Single-Step Endocervical and Ectocervical Balloon Collector

Background and Objectives: Despite recent advances, results of Pap tests remain relatively inaccurate, in part because of inadequate sampling. At present, optimal performance requires use of two devices in combination, spatula and brush, and the presence of endocervical and metaplastic cells within the collected specimen. To improve collection, we designed a novel type of cervical cell collector. Design and preliminary results: The InPath e2 Collector consists of a balloon that can be inflated against the ecto- and endocervical surfaces of the cervix. It is designed to capture in a single application cells from the entire surface of the cervix. Cells adhere to the balloon’s surface and can be released into conventional liquid-based preservative and analyzed by standard methods. In preliminary studies, the InPath e2 Collector was evaluated against the standard spatula/brush, in conjunction with ThinPrep preservative. The InPath e2 Collector was shown to be effective in obtaining representative samples of cervical cells, including endocervical and metaplastic cells. Conclusion: The InPath e2 Collector provides a novel single-step method for collection of exfoliated cervical cells; it has the potential for improved sampling of cervical cells and, therefore, for enhancing the accuracy of Pap testing in women.