Healthcare Providers

For Healthcare Providers

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.7,8,9 

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.8,9,12,13,14,15 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

Service Overview

Using Technology to link patients, physicians and lab services

The Eve Kit Service was developed to help address the screening gap in Canada by offering an alternative, low-barrier screening method. The Eve Kit Service works in collaboration with licensed physicians and an accredited labs. Here's how the Eve Kit Service works:

Stage 1: Screening Request

Patient

• Purchases and registers kit online
• Completes risk assessment*
• Completes 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

• If ordered online, receives kit
• Collects 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

COLLECTION DEVICE

EVE KIT IS SIMPLE AND INTUITIVE FOR WOMEN TO USE ON THEIR OWN, WHILE COLLECTING HIGH QUALITY SAMPLES FOR MOLECULAR DIAGNOSTIC TESTING

The Eve Kit collection device is also marketed as 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 used by over 6000 patients, in a number of clinical studies around the world. For highlights, see the Clinical Evidence section.

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

>>> Learn more about HerSwab™'s features

Clinical Evidence

HerSwab™ HAS BEEN INVOLVED IN SEVERAL CLINICAL STUDIES EVALUATING EFFECTIVENESS AND ACCEPTABILITY

GOOD AGREEMENT WITH PHYSICIAN SAMPLING FOR DETECTING HPV


The CASSIS (Cervical and Self-Sample in Screening) study conducted by McGill University aimed to evaluate the diagnostic performance of HPV testing (Cobas 4800) with the HerSwab™ self-sampling device compared with standard physician-collected samples for the detection of cervical intraepithelial neoplasia grade 1 or worse (CIN1+) and cervical cancer among women referred for colposcopy. The performance of HerSwab™ was also compared with a second self-sample via a cobas® PCR Female swab. The results of the study (n=1217) demonstrated that HerSwab™ is non-inferior to physician collected samples for HPV testing and the two sample types were deemed to have very good agreement for HPV detection with a Cohen’s kappa of 0.84. Compared to the physician-collected sample, HerSwab had relative sensitivity of 0.93 for CIN2+ and 0.96 for CIN3+. The CASSIS study also demonstrated that HerSwab™ has higher specificity for CIN2+ compared to a standard self-collected swab at 87.6% (95% CI: 79.8-93.2).

Another comparison study conducted with 48 participants in Colombia found a kappa coefficient of 0.84 (95% CI: 0.71-0.96) for concordance in high-risk HPV detection.  


GOOD AGREEMENT WITH PHYSICIAN SAMPLING FOR DETECTING CHLAMYDIA/GONORRHEA


Recent research has recommended diagnosing chlamydia and gonorrhea through self-collected vaginal swabs than health professional collected endocervical swabs and first catch urine, with the latter two methods missing up to 10% of STIs in women. 

A comparison of self-collected samples using the HerSwab ™device to physician-collected samples using Aptima swabs in 189 women proved HerSwab™ devices to be suitable for the diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae. The study was conducted by McMaster University and St. Joseph’s Healthcare Hamilton and evaluated HerSwab™ compared to a physician collected sample for c. trachomatis and N. Gonorrhoeae by Aptima Combo 2 assay testing. The study demonstrated that HerSwab™ was comparable to a physician sample (94.7% agreement). 


EASE OF USE, ACCEPTABILITY AND PREFERENCE


Completed surveys from participants in the McMaster study found that 93% of women found the HerSwab 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. 


PARTICIPATION IN AN UNDERSCREENED POPULATION


A randomised controlled HPV self-sampling study was implemented in Slovenia with the aim to increase participation of non-responders to the organised population based cervical cancer screening programme, ZORA. The objective of this analysis is to assess the acceptance of HPV self-sampling among Slovenian non-responders and association of response rate with a type of self-sampling device. Non-responders aged 30−64 were randomly sampled from the national screening registry. They were allocated to the control arm (C) and two intervention arms for HPV self-sampling at home: I1 (n = 14,400, opt-in) and I2 (n = 9,556, opt-out) with a control group P (n=2,600). Women in I2 were randomly allocated to three groups I2-Q (n = 3,284), I2-H (n = 3,284) and I2-D (n = 2,988). Women who did not opt-out for self-sampling received one of three self-sampling devices (testers): women in I2-Q received Qvintip® (tester Q, Aprovix AB; Uppsala, Sweden), women in I2-H received HerSwab™ (tester H) and women in I2-D received Delphi Screener (tester D, Rovers Medical Devices, Netherlands). The study concluded that HPV self-sampling is accepted by Slovenian non-responders. Results from this pilot outlined that response rates for a reminder letter was 18.4% (response rates for (opt-out) self-collection with devices including HerSwab™ was 37.7%). Data presented in June 1016 at the Eurogin conference found that women using HerSwab™ had higher participation than Qvintip, and women using HerSwab™ and Qvintip had significantly higher participation than the Delphi Bioscreener.  


DRY SAMPLE STABILITY


A study conducted in Bogotá, Colombia evaluated samples collected with HerSwab™ compared with a physician collected sample, and HerSwab™ samples processed immediately (t=0, n=48) with HerSwab™ samples processed after 14 days at room temperature (t=14, n=45). The study found that HerSwab™ samples were comparable to physician samples (see Figure 4), and there was no significant degradation of HerSwab™ samples after 14 days (see Figures 6 and 7). Samples were processed on the Abbott Real Time High Risk HPV assay. Correlation between samples taken by physician vs HerSwab was Kappa 0.86 (CI 95% : 0.71-0.960. The study also found that there was a similar viral DNA present when processing HerSwab on t=0 compared to t=14 two weeks later, with the mean differences -0.34 cycles (CI 95% : -2.29 to 1.61). 

Another study looked at the suitability of samples collected with HerSwab™ for microbiome profiling. Although HerSwab™ absorbs less specimen than nylon swabs, as reflected in lower DNA concentrations in swab extracts and lower bacterial concentrations, enough cells are collected by HerSwab™ to yield sufficient high-quality DNA for deep sequencing analysis. They have been determined to provide reproducible, molecular profiles that are consistent with those from nylon swab samples. Additionally, samples kept at room temperature for 7 days exhibited only minor variations in proportional microbiome profile to those kept refrigerated at -80 degrees Celsius. 


Eve Kit & Your Clinic

A collaborative approach to a better patient experience

We work directly with healthcare partners to deliver a better experience to your patients. We want to work with healthcare professionals who have an interest in:

  • Innovation and technology
  • Patient-experience focused care
  • Collaborative parternships with industry

Eve Medical works with healthcare partners in many ways. This can range from medical advisory, being a medical services provider, or retail partner.

If any of this sounds interesting to you, we'd love to talk! Get in touch with us at: 1 (888) 635-9559 or support@eve-medical.com

Research Partnerships

Exploring better ways to screen

Eve Medical works closely with research and academic institutions to further our understanding of sexual health, health sampling, epidemiology and more. Eve Medical has worked with research institutions globally and is proud to support evidence-backed healthcare.

Eve Medical offers research pricing programs for academic and government institutions. If you are part of a research organization looking to use the Eve Kit Service or HerSwab™ device in your projects, get in touch with us at: 1 (888) 635-9559 or support@eve-medical.com

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