Self-sampling with HPV mRNA analyses from vagina and urine compared with cervical samples

Area of Science:

• Gynecologic Oncology
• Molecular Diagnostics
• Public Health

Background:

• Cervical cancer screening coverage can be improved using self-sampling methods with human papillomavirus (HPV) analysis.
• Self-sampling offers a potential alternative to traditional clinician-collected samples.

Purpose of the Study:

• To compare the detection of HPV mRNA in self-collected vaginal and urine samples against clinician-collected cervical samples.
• To evaluate the diagnostic performance of HPV mRNA testing in self-samples compared to cytology and histological outcomes.

Main Methods:

• Analyzed 209 women's self-collected vaginal and urine samples, alongside clinician-collected cervical samples, using the Aptima HPV mRNA assay.
• Correlated HPV mRNA results with cervical cytology, colposcopy, biopsy, and loop electrosurgical excision procedure (LEEP) findings.

Main Results:

• Vaginal self-samples showed 85.5% sensitivity for detecting high-grade squamous intraepithelial lesions (HSIL)/adenocarcinoma in situ (AIS)/cancer, similar to routine cytology (81.7%).
• Clinician-collected cervical samples achieved 100% sensitivity, while urine samples had 44.8% sensitivity.
• Specificities were comparable between clinician-collected cervical samples (49.0%) and vaginal self-samples (48.1%), with cytology showing higher specificity (93.3%).

Conclusions:

• HPV mRNA testing of vaginal self-samples demonstrates sensitivity comparable to routine cytology for detecting HSIL/AIS/cancer.
• Aptima HPV mRNA vaginal self-sampling may serve as a valuable adjunct to existing cervical screening programs.
• Urine-based HPV testing showed significantly lower sensitivity and is less suitable for current screening paradigms.