Glucose Intolerance, Hematuria, Ketone Urine, Proteinuria, Urinary Tract Infections
Conditions
Brief summary
This study will test Scanadu Urine Device for clinical performance and usability.
Detailed description
The objectives of this study are to: * Evaluate and validate the clinical performance of the Scanadu Urine Device in the hands of intended users as compared to: the visual read of chemical test strips performed by lab technicians utilizing the Siemens Multistix® 10SG technology (K905396). * Evaluate and validate the user-interface of the Scanadu Urine Device by the intended users for human factors and user interface of the Scanadu Urine Device. * Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels
Interventions
DEVICEScanadu Urine Device
Device to allow lay user to perform urinalysis test at home.
Sponsors
Scanadu, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female and male * 18 years old or older * Pregnant or not pregnant * Must have experience using an Apple iPhone * Have no visual impairments * Able to hold Smart Phone horizontally in raised dominant hand * Must be able to read and understand English * Must provide Informed Consent
Exclusion criteria
* Has a known history of a visual impairment that may affect reading and navigating the Scanadu Urine app * Unable to void and collect urine specimen for testing * Unable to hold phone steady (horizontally) or has history of tremors or conditions such as Parkinson's disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability: % successful scans in three tests conducted by lay users in following the app on the iPhone and obtain user experience on questionnaire | Single visit in one day | Evaluate and validate the user-interface of the Scanadu Urine Device by the intended users for human factors and user interface of the Scanadu Urine Device. |
| Method Comparison: Conduct two tests by following iPhone app (self and patient samples), results in concordance with professional testers; achieve accuracy in different concentrations of six urine analytes each using approximately 20 samples per level. | Single visit in one day | Evaluate and validate the clinical performance of the Scanadu Urine Device in the hands of intended users as compared to: the visual read of chemical test strips performed by lab technicians utilizing the Siemens Multistix® 10SG technology (K905396). |
| Reproducibility: Lay user's ability to repeat a urine test nine times by following iPhone app and obtain nine results that are in concordance. | Single visit in one day | Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels |
Countries
United States
Contacts
Primary ContactJenny Li
Backup ContactDaya Ranamukhaarachchi
Outcome results
None listed