Trial Outcomes & Findings for Evaluation of the Accuracy and Usability of the ACR | U.S. Urine Analysis Test System in the Lay User Hands (NCT NCT04626271)

Last Updated: 2023-05-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

250 participants

Primary outcome timeframe

2 months

Results posted on

2023-05-09

Participant Flow

The study enrolled 250 subjects who met the inclusion criteria and performed a total of 546 tests at two U.S. clinical sites

Unit of analysis: Tests

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	250 546
Overall Study COMPLETED	250 546
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ACR \| U.S. Urine Analysis Test System n=250 Participants 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.
Age, Continuous	57 years STANDARD_DEVIATION 17.43 • n=5 Participants
Sex: Female, Male Female	139 Participants n=5 Participants
Sex: Female, Male Male	111 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	241 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	52 Participants n=5 Participants
Race (NIH/OMB) White	188 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Education Attainment Less than 9 years of education	1 Participants n=5 Participants
Education Attainment 9 to 12 years of education	27 Participants n=5 Participants
Education Attainment Over 12 years of education	221 Participants n=5 Participants
Education Attainment Unknown	1 Participants n=5 Participants
Medical Background Hypertension	96 Participants n=5 Participants
Medical Background Diabetes Type II	45 Participants n=5 Participants
Medical Background Kidney disease	6 Participants n=5 Participants
Medical Background Heart disease	8 Participants n=5 Participants
Medical Background Healthy	139 Participants n=5 Participants
Medical Background Other	1 Participants n=5 Participants
Concomitant Medications Use of one or more Concomitant medication(s)	149 Participants n=5 Participants
Concomitant Medications No Use of Concomitant medication(s)	101 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ACR \| U.S. Urine Analysis Test System n=546 Tests 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.
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
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
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
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
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
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ACR \| U.S. Urine Analysis Test System n=250 Participants 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.
Usability Evaluation: User Performance Analysis Participants able to complete the device related tasks on 1st attempt	250 Participants
Usability Evaluation: User Performance Analysis Overall ease of performing the test: "very easy" (5 out of 5)	241 Participants
Usability Evaluation: User Performance Analysis Overall ease of performing the test: "easy" (4 out of 5)	9 Participants
Usability Evaluation: User Performance Analysis Overall ease of performing the test: "normal" (3 out of 5)	0 Participants
Usability Evaluation: User Performance Analysis Overall ease of performing the test: "hard" (2 out of 5)	0 Participants
Usability Evaluation: User Performance Analysis Overall ease of performing the test: "very hard" (1 out of 5)	0 Participants
Usability Evaluation: User Performance Analysis 1st understanding question: participants who answered correctly	241 Participants
Usability Evaluation: User Performance Analysis 2nd understanding question: participants who answered correctly	250 Participants
Usability Evaluation: User Performance Analysis 3rd understanding question: participants who answered correctly	240 Participants
Usability Evaluation: User Performance Analysis 4th understanding question: participants who answered correctly	249 Participants
Usability Evaluation: User Performance Analysis 5th understanding question: participants who answered correctly	250 Participants

Adverse Events

ACR | U.S. Urine Analysis Test System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Danielle Jeddah (Director of Clinical Development) OR Jennifer Kachel Acobas (Director of RA)

Healthy.io

Phone: 0543111050, 0528345562

Email: [email protected], [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place