Evaluation of the Accuracy and Usability of the ACR | U.S. Urine Analysis Test System in the Lay User Hands

Healthy.io Ltd.250 enrolled

Overview

Eligible subjects meeting the pathological profile will be recruited at the designated site by the study personnel. Following subject consent, the subjects will be evaluated for eligibility based on their health condition and history. The ACR \| U.S. kit, in its original packaging, along with the ACR \| U.S. smartphone application will be provided to the subject in a simulated home- use environment. All subjects will be provided with a list of tasks to complete, including providing a urine sample and operating the ACR \| U.S. device on 2 mobile phones. After completing the test, the lay user will complete a post-test questionnaire. The study observer will also complete a questionnaire to collect information regarding the lay users' use of the ACR \| U.S. The device use will be compared with identified risks to determine if the percentage of failures is acceptable. Additionally, measurable usability criteria for specific, critical steps will be evaluated. Following the usability test performed by the lay user, the subjects' urine samples will be tested by the study staff using the comparator device. These results will be considered as the "true value".

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

250

Conditions

Albuminuria

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Males and Females 18-80 years of age. * Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of albumin: * Diabetes Type I/Type II, * Hypertension, * any kidney disease, * other relevant conditions, * or, subjects who are healthy or pregnant. * Subject is familiar with the use of a smartphone. * Subject is capable of comprehending and following instructions in English. * Subject has facility with both hands. * Subject is capable and willing to adhere to the study procedures. * Subject is capable and willing to provide informed consent. Exclusion Criteria: * Subject has dementia. * Subject has severe mental disorders. * Subject cannot collect urine in a receptacle. * Subject is visually impaired (cannot read the user manual). * Any additional reason the study physician believes disqualifies the subject from participating in the study.

Outcomes

Primary Outcomes

Accuracy Evaluation: The Degree of Agreement (%) of the ACR | U.S. Urine Analysis Test System as Compared to the Comparator Device

The primary objective of the study is to evaluate the % exact match (percent agreement) and the % ±1 block match (percent agreement) of ACR \| U.S. Urine Analysis Test System (tested by the lay user) compared to the URiSCAN Optima Urine Analyzer (the comparator device, tested by a healthcare professional user), for all reported values (blocks). Different concentrations reported by the ACR \| U.S. Urine Analysis Test System were compared with results from the comparator device.

Time frame: 2 months

Secondary Outcomes

Usability Evaluation: User Performance Analysis

The usability of the ACR \| U.S. Urine Analysis Test System was determined by evaluating the percentage of study subjects able to perform all required steps and successfully complete the test given only the instructions and training materials provided. In addition, each subject was asked to complete a post test questionnaire to assess the device ease of use by rating the various test steps on a scale of 1 to 5, with 5 being the easiest ("very easy") and 1 the hardest ("very hard"). This questionnaire also included understanding questions in a multiple-choice, quiz-like format, to assess the participants' understanding of essential information and key test procedures in the study.