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    Background

    SELF-SAMPLING CAN IMPROVE OUTCOMES BY REDUCING BARRIERS TO SCREENING


    Evidence has demonstrated that infections from high-risk strains of HPV can lead to cervical cancer later in life.1,2 In 2016, 1500 new cases of cervical cancer were predicted in Canada, with 400 women expected to die from this disease.3 Early diagnosis and treatment is key in reducing the incidence and prevalence of cervical cancer.4 Widespread cervical cancer screening programs have dramatically reduced cervical cancer incidence rates and deaths. Unfortunately, about 30% of Canadian women are still not receiving regular screening.3,5,6 Low income women, immigrant women, indigenous women and women living in remote communities are less likely to receive screening, putting them at a higher risk of advanced cervical cancer and poor health outcomes.7-9

    Since the late 1990s, sexually transmitted infection (STIs) rates have been steadily increasing in Canada, despite the implementation of widespread and targeted public health programs.1,10 This is of great concern, especially in women, as chlamydia is the most commonly reported bacterial STI in Canada and majority of the cases are asymptomatic. Additionally, there is some evidence that recent changes to cervical screening guidelines may reduce rates of chlamydia screening, especially in younger women at high risk.2 Bacterial STIs, such as chlamydia or gonorrhea, can lead to pelvic inflammatory disease, infertility, or other complications during pregnancy if they’re left untreated.11

    Lower levels of screening have been attributed to a number of barriers, such as lack of knowledge and awareness about STIs, embarrassment and inconvenience, not having a family doctor, and religious, cultural and language barriers.8,9,12-15 Innovative interventions such as self-sampling either at home or in a clinic, have demonstrated improved uptakes rates for testing and screening of HPV and STIs. 10,13,16,17 Women view self-sampling as an acceptable and practical alternative to physician collected samples,15 and studies have shown it to be comparable in sample quality to physician collected samples. 18


    References


    1. Self-collected versus clinician collected samples for sexually transmitted infection testing in women: a review of comparative clinical effectiveness cost-effectiveness, and guidelines [Internet]. Ottawa (ON): CADTH; 2016 Jun 22. (CADTH rapid response reports). Available from: https://www.cadth.ca/sites/default/files/pdf/htis/june-2016/RC0787%20Self%20vs%20Clinician%20Collected%20Samples%20Final.pdf

    2. Ursu A, Sen A, Ruffin M. Impact of cervical cancer screening guidelines on screening for chlamydia. Ann Fam Med [Internet]. 2015 Jul [cited 2017 Jan 11];13(4):361-3. Available from:http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4508178

    3. Canadian cancer statistics. Special topic: HPV-associated cancers [Internet].Statistics Canada; 2016 Oct. Available from:http://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20101/Canadian%20cancer%20statistics/Canadian-Cancer-Statistics-2016-EN.pdf?la=en

    4. Fajardo-Bernal L, Aponte-Gonzalez J, Vigil P, Angel-Müller E, Rincon C, Gaitán HG, et al. Home-based versus clinic-based specimen collection in the management of Chlamydia trachomatis and Neisseria gonorrhoeae infections. Cochrane Database Syst Rev. 2015;9:CD011317.

    5. Canadian Task Force on Preventive Health Care, Dickinson J, Tsakonas E, Conner GS, Lewin G, Shaw E, et al. Recommendations on screening for cervical cancer. CMAJ [Internet]. 2013 Jan 8 ;185(1):35-45. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3537778

    6. Lofters A, Vahabi M. Self-sampling for HPV to enhance uptake of cervical cancer screening: Has the time come in Canada? CMAJ. 2016 Apr 25.

