. Conclusion: Our results display the high reliability and accuracy of HPV-DNA tests using dry vaginal self-collection FLOQSwabs<sup>®</sup> devices eluted in 2 mL of molecular medium. The analysis of the questionnaire showed a high acceptability of self-collection among women, although a high percentage preferred standard collection devices. Overall, our preliminary results support the adoption of self-collection in screening programs, even though further analyses should be performed to optimize and standardize protocols for HPV tests on self-samples, and educational campaigns are needed to adequately inform and increase responsiveness in a target population. |
| first_indexed | 2024-03-10T22:17:56Z |
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| last_indexed | 2024-03-10T22:17:56Z |
| publishDate | 2023-09-01 |
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| spelling | doaj.art-f190d45f77f24e4a8d11debc2c2569cf2023-11-19T12:23:03ZengMDPI AGPathogens2076-08172023-09-01129116910.3390/pathogens12091169Preliminary Results of Feasibility and Acceptability of Self-Collection for Cervical Screening in Italian WomenIllari Sechi0Narcisa Muresu1Mariangela V. Puci2Laura Saderi3Arcadia Del Rio4Andrea Cossu5Maria R. Muroni6Santina Castriciano7Marianna Martinelli8Clementina E. Cocuzza9Giovanni Sotgiu10Andrea Piana11Department of Medicine, Surgery and Pharmacy, University of Sassari, Padre Manzella 4 Street, 07100 Sassari, ItalyDepartment of Humanities and Social Sciences, University of Sassari, Padre Manzella 4 Street, 07100 Sassari, ItalyClinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Pharmacological Sciences, University of Sassari-Padre Manzella 4 Street, 07100 Sassari, ItalyClinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Pharmacological Sciences, University of Sassari-Padre Manzella 4 Street, 07100 Sassari, ItalyBiomedical Science PhD School, Biomedical Science Department, University of Sassari, Padre Manzella 4 Street, 07100 Sassari, ItalyDepartment of Medicine, Surgery and Pharmacy, University of Sassari, Padre Manzella 4 Street, 07100 Sassari, ItalyDepartment of Medicine, Surgery and Pharmacy, University of Sassari, Padre Manzella 4 Street, 07100 Sassari, ItalyCopan Italia SpA, 25125 Brescia, ItalyDepartment of Medicine and Surgery, University of Milano-Bicocca, Cadore 48 street, 20900 Monza, ItalyDepartment of Medicine and Surgery, University of Milano-Bicocca, Cadore 48 street, 20900 Monza, ItalyClinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Pharmacological Sciences, University of Sassari-Padre Manzella 4 Street, 07100 Sassari, ItalyDepartment of Medicine, Surgery and Pharmacy, University of Sassari, Padre Manzella 4 Street, 07100 Sassari, ItalyBackground: Given the diagnostic accuracy of HPV-DNA tests in terms of self-collected samples, in order to implement self-sampling in cervical screening programs, the standardization of the pre-analytical phase, including decisions concerning the choice of medium, the volume of elution, and storage conditions, are necessary, in addition to understanding the potential factors involved in acceptability by women. On this basis, we carried out a cross-sectional study to assess (i) the stability of dry vaginal self-collected samples stored at room temperature for up to 4 weeks after elution in 2 mL of eNat<sup>®</sup> (Copan) medium, and (ii) the acceptability of self-collection in enrolled women. Methods: 185 women were enrolled in the LILT (Italian League Against Tumors) regional project. A self-sampling kit, including a dry FLOQSwab<sup>®</sup> (Copan), instructions for use, and a satisfaction questionnaire, were supplied for each woman and sent by mail to the laboratory. The HPV-DNA test was carried out using the Anyplex™ II HPV HR (Seegene) kit. To evaluate the specimen’s stability, 185 dry vaginal swabs were eluted in eNat<sup>®</sup>, a lyses-based molecular medium and tested for HPV detection at two different time points (<6 days and 1 month after elution). The Cohen’s Kappa coefficients and McNemar test were used to assess the agreement of HPV-DNA at different times. Results: We found high agreement in terms of HPV-DNA results among the samples tested at two different time points (Cohen K = 0.98; <i>p</i> < 0.0001). Moreover, most of the women found it easy to use self-collection devices and the pictorial instructions clear to understand. Approximately half of the enrolled women declared preferring self-sampling to clinician-collected methods. Conclusion: Our results display the high reliability and accuracy of HPV-DNA tests using dry vaginal self-collection FLOQSwabs<sup>®</sup> devices eluted in 2 mL of molecular medium. The analysis of the questionnaire showed a high acceptability of self-collection among women, although a high percentage preferred standard collection devices. Overall, our preliminary results support the adoption of self-collection in screening programs, even though further analyses should be performed to optimize and standardize protocols for HPV tests on self-samples, and educational campaigns are needed to adequately inform and increase responsiveness in a target population.https://www.mdpi.com/2076-0817/12/9/1169cervical screeningvaginal self-collectionhuman papillomavirusacceptability self-collectionHPV-DNA testelution medium |
| spellingShingle | Illari Sechi Narcisa Muresu Mariangela V. Puci Laura Saderi Arcadia Del Rio Andrea Cossu Maria R. Muroni Santina Castriciano Marianna Martinelli Clementina E. Cocuzza Giovanni Sotgiu Andrea Piana Preliminary Results of Feasibility and Acceptability of Self-Collection for Cervical Screening in Italian Women Pathogens cervical screening vaginal self-collection human papillomavirus acceptability self-collection HPV-DNA test elution medium |
| title | Preliminary Results of Feasibility and Acceptability of Self-Collection for Cervical Screening in Italian Women |
| title_full | Preliminary Results of Feasibility and Acceptability of Self-Collection for Cervical Screening in Italian Women |
| title_fullStr | Preliminary Results of Feasibility and Acceptability of Self-Collection for Cervical Screening in Italian Women |
| title_full_unstemmed | Preliminary Results of Feasibility and Acceptability of Self-Collection for Cervical Screening in Italian Women |
| title_short | Preliminary Results of Feasibility and Acceptability of Self-Collection for Cervical Screening in Italian Women |
| title_sort | preliminary results of feasibility and acceptability of self collection for cervical screening in italian women |
| topic | cervical screening vaginal self-collection human papillomavirus acceptability self-collection HPV-DNA test elution medium |
| url | https://www.mdpi.com/2076-0817/12/9/1169 |
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