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

NCT07768787 | Completed FDA Device

• 2 other identifiers: R021-28CIV-24-05-047445
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Papilloma Virus; Human Papilloma Virus Related Cervical Carcinoma; Cervical Carcinoma

Keywords

Vaginal self-sampling; VALMUDES; Cervical Cancer Screening

Outcome Measures

Primary Outcomes (1)

• Relative Sensitivity and Specificity of High-Risk HPV Testing on Self-Collected Versus Clinician-Collected Samples

  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.

  From enrollment through completion of protocol-defined follow-up, up to 12 months

Secondary Outcomes (3)

• Agreement Between High-Risk Human Papillomavirus Assays

  At enrollment

• Absolute Sensitivity and Specificity for Detection of CIN2+

  From enrollment through completion of protocol-defined follow-up, up to 12 months

• Beta-Globin Positivity Rate

  At enrollment

Study Arms (2)

Regular Screening Attenders

Women aged 30 to 64 years who regularly participate in cervical cancer screening and had a negative high-risk human papillomavirus (hrHPV) result at their previous screening within the past 3 years.

Device: Abbott Multi-Collect Specimen Collection Swab

Screening Non-Attenders

Women aged 30 to 64 years who did not participate in cervical cancer screening during the previous 3 years or longer.

Device: Abbott Multi-Collect Specimen Collection Swab

Interventions

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.

Regular Screening Attenders; Screening Non-Attenders

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women attending a participating gynecology practice were recruited for this study. The population included women from a routine cervical cancer screening setting and women who had not recently participated in cervical cancer screening.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AML: lead

Study Sites (1)

O+ Medicale

Brussels, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

Residual vaginal self-collected samples and clinician-collected cervical samples are retained for future research. Vaginal samples are collected using the Abbott Multi-Collect swab and cervical samples are collected using the Rovers Cervex-Brush. Samples are stored in a coded manner, including residual specimens stored at -80°C. These samples contain human cellular material and may be used for DNA-based molecular analyses, including human papillomavirus (HPV) testing and related research.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start: September 19, 2024
• Primary Completion: July 6, 2026
• Study Completion: July 31, 2026
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)