Urine Detectable Acute and Chronic Diseases
Conditions
Brief summary
The Dip Home-Based Dipstick Analyzer (henceforth HBDA) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environment. All subjects will be asked to complete the urine test by following the application guidance, including providing a urine sample and scanning the urine strip after placing it on the Color-Board. The user will also complete a questionnaire to collect information regarding the use of the HBDA device. Following the usability test performed by the lay user, the subject's urine sample will be tested by the professional user using the comparator device. The use of the HBDA device will be evaluated for accuracy and identified risks. Additionally, measurable usability criteria for specific, critical steps will be evaluated.
Interventions
DEVICEExperimental: Dip Home-Based Dipstick Analyzer
Dip Home-Based Dipstick Analyzer The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures 10 urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.
Sponsors
Healthy.io Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women 18-80 years of age * Subjects who are healthy or pregnant; or * Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of one of the following urine analytes; Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes, and Nitrite * Subject is capable and willing to provide informed consent. * Subject has facility with both hands. * Subject is capable and willing to adhere to the study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the % agreement of the Dip HBDA, tested by the lay user, as compared to a comparator device, tested by a professional user. | 11 months |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the Dip HBDA usability success rate, by potential lay users under actual use conditions | 11 months |
Countries
United States
Outcome results
None listed