Screening With Tampons: Evaluating Diagnostic Accuracy and HPV and Assessing Participant Views

The DAYE Diagnostic Tampon is a class A in vitro diagnostic device. It has CE certification (self-certified via a declaration of conformity, following the IVDR (EU) 2017/746). The DDT is constructed entirely from woven cotton and consists of an absorbent core wrapped in a protective sleeve. The DDT is loaded in an applicator to aid with insertion.

A vaginal self-swab typically consists of a long, slender, and flexible stick or handle, often made of plastic or a similar material. At one end, there's a soft, absorbent tip made of cotton or synthetic material. This tip is designed to collect a sample from the vaginal walls or cervix.

"A clinician vaginal swab is a medical tool used by healthcare professionals to collect samples from the vaginal canal for diagnostic purposes. It's typically a long, thin, and flexible instrument. At one end, there's a cotton, rayon, or synthetic tip designed to collect cells, discharge, or other materials from the vaginal walls, cervix, or other areas within the vaginal canal.~The clinician swab is not taken in sub-study participants."