NCT05838872

Evaluation of the Accuracy and Usability of the Minuteful - Kidney Urine Analysis Test System in the Lay User Hands

Comparative, Controlled Study to Evaluate the Clinical Accuracy and Usability Performance of the Minuteful - Kidney Urine Analysis Test System Conducted by Lay Users

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Healthy.io Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to collect additional performance and clinical data on the Minuteful - Kidney test device (previously "ACR \| U.S. Urine Analysis Test System"), following the original data collection (NCT04626271). This method comparison and usability study was designed to evaluate the agreement levels of the Minuteful - Kidney Test with the comparator device (URiSCAN Optima) as well as the device's usability including the lay user's ability to understand and implement the device instructions. It also evaluates the ease of use of the device under actual use conditions in a simulated home environment.

Detailed description

Eligible subjects meeting the inclusion criteria were recruited at the designated site by the study personnel. Following subject consent, the Minuteful - Kidney test kit, in its original packaging, along with the Minuteful - Kidney smartphone application were provided to the subject in a simulated home- use environment. All subjects were requested to follow the in-app instructions to complete the test, without any guidance from the study staff before, during or after testing. After each subject completed the test, the urine sample was tested by a professional user at the clinical site on the URiSCAN Optima device. Each urine sample was tested twice: once using the Minuteful - kidney test by the lay user and once using the comparator device (URiSCAN Optina) by the professional user. To evaluate the usability of the device, study staff on-site were asked to observe and document the user performance on key tasks in the study flow as well as information regarding the user behavior while performing the test. Subjects were also asked to answer a usability post-test questionnaire.

Conditions

• Albuminuria
• Chronic Kidney Diseases
• Diabetes
• Hypertension

Interventions

Type	Name	Description
DEVICE	Minuteful - Kidney Urine Analysis Test System	Urine samples were collected and tested by a lay user, using the Minuteful - Kidney test device. The lay user test results were compared to the results obtained by testing the same urine sample on the comparison device, the URiSCAN Optima.

Timeline

• Start date: 2021-12-09
• Primary completion: 2022-02-28
• Completion: 2022-07-15
• First posted: 2023-05-03
• Last updated: 2023-05-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study