Home Self-Collection Equals Clinic Exam for HPV Screening

Medscape

20-05-2025

A self-collection (SC) device that could easily be used at home proved safe and accurate for cervical screening in the SELF-CERV prospective nonrandomized clinical trial, as reported in JAMA Network Open .
Known as the Teal Wand, the device was recently approved by the US Food and Drug Administration (FDA) for home use.
When compared with clinician-collected (CC) samples, SC specimens showed high positive agreement for detecting high-risk human papillomavirus (hrHPV) as well as equivalent sensitivity for cervical dysplasia. The patient-friendly device proved safe and easy to use.
Christine Conageski, MD, MSc
An at-home collection option is crucial to address clinic-related barriers to screening, according to Christine Conageski, MD, MSc, an associate professor of obstetrics and gynecology at University of Colorado Anschutz Medical Campus in Aurora, Colorado, and colleagues.
She noted that 13,000 new cases of cervical cancer — a preventable disease — are still being diagnosed annually in the United States, with rates rising especially in rural counties. 'In essence, cervical cancer in the US has become a disease of access: Access to vaccination, screening, and timely treatment,' Conageski told Medscape Medical News .
'We saw an urgent need to address this gap. Our study was driven by the hope that at-home screening could help remove long-standing barriers and bring screening directly to the people who need it most.' Of key significance is the FDA's approval of the device for in-home use. 'That distinction is critical — it moves screening beyond the clinic and into patients' hands, which is where we believe the next major gains in cervical cancer prevention will happen,' she said.
SELF-CERV Study
The trial used a comparison design that clinically validated the SC device to provide vaginal specimens for cervical screening in a diverse US population. It tested a dry swab device, a single-patient use, disposable unit consisting of biocompatible, medical-grade injection-molded polymer components about the diameter of a standard tampon. The wand is designed to be inserted into the vagina with one hand.
The trial included 599 individuals with paired SC and CC samples. The participants (age, 25-65 years; 57.8% White; 97.3% identifying as female) were recruited from 16 clinical sites, including both community and academic practices, from November 2023 to April 2024. Data were analyzed in 2024 from April to August.
Eligible participants collected a sample with the SC method, followed by a standard CC sampling. Participants were followed up for safety and completed usability and screening preference surveys.
Primary outcome measures were positive percentage agreement (PPA) and negative percentage agreement for the detection of hrHPV between the two sets of samples. Other study measures included clinical sensitivity for high-grade cervical dysplasia and usability.
Among the 582 evaluable paired samples, the PPA between SC and CC samples for the detection of hrHPV was 95.2% (95% CI, 92.1%-97.1%; n = 278 of 292), exceeding the PPA endpoint for cervical screening.
The absolute clinical sensitivity for the detection of high-grade cervical dysplasia was 95.8% (95% CI, 86.0%-98.8%; n = 46 of 48), equivalent to the CC sensitivity (relative sensitivity, 1.00).
More than 90% of participants said the device instructions were easy or very easy to understand and would choose SC if they knew the results were comparable with CC results.
Real-World Impact of At-Home Screening
The significance of a comfortable home-based alternative to the intrusive speculum exam is clear. According to recent research by Diane M. Harper, MD, MPH, MS, a professor in the Departments of Family Medicine and Obstetrics & Gynecology at the University of Michigan in Ann Arbor, Michigan, 'the speculum is a major source of trauma and invasion that women will not tolerate.'
Diane M. Harper, MD, MPH, MS
In her research, women described the speculum exam with words such as 'awful, miserable, embarrassing, dreadful, excruciatingly painful, humiliating, exposing, and scary.' SC, in contrast, was characterized as 'comfortable, private, discreet, simple, convenient, worlds better, and innovative.'
Self-sampling is also easier for women with vulvodynia, dyspareunia, vaginal atrophy, or urinary leakage, Harper added. Moreover, patients don't have to worry about clinic visits, transportation, time off work, and arranging care for children or elders at home. 'A host of inconveniences and barriers to the in-office exam are excluded by having an at-home option,' Harper said.
One potential downside to home screening, however, is that a sampling device could break off in situ preventing removal. 'If it's not painful, then the patient can wait for an appointment to have the device removed. If it is painful, then she must go to urgent or emergency care to have it removed,' Harper said.
She pointed out that private insurance carriers currently cover only 73% of their populations with appropriate cervical cancer screening, and those in federally sponsored care have 50% screening rates year over year. 'That means 30%-50% of US women are not being screened.'
The successful Cologuard home screening option for colon cancer may provide a workable model. Harper recommends a health-system approach to incorporating self-sampling into the cervical cancer screening of all screen-eligible people.
According to Conageski, the success of at-home screening will depend on thoughtful systems that support patients through the entire process — from test delivery to diagnosis and treatment. 'Simply sending someone an at-home test doesn't guarantee they'll complete it, return the sample, or have timely access to follow-up care if the result is positive,' she said. 'Community-based research and implementation science will be essential in building equitable, scalable models that ensure all individuals not only get screened but also receive the follow-up care they need.'
In her view, the next research phase needs to focus on real-world implementation. 'Teal's digital platform offers a unique opportunity to study how at-home screening performs outside of controlled settings — delivering timely results directly to patients and tracking what happens next.'
This study was supported by Teal Health, the National Institutes of Health, and Planned Parenthood.