Abstract
Objective:
This study evaluated the clinical performance of vaginal specimens collected using a new self-collection device and a well-established self-collection device, compared with cervical specimens collected by clinicians for HPV detection.
Methods:
A total of 1,763 women undergoing routine cervical screening or referred to colposcopy provided self-collected vaginal specimens, using simpli-COLLECT HPV swab (SCS) and Evalyn Brush (EB), and one clinician-collected (CC) cervical specimen. Specimens were tested with the Alinity m HR HPV assay, and the results were used to determine positive and negative percent agreement (PPA and NPA), relative clinical sensitivity and specificity.
Results:
For the combined populations (screening and referred to colposcopy), PPA and NPA between SCS and CC specimens were 94.0% and 86.0%, respectively, and between EB and CC specimens were 94.2% and 88.4%, respectively. The PPA and NPA between SCS and EB vaginal specimens were 95.5% and 93.7%. The relative clinical sensitivity for ≥ CIN2 between vaginal specimens and CC specimens was 1.00 and 1.02 for SCS and EB, respectively. The relative clinical specificity between vaginal specimens and CC specimens was 0.90 and 0.92 for SCS and EB specimens, respectively.
Conclusion:
This study is among the first US multicenter evaluations comparing 2 self-collection devices on the same molecular platform. It demonstrated that the clinical sensitivity of the Alinity m HR HPV assay for cervical disease detection (≥ CIN2) using both SCS and EB self-collected vaginal specimens is comparable to that in CC specimens. Overall, HPV agreement rates were consistent with those reported for other validated self-collected devices.