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

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".

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Key information

Conditions

Albuminuria Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AccuMed research associates, Garden City, New York, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACR | U.S. Urine Analysis Test System

Device

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.

URiSCAN Optima Urine Analyzer

Device

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.

Primary outcomes

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

Time frame: 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 outcomes

Usability Evaluation: User Performance Analysis

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Healthy.io Ltd.

Industry

Registry information

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Nov 12, 2020
Registry last updated: May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed