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

Healthy.io

Status

Completed

Conditions

Urine Detectable Acute and Chronic Diseases

Treatments

Device: Urine analysis predicate device for professional user

Diagnostic Test: Dip Home-Based Dipstick Analyzer

Study type

Interventional

Funder types

Industry

Identifiers

NCT04466774

CTP-Healthy.io-01

Details and patient eligibility

About

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.

Enrollment

429 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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