    7. Tota JE, Bentley J, Blake J, Coutl‚e F, Duggan MA, Ferenczy A, et al. Introduction of molecular HPV testing as the primary technology in cervical cancer screening: acting on evidence to change the current paradigm [Internet]. Ottawa: Canadian Cancer Survivor Network; 2015 Dec 9. (Evidence review and report). Available from:http://survivornet.ca/uploads/files/Executive%20Summary%20-%20report%20on%20primary%20HPV%20screening-F2.pdf

    8. New and emerging technologies for self-sampling for cervical cancer screening (HPV) [Internet]. Birmingham (UK): University of Birmingham; 2014 Mar. Available from:http://www.hsric.nihr.ac.uk/topics/new-and-emerging-technologies-for-self-sampling-for-cervical-cancer-screening-hpv-review/

    9. Vahabi M, and Lofters A. Mulism immigrant women’s view on cervical cancer screening and HPV self-sampling in Ontario, Canada. Bmc Public Health. 2016;16:868

    10. Lunny C, Taylor D, Hoang L, Wong T, Gilbert M, Lester R, et al. Self-collected versus clinician-collected sampling for chlamydia and gonorrhea screening: a systemic review and meta-analysis. PLoS One [Internet].2015 ;10(7):e0132776. Available from:http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4500554

    11. Aldeen T, Jacob, J and Powell R. Screening university students for genital chlamydial infection:another lesson to learn. Sexual Health. 2010; 7: 491-494

    12. Sultana F, Mullins R, English DR, Simpson JA, Drennan KT, Heley S, et al. Women's experience with home-based self-sampling for human papillomavirus testing. BMC Cancer [Internet]. 2015 ;15:849. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4634718

    13. Racey CS, Withrow DR, Gesink D. Self-collected HPV testing improves participation in cervical cancer screening: a systematic review and meta-analysis. Can J Public Health. 2013 Mar;104(2):e159-e166.

    14. Szarewski A, Cadman L, Mesher D, Austin J, Ashdown-Barr L, Edwards R, et al. HPV self-sampling as an alternative strategy in non-attenders for cervical screening - a randomised controlled trial. Br J Cancer [Internet]. 2011 Mar 15 ;104(6):915-20. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3065284

    15. Paudyal P, Llewellyn C, Lau J, Mahmud M, Smith H. Obtaining self-samples to diagnose curable sexually transmitted infections: a systematic review of patients' experiences. PLoS One [Internet]. 2015 ;10(4):e0124310. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4409059

    16. Sarai Racey C, Withrow DR, Gesink D. Self-collected HPV testing improves participation in cervical cancer screening: A systematic review and meta-analysis. Can J Public Health [Internet]. 2013 ;104(2):e159-e166. Available from: http://journal.cpha.ca/index.php/cjph/article/viewFile/3776/2765

    17. Verdoodt F, Jentschke M, Hillemanns P, Racey CS, Snijders PJ, Arbyn M. Reaching women who do not participate in the regular cervical cancer screening programme by offering self-sampling kits: a systematic review and meta-analysis of randomised trials. Eur J Cancer. 2015 Nov;51(16):2375-85.

    18. Arbyn M, Verdoodt F, Snijders PJ, Verhoef VM, Suonio E, Dillner L, Minozzi S, Bellisario C, Banzi R, Zhao FH, Hillemanns P, Anttila A. Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol. 2014 Feb;15(2):172-83.

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    Eve Kit Overview

    Using technology to link patients, physicians and lab services together


    Eve Kit was developed to help address the screening gap in Canada by offering an alternative, low-barrier screening method. Eve Kit works in collaboration with licensed physicians and an accredited hospital lab in Toronto. Below is an overview of how the Eve Kit system works.


    Stage 1: Screening Request

    Patient

    • Selects a screening kit
    • Complete risk assessment*
    • Complete informed consent*

    Provider

    • Can review assessments
    • Requisition digitally generated

    Lab

    • Receives digital requisition

    *Orders will not be processed if the patient does not consent or meet requirements

    Stage 2: Sample Collection

    Patient

    • Receives kit and collect samples according to instruction
    • Returns sample to lab by mail in a pre-paid box

    Provider

    • Updated on status

    Lab

    • Receives the sample

    Stage 3: Processing & Results

    Lab

    • Process sample and upload results to portal
    • Informs public health on reportable positives

    Patient

    • Notification of result in portal
    • Informed of result and required counselling if positive
    • Educational materials

    Provider

    • Notification of new result
    • Dashboard in the portal of patient results
    • Positives patients highlighted

    Stage 4: Follow up

    Patient

    • Provider follows up with patient by phone to discuss results

    Provider

    • Provider follows up with patient by phone to discuss results

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    HerSwab Device

    Eve Kit is simple and intuitive for women to use on their own, while collecting high quality samples for molecular diagnostic testing.


