Human papillomavirus testing using HPV APTIMA® assay and an external cellularity control in self-collected samples

Area of Science:

• Gynecologic Oncology
• Molecular Diagnostics
• Public Health Screening

Background:

• High-risk human papillomavirus (HR-HPV) detection is crucial for cervical cancer screening.
• Physician-collected and self-collected samples are utilized, necessitating reliable testing methods.
• Cellularity control (CC) is essential to minimize false-negative HR-HPV results.

Purpose of the Study:

• To evaluate the analytical performance of an external mRNA cellularity control (CC) for the HPV APTIMA® assay.
• To compare the CC's performance using physician-collected cervical samples versus self-collected vaginal samples.
• To assess the utility of CC in improving the reliability of HR-HPV testing.

Main Methods:

• An external mRNA CC was assessed for analytical performance on the PANTHER® automate.
• The CC was adjusted for cellular mRNA in ThinPrep® and Multitest® transport media.
• Results from 148 women using physician-collected and self-collected samples were compared.

Main Results:

• The CC is user-friendly but requires two independent assays.
• Self-collected vaginal samples showed lower median CC results (13.2 min vs. 16.9 min) and a higher risk of negative CC results (3.3% vs. 0%).
• The CC demonstrated effectiveness in controlling for cellularity in HR-HPV testing.

Conclusions:

• The systematic use of an RNA CC increases confidence in HR-HPV RNA assays, particularly for self-collected vaginal samples.
• Optimizing CC usefulness may involve defining a minimum cell number threshold to enhance confidence in HPV-negative results.
• The evaluated CC is a valuable tool for improving the accuracy of cervical cancer screening programs.