The goal of the proposed research is to adapt and apply an existing nucleic acid (NA) amplification lab-on-a card platform to the specific identification of organisms responsible for common vaginal infections in patients presenting to primary health care settings in resource-limited settings. Component functions to be integrated into this platform include sample processing to support the direct use of self-collected clinical specimens and integrated parallel NA amplification and detection. This new, robust diagnostic test will provide clinicians with a rapid, highly sensitive, specific, easy-to-use, and cost-effective tool to detect vaginal infections at the point of care. In the five-year term of the proposed project, the following activities and milestones will be achieved:
Aim 1 : Selection, adaptation, and optimization of simple, robust, patient-obtained vaginal specimen collection methods and materials for diagnostic use in vaginal syndromes at the point of care. We will select three candidate sampling devices and comparatively evaluate their performance characteristics including NA collection and exfoliated cell counts among women presenting to a Seattle STD clinic.
Aim 2 : Development and optimization of an integrated parallel (NA) amplification lab-on-a-card diagnostic for the rapid identification of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and bacteria specific for bacterial vaginosis individually or simultaneously from a single clinical specimen. We will develop and validate all assay components including the specimen/card interface, on-card NA extraction and capture, NA amplification, and detection for each of the organisms of interest.
Aim 3 : Integration of sample processing, NA amplification, and detection onto a single, STI diagnostics lab-on-a-card. Individual assays developed in Aim 2 will be integrated to produce a single lab-on-a-card system. This system will provide rapid (the goal is 30 minutes) and accurate (the goal is 95% sensitivity and specificity compared to current gold standards) results while minimizing operator skill and equipment requirements to enable at or near point-of-care deployment.
Aim 4 : Use of archived and prospectively collected vaginal specimens to support diagnostic card development. At each stage of development we will use clinically collected specimens to evaluate the performance of the card and its components. After a functional, integrated card is developed, we will also carry out a prospective, preclinical evaluation of the unit to better assess its performance in the field. The proposed project will be conducted through a consortium agreement among four independent parties: Program for Appropriate Technology in Health (PATH);Micronics, Inc.;the University of Washington Center for AIDS and STD;and the Fred Hutchinson Cancer Research Center (FHCRC), Seattle, WA.
