Clinical Performance of a Point-of-Care Creatinine Testing System in Individuals With Kidney Disease

The goal of this clinical performance study is to evaluate the accuracy and usability of the Eaglenos Creatinine Test System（referred to as EG）, a point-of-care testing (POCT) system that consists of a handheld device and its associated creatinine test strips, intended for home use by laypersons with non-dialysis-dependent kidney disease. The main questions it aims to answer are: 1. How consistent are creatinine measurements from the investigational creatinine test system compared with the clinical standard method? 2. How usable is the Creatinine Monitoring System for laypersons in a home setting? Researchers will compare creatinine results obtained with the investigational creatinine test system (fingerstick capillary whole blood) to those from a Cobas biochemical analysis system（referred to as Cobas) (venous plasma) to determine whether the investigational device provides accurate and reliable measurements. Participants will: 1. Provide a venous blood sample for comparative testing. 2. Perform self-testing using the Creatinine Monitoring System without prior training. 3. Complete a usability questionnaire about their experience with the investigational creatinine test system.

NCT Number	NCT07251075
Lead Sponsor	Tingting Xu
Conditions	Chronic Kidney Diseases, Kidney Injury, Acute
Enrollment	200 participants
Start Date	2025-11-30
Primary Completion	2025-12-30 (estimated)
Study Completion	2025-12-30 (estimated)
Updated on ClinicalTrials.gov	2025-11-26