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

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.

• Abbott Multi-Collect Specimen Collection Swab (Device): Vaginal self-sampling device used for collection of self-collected vaginal specimens for high-risk human papillomavirus testing.

Primary outcomes

• Relative Sensitivity and Specificity of High-Risk HPV Testing on Self-Collected Versus Clinician-Collected Samples [From enrollment through completion of protocol-defined follow-up, up to 12 months]: Relative sensitivity and specificity of high-risk human papillomavirus (hrHPV) testing on vaginal self-collected samples compared with matched clinician-collected cervical samples using the Alinity m HR HPV assay, m2000 RealTime High Risk HPV Assay, and RIATOL qPCR HPV genotyping assay.

Secondary outcomes

• Agreement Between High-Risk Human Papillomavirus Assays [At enrollment]: Concordance of high-risk human papillomavirus (hrHPV) test results between the Alinity m HR HPV assay, m2000 RealTime High Risk HPV Assay, and RIATOL qPCR HPV genotyping assay on vaginal self-collected samples.
• Absolute Sensitivity and Specificity for Detection of CIN2+ [From enrollment through completion of protocol-defined follow-up, up to 12 months]: Absolute sensitivity and specificity of high-risk human papillomavirus testing on self-collected vaginal samples and clinician-collected cervical samples for the detection of underlying cervical intraepithelial neoplasia grade 2 or worse (CIN2+).
• Beta-Globin Positivity Rate [At enrollment]: Positivity rates of the beta-globin sample adequacy control in self-collected vaginal samples and clinician-collected cervical samples

Sex: Female, ages: 30 Years to 64 Years, accepts healthy volunteers

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.