CC BY 4.0 · Rev Bras Ginecol Obstet 2023; 45(05): 235-241
DOI: 10.1055/s-0043-1770134
Original Article
Oncology

A New Brazilian Device for Cervical Cancer Screening: Acceptability and Accuracy of Self-sampling

Um Novo Dispositivo Brasileiro para Diagnóstico de Câncer Cervical: Aceitabilidade e Precisão da Autoamostragem
1   Ziel Biosciences, Porto Alegre, RS, Brazil
,
2   Department of Gynecology, Instituto do Câncer do Estado de São Paulo, São Paulo, SP, Brazil
,
3   Department of Gynecology, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil
,
2   Department of Gynecology, Instituto do Câncer do Estado de São Paulo, São Paulo, SP, Brazil
,
Flávia Frustockl
4   Citoclin Laboratory, Porto Alegre, RS, Brazil
,
1   Ziel Biosciences, Porto Alegre, RS, Brazil
,
5   Santa Casa de Misericórdia de Porto Alegre, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brazil
,
6   Centro de Investigação Translacional em Oncologia, Instituto do Câncer do Estado de São Paulo, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo, São Paulo, São Paulo, Brazil
,
1   Ziel Biosciences, Porto Alegre, RS, Brazil
› Author Affiliations

Abstract

Objective To evaluate the accuracy and patient acceptability toward self-sampling using a new device - SelfCervix® - for detecting HPV-DNA.

Methods A total of 73 women aged 25–65 who underwent regular cervical cancer screening from March to October 2016 were included. Women performed self-sampling followed by a physician-sampling, and the samples were analyzed for HPV-DNA. After that, patients were surveyed about their acceptability of self-sampling.

Results HPV-DNA detection rate of self-sampling presented high accuracy and was similar to physician-collection. Sixty-four (87.7%) patients answered the acceptability survey. Most patients (89%) considered the self-sampling comfortable, and 82.5% preferred self-sampling to physician-sampling. The reasons cited were time-saving and convenience. Fifty-one (79.7%) reported that they would recommend self-sampling.

Conclusion Self-sampling using the new Brazilian device SelfCervix® is not inferior in HPV-DNA detection rate compared with physician-collection, and patients are supportive of the method. Therefore, it might be an option to reach under-screened populations in Brazil.

Resumo

Objetivo Avaliar a acurácia e aceitabilidade da auto-coleta utilizando um novo coletor - SelfCervix® - para a detecção de DNA de HPV.

Métodos Foram incluídas no estudo 73 mulheres com idade entre 25–65 anos que realizaram seu rastreamento regular do câncer de colo do útero entre Março e Outubro de 2016. Estas mulheres realizaram a auto-coleta, seguida de coleta profissional e as amostras foram analisadas para a presença de DNA de HPV. Após, elas responderam um questionário sobre a experiência da auto-coleta.

Resultados As taxas de detecção de DNA de HPV por auto-coleta foram altas e similares as da coleta profissional. Sessenta e quatro (87,7%) pacientes responderam o questionário de experiência. A maioria (89%) considerou a auto-coleta confortável, e 82,5% preferiram o método comparado a coleta profissional. As razões citadas foram economia de tempo e conveniência. Cinquenta e uma (79,7%) mulheres confirmaram que recomendariam a auto-coleta.

Conclusão Auto-coleta utilizando o novo coletor desenvolvido no Brasil não é inferior na detecção de DNA de HPV quando comparada a coleta profissional, e apresenta uma boa aceitabilidade pelas mulheres. Desta maneira, pode ser uma opção para alcançar populações que não realizam o rastreamento padrão.

Contributions

All authors participated in the concept and design of the present study; analysis and interpretation of data; draft or revision of the manuscript, and they have approved the manuscript as submitted. All authors are responsible for the reported research.




Publication History

Received: 26 January 2023

Accepted: 20 March 2023

Article published online:
20 June 2023

© 2023. Federação Brasileira de Ginecologia e Obstetrícia. This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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  • References

