Validation of Vaginal Self-Sampling With the Abbott Multi-Collect Swab for HPV Screening in Women Aged 30 to 64 Years

Validation of Multi-Collect Device for Self-Sampling

This study evaluates the performance of HPV testing on vaginal self-collected samples obtained with the Abbott Multi-Collect device. The study compares HPV test results from self-collected vaginal samples with results from clinician-collected cervical samples in women aged 30 to 64 years who either participate regularly in cervical cancer screening or have not attended screening for at least 3 years. The goal is to determine whether self-sampling provides accurate detection of high-risk human papillomavirus (hrHPV) and could support broader participation in cervical cancer screening programs.

Human papillomavirus (HPV) testing is an important component of cervical cancer screening. Self-sampling may increase screening participation, particularly among women who do not regularly attend screening programs. The Multi-Collect Specimen Collection Swab (Abbott) is a self-sampling device that offers practical advantages for large-scale screening, including simplified sample handling and compatibility with automated laboratory workflows.

This single-center, observational, cross-sectional study evaluates the clinical performance of HPV testing on vaginal self-collected samples obtained using the Abbott Multi-Collect device. HPV test results from self-collected vaginal samples are compared with matched clinician-collected cervical samples obtained during the same visit. Samples are analyzed using the Alinity m HR HPV assay, the m2000 RealTime High Risk HPV Assay, and the RIATOL qPCR HPV genotyping assay.

The study includes women aged 30 to 64 years who either regularly participate in cervical cancer screening or have not attended screening for at least 3 years. The inclusion of screening non-attenders allows evaluation of test performance in a population that may particularly benefit from self-sampling approaches and provides a setting that reflects real-world implementation of HPV self-sampling.

The study aims to assess the relative clinical accuracy of HPV testing on self-collected versus clinician-collected samples and to evaluate agreement between different HPV assays. The findings are intended to support the clinical validation of the Abbott Multi-Collect device for vaginal self-sampling as a tool to help expand access to cervical cancer screening.

Inclusion Criteria:

• Women aged 30-64 years.
• Women that regularly attend screening with negative HR-HPV-result on the RIATOL assay at previous screen within the past 3 years OR women that did not attend screening during the past 3 years or longer.

Exclusion Criteria:

• Women treated for cervical cancer (hysterectomized).
• Pregnant women.
• Menstruating women
• Non-consenting women.
• Women unable to understand and/or sign informed consent.