Albuminuria
Conditions
Brief summary
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.
Interventions
DEVICEACR | U.S. Urine Analysis Test System
Each study participant will test their urine sample using the ACR \| U.S. test device - a home-use device intended for the semi-quantitative measurement of ACR in the urine (albumin and creatinine ratio) and used to aid in the management of kidney health.
DEVICEURiSCAN Optima Urine Analyzer
Upon completion of the test using the ACR \| U.S. device, each urine sample will be provided to a professional user for further urine analysis test using the comparator device, the URiSCAN Optima Urine Analyzer.
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy Evaluation: The Degree of Agreement (%) of the ACR | U.S. Urine Analysis Test System as Compared to the Comparator Device | 2 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability Evaluation: User Performance Analysis | 2 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
The study enrolled 250 subjects who met the inclusion criteria and performed a total of 546 tests at two U.S. clinical sites
Participants by arm
| Arm | Count |
|---|---|
| ACR | U.S. Urine Analysis Test System Urine samples are collected and tested by a lay user, using the new home use device. The lay user test results are compared to the results obtained by testing the same urine sample on the comparison device. | 250 |
| Total | 250 |
Baseline characteristics
| Characteristic | ACR | U.S. Urine Analysis Test System |
|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 17.43 |
| Concomitant Medications No Use of Concomitant medication(s) | 101 Participants |
| Concomitant Medications Use of one or more Concomitant medication(s) | 149 Participants |
| Education Attainment 9 to 12 years of education | 27 Participants |
| Education Attainment Less than 9 years of education | 1 Participants |
| Education Attainment Over 12 years of education | 221 Participants |
| Education Attainment Unknown | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 241 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Medical Background Diabetes Type II | 45 Participants |
| Medical Background Healthy | 139 Participants |
| Medical Background Heart disease | 8 Participants |
| Medical Background Hypertension | 96 Participants |
| Medical Background Kidney disease | 6 Participants |
| Medical Background Other | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 52 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 188 Participants |
| Sex: Female, Male Female | 139 Participants |
| Sex: Female, Male Male | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 250 |
| other Total, other adverse events | 0 / 250 |
| serious Total, serious adverse events | 0 / 250 |
Outcome results
Primary
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
Population: Each study participant was asked to perform the test twice: first, by using their preferred platform device (iOS or Android), in which usability and accuracy were evaluated; and secondly by using the other platform device, which was assessed for accuracy only. In addition, 23 spiked samples were used in order to achieve sufficient sample sizes for all analyte blocks, each sample on both platforms as well.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| ACR | U.S. Urine Analysis Test System | Accuracy Evaluation: The Degree of Agreement (%) of the ACR | U.S. Urine Analysis Test System as Compared to the Comparator Device | Overall - ACR Exact Agreement | 506 Tests |
| ACR | U.S. Urine Analysis Test System | Accuracy Evaluation: The Degree of Agreement (%) of the ACR | U.S. Urine Analysis Test System as Compared to the Comparator Device | Overall - ACR ± Block Match | 546 Tests |
| ACR | U.S. Urine Analysis Test System | Accuracy Evaluation: The Degree of Agreement (%) of the ACR | U.S. Urine Analysis Test System as Compared to the Comparator Device | Overall - Albumin Exact Agreement | 497 Tests |
| ACR | U.S. Urine Analysis Test System | Accuracy Evaluation: The Degree of Agreement (%) of the ACR | U.S. Urine Analysis Test System as Compared to the Comparator Device | Overall - Albumin ± Block Match | 546 Tests |
| ACR | U.S. Urine Analysis Test System | Accuracy Evaluation: The Degree of Agreement (%) of the ACR | U.S. Urine Analysis Test System as Compared to the Comparator Device | Overall - Creatinine Exact Agreement | 484 Tests |
| ACR | U.S. Urine Analysis Test System | Accuracy Evaluation: The Degree of Agreement (%) of the ACR | U.S. Urine Analysis Test System as Compared to the Comparator Device | Overall - Creatinine ± Block Match | 546 Tests |
Secondary
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.
Time frame: 2 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ACR | U.S. Urine Analysis Test System | Usability Evaluation: User Performance Analysis | Participants able to complete the device related tasks on 1st attempt | 250 Participants |
| ACR | U.S. Urine Analysis Test System | Usability Evaluation: User Performance Analysis | Overall ease of performing the test: very easy (5 out of 5) | 241 Participants |
| ACR | U.S. Urine Analysis Test System | Usability Evaluation: User Performance Analysis | Overall ease of performing the test: easy (4 out of 5) | 9 Participants |
| ACR | U.S. Urine Analysis Test System | Usability Evaluation: User Performance Analysis | Overall ease of performing the test: normal (3 out of 5) | 0 Participants |
| ACR | U.S. Urine Analysis Test System | Usability Evaluation: User Performance Analysis | Overall ease of performing the test: hard (2 out of 5) | 0 Participants |
| ACR | U.S. Urine Analysis Test System | Usability Evaluation: User Performance Analysis | Overall ease of performing the test: very hard (1 out of 5) | 0 Participants |
| ACR | U.S. Urine Analysis Test System | Usability Evaluation: User Performance Analysis | 1st understanding question: participants who answered correctly | 241 Participants |
| ACR | U.S. Urine Analysis Test System | Usability Evaluation: User Performance Analysis | 2nd understanding question: participants who answered correctly | 250 Participants |
| ACR | U.S. Urine Analysis Test System | Usability Evaluation: User Performance Analysis | 3rd understanding question: participants who answered correctly | 240 Participants |
| ACR | U.S. Urine Analysis Test System | Usability Evaluation: User Performance Analysis | 4th understanding question: participants who answered correctly | 249 Participants |
| ACR | U.S. Urine Analysis Test System | Usability Evaluation: User Performance Analysis | 5th understanding question: participants who answered correctly | 250 Participants |