A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer
A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer
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.
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