    Eve Kit uses the HerSwab™ collection device. The HerSwab™ device was designed specifically with usability, confidence and repeatability in mind. Key design features include an ergonomic handle, colour indicated parts, a familiar aesthetic, and “automatic” collection from close to the cervix.

    HerSwab™ has been tested in over 5000 women, in a number of clinical studies around the world. For highlights, see the Clinical Evidence section.

    HerSwab™ is a class 2 medical device approved by Health Canada, as is Eve Kit (MDL license 94847). Eve Medical is an accredited ISO13485 medical device manufacturer.

    To see the instructions for use included with Eve Kit, click here.


    herswab-device
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    Clinical Evidence

    HerSwab™ has been involved in several clinical studies evaluating effectiveness and acceptability.


    HPV Research


    The recent Cervical And Self-Sample in Screening Study (CASSIS) study, at McGill University, compared the performance of HPV testing using cells collected by three methods: HerSwab™, cobas PCR Female Swab (another self-sampling device), and physician-collected samples in 1,155 women with abnormal Pap test results. Preliminary results, presented at the EUROGIN conference in June 2016, found very good agreement between the HerSwab™ and physician-collected samples: the relative sensitivity for CIN 2 or greater was 0.93; and a Cohen’s kappa of 0.84 to 0.90. There was also very good agreement between HerSwab™ and the cobas PCR Female Swab (Cohen’s kappa: 0.87 to 0.92) for detection of high-risk HPV strains.

    A second study involving the HerSwab™ — a randomized controlled trial of HPV self-sampling for cervical cancer screening — has been conducted in Slovenia. The study compared uptake rates of various self-sampling devices with invitation letters. Data presented in June 2016 at the Eurogin conference found that the overall response was 37.5% in the self-sampling arm (self-sampling or physician visit), compared to 19.9% in the recall letter arm (physician visit only). Of the devices tested, HerSwab™ had a 33.6% response rate compared to 32.4% for the Aprovix Qvintip device and 27.1% for the Delphi Screener.


    Chlamydia and Gonorrhea Research


    A study of 189 patients was conducted with St. Joseph’s Hospital and McMaster University, which compared samples collected with HerSwab™ and physician collected samples, using Chlamydia as an initial validation target. Overall percent agreement between physician-collected and self-collected samples for detection of C. trachomatis was 94.7% (90.2-97.3), 0.64 K (0.47-0.81).


    Acceptability and Preference Data


    Completed surveys from participants in the McMaster study found that 93% of women found the HerSwabTM device very easy or easy to use, 98% found the instructions easy to follow, and 81% of women preferred collecting their own sample compared to the physician.

    In the CASSIS study, 91% of participants reported that HerSwab™ was easy or very easy to use, 73% said HerSwab™ was more comfortable than a pelvic exam, 56% felt that HerSwab™ would collect a better sample than to Roche Swab.
    Another study conducted by the University of Michigan surveyed 202 indigenous women in Santiago Atitlan, Guatemala who used HerSwab™ to test for HPV. 79% of these women found the test comfortable, 91% found the test easy to use, and 100% reported they were willing to perform the test periodically as a screening method.


    Additional Research


    To see additional relevant research related to self-sampling, click here.

    We are always interested in collaborating with researchers on ways to improve screening access. If you are interested in working on a project together, contact us here.



    References


    El-Zein M. Effectiveness of HPV testing [slide deck on the Internet]. Montreal: McGill University; 2016. [cited 2016 Nov 9]. (Presented at HPV Self-Sampling Symposium, Toronto, 2016 Oct 14). Available from: http://equitycancerscreening.ca

    Ivanus U, Primic Zakelj M, Jerman T, Florjancic M, Kuster M, Takac I, et al. HPV self-sampling response rate in randomised study among Slovenian non-responders to the organised cervical cancer screening program [Internet]. Abstract presented at: EUROGIN 2016. 2016 Jun 15-18; Salzburg, Austria. [cited 2016 Nov 9]. Available from: http://eurogin.com/

    Arias M, Jang D, Gilchrist J, Luinstra K, Li J, Smieja M, et al. Ease, Comfort, and Performance of the HerSwab Vaginal Self-Sampling Device for the Detection of Chlamydia trachomatis and Neisseria gonorrhoeae. Sex Transm Dis. 2016 Feb;43(2):125-9.

