Benefits found for self-collected cervical cancer screening

Benefits found for self-collected cervical cancer screening | Image Credit: © SewcreamStudio – © SewcreamStudio – stock.adobe.com.

A self-collected (SC) cervical cancer screening device is easy to use and preferred to a clinician-collected (CC) sample, according to a recent study published in JAMA Network Open.¹

Concerns over collection

The FDA approved high-risk human papillomavirus (hrHPV) testing in 2014, after which this method was recommended by the US Preventive Services Task Force (USPSTF). However, this method has traditionally required an in-clinic speculum examination, leading to barriers such as access to a clinic. This has led to updated USPSTF guidelines including an option for SC screening.²

“While prior studies have found high acceptability and usability for SC sampling in the at-home setting, the performance of samples stored without media or preservative (ie, dry swab) required for safe use at-home has shown lower sensitivity and agreement compared with samples collected by a clinician,” wrote investigators.¹

The Self-Collection for Cervical Cancer Screening study was conducted to assess the agreement of dry swab samples obtained with the Teal Wand SC device. Patients aged 25 to 65 years with an intact cervix were included in the analysis.

Sample collection and testing procedure 

Study groups included a general screening population and an enriched group comprised of patients with a positive hrHPV diagnosis or abnormal Papanicolaou cytology result within the prior 6 months. Patients who were pregnant or had vaginal bleeding or a cervical alteration in the past 5 months were excluded from the analysis.

After being taught how to use the SC device, patients performed the collection in a private area provided by the researchers. The collection sponge was placed in an empty vial and compared with a sample collected by a clinician using a Rovers Cervex-Brush (Rovers Medical Devices B.V.).

The Roche cobas hrHPV test was used to test SC and CC samples. Assessments were performed for 14 hrHPV types, including HPV-16, HPV-18, and 12 other hrHPVs. Patient covariates included income, race and ethnicity, education, screening preferences, and prior cervical screening history.

Key findings and diagnostic accuracy

There were 599 paired SC-CC samples included in the analysis, with a follow-up compliance rate of 98.2%. Of SC results, 2.3% were invalid, vs 0.5% of CC results. No prevailing cause was reported for these invalid samples. A positive percentage agreement (PPA) of 95.2% was reported for any of the 14 hrHPVs.

A colposcopy with a biopsy or excisional procedure was performed in 245 participants, and an excisional procedure was performed in an additional 19. High-grade squamous intraepithelial lesions or cervical intraepithelial lesion grade 2 or higher (CIN2+) were reported in 48 patients.

SC had an absolute clinical sensitivity of 95.8% for CIN2+, with a relative sensitivity of 1.00 compared with CC. For cervical intraepithelial lesion grade 3 or higher, these values were 96.6% and 0.97, respectively.

Safety and preference

When evaluating the cervix and vagina after use of the SC device, clinicians only identified 2 adverse events linked to the device. This included a minor cervical abrasion event and a spotting after collection event. The device had high user comprehension, with 92.3% of patients indicating easy or very easy understanding.

Delaying their screening was reported by 31.9% of patients, with common reasons including being uncomfortable with the examination, not having time, and financial issues. At-home SC was preferred by 45.8% of participants, in-clinic speculum collection by 34.2%, and in-clinic SC by 19.6%.

Nearly 86% of participants indicated they would be more likely to stay up to date on screening if at-home options were available. Overall, the SC device was safe, accurate, and preferred among the study population.

“The intersection of increased health autonomy and highly sensitive diagnostic tools makes this an optimal time to implement at-home SC cervical cancer screening in the US, thereby improving access and accelerating progress toward cervical cancer elimination,” wrote investigators.

References

1. Fitzpatrick MB, Behrens CM, Hibler K, et al. Clinical validation of a vaginal cervical cancer screening self-collection method for at-home use: A nonrandomized clinical trial. JAMA Netw Open. 2025;8(5):e2511081. doi:10.1001/jamanetworkopen.2025.11081
2. US Preventive Services Task Force. Screening for cervical cancer: US Preventive Services Task Force recommendation statement. JAMA. 2018;320(7):674–686. doi:10.1001/jama.2018.10897