  • 1 Arbyn M, Weiderpass E, Bruni L. et al. Estimates of incidence and mortality of cervical cancer in 2018: a worldwide analysis. Lancet Glob Health 2020; 8 (02) e191-e203
  • 2 Spence AR, Goggin P, Franco EL. Process of care failures in invasive cervical cancer: systematic review and meta-analysis. Prev Med 2007; 45 (2-3): 93-106
  • 3 Jackson R, Wang L, Jembere N, Murphy J, Kupets R. Why do women get cervical cancer in an organized screening program in Canada?. J Low Genit Tract Dis 2019; 23 (01) 1-6
  • 4 Vaccarella S, Lortet-Tieulent J, Plummer M, Franceschi S, Bray F. Worldwide trends in cervical cancer incidence: impact of screening against changes in disease risk factors. Eur J Cancer 2013; 49 (15) 3262-3273
  • 5 Augusto EF, Rosa MLG, Cavalcanti SMB, Oliveira LHS. Barriers to cervical cancer screening in women attending the Family Medical Program in Niterói, Rio de Janeiro. Arch Gynecol Obstet 2013; 287 (01) 53-58
  • 6 Schiffman M, Doorbar J, Wentzensen N. et al. Carcinogenic human papillomavirus infection. Nat Rev Dis Primers 2016; 2: 16086
  • 7 Lenhoff A. Five FDA-approved HPV assays. MLO Med Lab Obs 2012; 44 (07) 14 , 16, 18
  • 8 Fontham ETH, Wolf AMD, Church TR. et al. Cervical cancer screening for individuals at average risk: 2020 guideline update from the American Cancer Society. CA Cancer J Clin 2020; 70 (05) 321-346
  • 9 Castle PE, Silva VRS, Consolaro MEL. et al. Participation in cervical screening by self-collection, Pap, or a choice of either in Brazil. Cancer Prev Res (Phila) 2019; 12 (03) 159-170
  • 10 Demarco M, Hyun N, Carter-Pokras O. et al. A study of type-specific HPV natural history and implications for contemporary cervical cancer screening programs. EClinicalMedicine 2020; 22: 100293
  • 11 Arbyn M, Smith SB, Temin S, Sultana F, Castle P. Collaboration on self-sampling and hpv testing. Detecting cervical precancer and reaching underscreened women by using HPV testing on self-samples: updated meta-analyses. BMJ 2018; 5: 363
  • 12 El-Zein M, Bouten S, Louvanto K. et al; CASSIS Study Group*. Predictive value of HPV testing in self-colleted and clinician-collected samples compared with cytology in detecting high-grade cervical lesions. Cancer Epidemiol Biomarkers Prev 2019; 28 (07) 1134-1140
  • 13 Arrossi S, Thouyaret L, Herrero R. et al; EMA Study team. Effect of self-collection of HPV DNA offered by community health workers at home visits on uptake of screening for cervical cancer (the EMA study): a population-based cluster-randomised trial. Lancet Glob Health 2015; 3 (02) e85-e94
  • 14 Torres KL, Mariño JM, Pires Rocha DA. et al. Self-sampling coupled to the detection of HPV 16 and 18 E6 protein: A promising option for detection of cervical malignancies in remote areas. PLoS One 2018; 13 (07) e0201262
  • 15 Bornstein J, Bentley J, Bösze P. et al. 2011 colposcopic terminology of the International Federation for Cervical Pathology and Colposcopy. Obstet Gynecol 2012; 120 (01) 166-172
  • 16 Ronco G, Dillner J, Elfström KM. et al; International HPV screening working group. Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials. Lancet 2014; 383 (9916): 524-532
  • 17 Aitken CA, van Agt HME, Siebers AG. et al. Introduction of primary screening using high-risk HPV DNA detection in the Dutch cervical cancer screening programme: a population-based cohort study. BMC Med 2019; 17 (01) 228-231
  • 18 Rebolj M, Rimmer J, Denton K. et al. Primary cervical screening with high risk human papillomavirus testing: observational study. BMJ 2019; 364: l240
  • 19 Koliopoulos G, Nyaga VN, Santesso N. et al. Cytology versus HPV testing for cervical cancer screening in the general population. Cochrane Database Syst Rev 2017; 8 (08) CD008587
  • 20 Thomsen LT, Kjaer SK, Munk C, Ørnskov D, Waldstrøm M. Benefits and potential harms of human papillomavirus (HPV)-based cervical cancer screening: A real-world comparison of HPV testing versus cytology. Acta Obstet Gynecol Scand 2021; 100 (03) 394-402
  • 21 Zhao Y, Bao H, Ma L. et al. Real-world effectiveness of primary screening with high-risk human papillomavirus testing in the cervical cancer screening programme in China: a nationwide, population-based study. BMC Med 2021; 19 (01) 164
