Objective: To determine the efficacy of a self-test device for obtaining vaginal/cervical samples for HPV DNA and cytologic testing.
Study design: We recruited 878 Appalachian women; 775 were able to submit a self-test sample and a provider-collected sample. Each specimen was assessed for cytologic abnormalities and for high-risk HPV infection.
Results: Specimen adequacy: 869 of 878 (99%) women had sufficient material for cytologic analysis in provider-collected samples compared to 771 of 775 (99%) self-collected specimens (p = NS). There was sufficient cellular material (DNA) for HPV testing in 724 of 834 (87%) provider-collected samples compared to 690 of 736 (94%) self-collected specimens (p <0.04). In the provider-collected samples, 654 of 869 (75%) women had endocervical cells compared to 103 of 771 (13%) self-collected specimens (p <0.001). HPV assessment: 142 (19%) had high-risk HPV DNA detected. Of those women, 28 (20%) had HPV infection detected on the provider-collected specimen only, 51 (36%) on the self-collected specimen only, and 63 (44%) had HPV DNA on both specimens.
Conclusion: Our device is sufficient to obtain an adequate number of epithelial cells for cytologic and HPV testing.