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Related Concept Videos

Genital Herpes01:23

Genital Herpes

Genital herpes is a sexually transmitted infection primarily caused by herpes simplex virus type 2 (HSV-2), though herpes simplex virus type 1 (HSV-1) is increasingly implicated in genital infections, particularly among younger populations. Transmission occurs mainly through sexual contact, with asymptomatic viral shedding serving as a major route of spread. This characteristic makes HSV-2 difficult to control at a population level, as individuals may unknowingly transmit the virus even in the...

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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
PubMed
Summary
This summary is machine-generated.

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.

Keywords:
HPVcervical cancerprimary screeningself-collection

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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.