  • 22 Smith MA, Canfell K. Projected impact of HPV vaccination and primary HPV screening on cervical adenocarcinoma: Example from Australia. Papillomavirus Res 2017; 3: 134-141
  • 23 Katki HA, Kinney WK, Fetterman B. et al. Cervical cancer risk for women undergoing concurrent testing for human papillomavirus and cervical cytology: a population-based study in routine clinical practice. Lancet Oncol 2011; 12 (07) 663-672 . Doi: 10/1016/S1470–2045(11)70145–0
  • 24 Loopik DL, Koenjer LM, Siebers AG, Melchers WJG, Bekkers RLM. Benefit and burden in the Dutch cytology-based vs high-risk human papillomavirus-based cervical cancer screening program. Am J Obstet Gynecol 2021; 224 (02) 200.e1-200.e9
  • 25 Teixeira JC, Vale DB, Bragança JF, Campos CS, Discacciati MG, Zeferino LC. Cervical cancer screening program based on primary DNA-HPV testing in a Brazilian city: a cost-effectiveness study protocol. BMC Public Health 2020; 20 (01) 576
  • 26 Vale DB, Teixeira JC, Bragança JF, Derchain S, Sarian LO, Zeferino LC. Elimination of cervical cancer in low- and middle-income countries: Inequality of access and fragile healthcare systems. Int J Gynaecol Obstet 2021; 152 (01) 7-11
  • 27 Vale DB, Silva MT, Discacciati MG, Polegatto I, Teixeira JC, Zeferino LC. Is the HPV-test more cost-effective than cytology in cervical cancer screening? An economic analysis from a middle-income country. PLoS One 2021; 16 (05) e0251688
  • 28 Cromwell I, Smith LW, van der Hoek K. et al. Cost-effectiveness analysis of primary human papillomavirus testing in cervical cancer screening: Results from the HPV FOCAL Trial. Cancer Med 2021; 10 (09) 2996-3003
  • 29 Gottschlich A, van Niekerk D, Smith LW. et al. Assessing 10-year safety of a single negative HPV test for cervical cancer screening: Evidence from FOCAL-DECADE cohort. Cancer Epidemiol Biomarkers Prev 2021; 30 (01) 22-29
  • 30 Polman NJ, de Haan Y, Veldhuijzen NJ. et al. Experience with HPV self-sampling and clinician-based sampling in women attending routine cervical screening in the Netherlands. Prev Med 2019; 125: 5-11
  • 31 Polman NJ, Ebisch RMF, Heideman DAM. et al. Performance of human papillomavirus testing on self-collected versus clinician-collected samples for the detection of cervical intraepithelial neoplasia of grade 2 or worse: a randomised, paired screen-positive, non-inferiority trial. Lancet Oncol 2019; 20 (02) 229-238
  • 32 Bertucci M, Bonnet E, Satger L. et al. Acceptability of vaginal self-sampling with high-risk human papillomavirus testing for cervical cancer screening: a French questionnaire-based study. Women Health 2021; 61 (01) 83-94
  • 33 Andersson S, Belkić K, Mints M, Östensson E. Acceptance of self-sampling among long-term cervical screening non-attenders with HPV-positive results: promising opportunity for specific cancer education. J Cancer Educ 2021; 36 (01) 126-133
  • 34 Lorenzi NPC, Termini L, Longatto Filho A. et al. Age-related acceptability of vaginal self-sampling in cervical cancer screening at two university hospitals: a pilot cross-sectional study. BMC Public Health 2019; 19 (01) 963
  • 35 Mezei AK, Armstrong HL, Pedersen HN. et al. Cost-effectiveness of cervical cancer screening methods in low- and middle-income countries: A systematic review. Int J Cancer 2017; 141 (03) 437-446
  • 36 Bhatla N, Dar L, Patro AR. et al. Can human papillomavirus DNA testing of self-collected vaginal samples compare with physician-collected cervical samples and cytology for cervical cancer screening in developing countries?. Cancer Epidemiol 2009; 33 (06) 446-450
  • 37 Chen C, Yang Z, Li Z, Li L. Accuracy of several cervical screening strategies for early detection of cervical cancer: a meta-analysis. Int J Gynecol Cancer 2012; 22 (06) 908-921
  • 38 Kamath Mulki A, Withers M. Human Papilloma Virus self-sampling performance in low- and middle-income countries. BMC Womens Health 2021; 21 (01) 12
  • 39 Nishimura H, Yeh PT, Oguntade H, Kennedy CE, Narasimhan M. HPV self-sampling for cervical cancer screening: a systematic review of values and preferences. BMJ Glob Health 2021; 6 (05) e003743