The goal of this observational study is to evaluate the feasibility and usability of at-home urine sample collection, preparation, and smartphone imaging using the EcoExposure™ platform in adults. The main questions it aims to answer are:
Can participants successfully collect, prepare, and photograph urine samples at home and upload the images using a smartphone app? How consistent is image quality and participant adherence across repeated sampling over approximately 12 weeks? What is the short-term day-to-day variability in optical signals during an intensive daily sampling period?
Participants will:
Complete electronic consent and a brief intake questionnaire Collect and prepare urine samples at home at scheduled timepoints Capture guided smartphone photographs of the prepared samples Upload the images and provide brief feedback through the TrialKit app Optionally add a small reference solution (spike sample) to one sample for technical evaluation only
The study is fully remote and lasts approximately 12 weeks. It is intended for product development and workflow validation purposes only and does not involve any diagnostic or clinical decision-making.
Adults aged 18 years or older
Able to provide electronic informed consent
Willing and able to collect and prepare urine samples at home according to study instructions
Own a smartphone capable of running the TrialKit application and capturing photographs
Unable or unwilling to perform the study procedures (urine collection, sample preparation, smartphone imaging, and data upload)
Any condition or circumstance that, in the judgment of the investigator, would prevent the participant from successfully completing the study protocol
Adults aged 18 years and older who are willing and able to collect and prepare urine samples at home, capture smartphone photographs of the prepared samples, and upload the images through a mobile application. Participants may have common medical conditions; the ability to complete the study procedures is the primary requirement.
Cohort
Prospective
Not listed
Percentage of Scheduled Study Visits Completed by Participants
Percentage of all scheduled study visits completed by each participant during the 84-day study, including the daily sampling period on Days 7-14.
Percentage of Completed Study Visits With All Required Study Data
Percentage of completed study visits containing all required study data, including recording required urine sample information and uploading images to the secure study app. This measure will be used to assess the feasibility of the decentralized at-home study workflow.
Percentage of Uploaded Urine Sample Images Meeting Predefined Image Quality Criteria
Percentage of uploaded urine sample images that meet predefined image quality criteria for analysis using the EcoExposure™ image-analysis method.
Participant Rating of Ease of Using the At-Home Urine Collection and Imaging Workflow
Participants will rate the ease of using the at-home urine collection and imaging workflow on a 5-point rating scale from 1 to 5, with higher scores indicating greater ease of use.
Change in EcoExposure™ Microplastic and Nanoplastic Optical Measurements During Daily Urine Sampling
Urine samples will be measured using the EcoExposure™ optical assay and an image-analysis method that analyzes photographs of the samples. The study will compare how microplastic- and nanoplastic-related optical measurements change within the same participant during daily urine sampling (Days 7-14).
Difference in EcoExposure™ Optical Measurements Between Native and Microplastic/Nanoplastic-Spiked Urine Samples
When the optional spiked sample (urine sample where additional microplastic solution is added to the urine sample using an eyedropper) is performed, the participant's native urine sample and the spiked urine sample will be measured using the EcoExposure™ optical assay and image-analysis method. Optical measurements from the native and spiked samples will be compared to evaluate differences in assay response at different microplastic and nanoplastic levels.
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