    Gottschlich A, Rivera-Andrade A, Grajeda E, Alvarez C, Mendoza Montano C, Meza R. Acceptability of Human Papillomavirus Self-Sampling for Cervical Cancer Screening in an Indigenous Community in Guatemala. J Glob Oncol, Published online onascopubs.org on January 18, 2017. Available from: http://ascopubs.org

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    Frequently Asked Questions

    Have a question that isn’t answered below? Comments or feedback? Email us at support@eve-medical.com.



    Eve Kit was developed as an alternative screening method for women (or trans and non-binary individuals) who are unable to access regular screening, or for those who would be more likely to screen at home. It is not intended as a replacement for regular medical care.



    Despite public health programs being in place, the incidence of sexually transmitted infections is rising (PHAC). Around 30% of women are not regularly getting a Pap test, and screening for other STIs is also less than optimal. Self-sampling has been shown to increase screening rates, and to be an acceptable screening method.



    Studies conducted have demonstrated that HerSwab™ (the Eve Kit collection device) is non-inferior to a physician collected sample, and is acceptable to patients. To read more about the research behind Eve Kit, click here.



    Yes, Eve Kit is approved by Health Canada as a Class 2 medical device (MDL license 94847).



    Samples collected are processed at an accredited hospital lab in Toronto on the Roche Cobas 4800 platform.



    Positive results for Chlamydia and Gonorrhea are reported by the lab to public health authorities for surveillance and follow up. Patients must consent to their result potentially being shared with public health prior to ordering a kit.



    Each patient who passes the risk assessment and consent process is assigned to one of Eve Kit’s partner physicians, who assumes the patient’s care. A requisition form for the test is then created digitally and sent to the lab. Interested in working with us? Click here.



    Each patient who passes the risk assessment and consent process is assigned to one of Eve Kit’s partner physicians, who assumes the patient’s care. In the case of positive results, the physician would follow up to provide counselling for the patient. Interested in working with us? Send us an email at support@eve-medical.com



    Eve Kit is only intended for screening in asymptomatic women. Prior to ordering a kit, each user must complete a risk assessment. If a user indicates that they have symptoms, the order will not be completed and a message is displayed encouraging the user to seek immediate care from a physician.



    No, Eve Kit is not recommended for use in pregnant women.



    The Eve Kit portal was developed to meet current standards regarding the security and privacy of personal information. Our system and practices are intended to comply with the Personal Information Protection and Electronic Documents Act (PIPEDA), or with the relevant provincial law regarding Personal Health Information, where applicable. Click here to learn more about our privacy policy.



    Eve Kit is not currently reimbursed. Users paying for Eve Kit choose to do so as anout of pocket, which pays for Eve Kit and the convenience of accessing the associated service at home. Users are notified that they are able to access screening free of charge from their usual healthcare provider. Physicians using the Eve Kit platform are independent contractors compensated for providing uninsured services.



    Eve Medical is a Canadian social enterprise dedicated to improving women’s health. Learn more about us here.

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    Eve Medical

    Our mission is to improve access to screening, in a patient-centred way, on a global scale


    Eve Medical is a Toronto-based social enterprise, dedicated to designing and delivering better healthcare experiences for women. It was founded by Jessica Ching and Evan Moses in 2010 with a simple idea to extend women’s health screening beyond the clinic into the privacy and convenience of women’s homes.

    Motivated by the 500,000 cases of cervical cancer and 23 million cases of infertility that occur worldwide each year, they developed Eve Kit, Canada’s first at-home HPV and STI screening service. Eve Medical is an ISO13485 certified medical device manufacturer and Eve Kit is Health Canada approved.

    To learn more, visit eve-medical.com.

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    Eve Kit

    Our team is all about collaboration. We want to work with healthcare professionals that are interested in providing healthcare in new, innovative ways that can improve patient outcomes. Does that sound like you? support@eve-medical.com

    Research

    We are always interested in working with researchers and healthcare organizations on ways to improve screening access. If you are interested in working on a project together, we would love to hear from you! Get in touch with us at support@eve-medical.com

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