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Multicenter Evaluation of 2 Vaginal Self-Collection Devices for HPV Testing
Shihai Huang1, Kevin Nelson1, Luciana Gentil1
1Molecular Diagnostics at Abbott, Des Plaines, IL.
Journal of Lower Genital Tract Disease
|April 1, 2026
Summary
New self-collection devices for human papillomavirus (HPV) detection show comparable clinical performance to clinician-collected specimens. This evaluation of vaginal swabs (simpli-COLLECT HPV swab and Evalyn Brush) supports their use in cervical screening.
Area of Science:
- Gynecologic Oncology
- Molecular Diagnostics
- Public Health Screening
Background:
- Human papillomavirus (HPV) testing is crucial for cervical cancer prevention.
- Self-collection devices offer a promising alternative to clinician-collected specimens for HPV detection.
- Standardizing and validating new self-collection methods is essential for clinical implementation.
Purpose of the Study:
- To evaluate the clinical performance of two vaginal self-collection devices (simpli-COLLECT HPV swab [SCS] and Evalyn Brush [EB]) compared to clinician-collected (CC) cervical specimens for HPV detection.
- To assess the agreement rates, clinical sensitivity, and specificity of HPV detection using self-collected versus clinician-collected specimens.
- To compare the performance of SCS and EB vaginal self-collection devices against each other.
Main Methods:
- A total of 1,763 women provided self-collected vaginal specimens using SCS and EB, alongside a clinician-collected cervical specimen (CC).
- All specimens were tested for high-risk HPV (HR HPV) using the Alinity m HR HPV assay.
- Positive and negative percent agreement (PPA, NPA), relative clinical sensitivity, and specificity were calculated to compare the devices.
Main Results:
- Positive percent agreement (PPA) between SCS and CC was 94.0%, and between EB and CC was 94.2%.
- Negative percent agreement (NPA) between SCS and CC was 86.0%, and between EB and CC was 88.4%.
- Relative clinical sensitivity for detecting cervical intraepithelial neoplasia grade 2 or worse (≥ CIN2) was comparable for both vaginal self-collection devices (1.00 for SCS, 1.02 for EB) versus CC specimens.
Conclusions:
- Both SCS and EB vaginal self-collection devices demonstrate clinical sensitivity comparable to clinician-collected specimens for detecting cervical disease (≥ CIN2) using the Alinity m HR HPV assay.
- High HPV agreement rates were observed between the self-collection devices and clinician-collected specimens, consistent with other validated methods.
- These findings support the clinical utility of SCS and EB for HPV detection in cervical screening programs.
