Clinical Performance of a Point-of-Care Creatinine Testing System in Individuals With Kidney Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTingting Xu
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Abnormal creatinine levels or suspected kidney disease;
Aged 18 and above, gender is not limited;
Voluntarily participate in this clinical study by signing the informed consent form.
Disqualifiers
The HCT range is not within 25-65%;
Severe mental illness or other conditions that make the patient unable to cooperate;
Inability to read or write in English language;
Incomplete subject information (including but not limited to gender, age, education level, clinical diagnosis information; etc.);
Trial population
Include at least 80% patients with varying stages of non-dialysis dependent kidney disease, as well as a small group (e.g.\<20 %) of healthy volunteers and dialysis-dependent kidney disease patients, to cover the reference interval of the creatinine concentration. All subjects should be naive to this creatinine monitoring system and the similar self-monitoring devices (including but not limited to glucose, ketone, total cholesterol, etc.).
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Reference Creatinine Test System（Cobas c 111）
Diagnostic testThis group involves the use of the Cobas biochemical analyzer for measurement of venous plasma creatinine samples. The results obtained from Cobas will be compared with those obtained from the investigational Eaglenos Creatinine Test System to evaluate the accuracy and reliability of the investigational device. Study participant management and clinical care will not be influenced by the results of these study measurements.
Investigational Creatinine Test System （EG）
Diagnostic testThis group involves the use of the Eaglenos Creatinine Test System, a handheld device designed for self-testing of fingerstick capillary whole blood by laypersons with non-dialysis-dependent kidney disease. The results obtained from EG will be compared with those obtained from the Cobas biochemical analyzer to evaluate the accuracy and reliability of the investigational device. Study participant management and clinical care will not be influenced by the results of these study measurements.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Group 1: Cobas Group1 intervention
Group B: Group 2: EG Group1 intervention
Trial outcomes
Primary outcomes
1
Creatinine Concentrations Measured by the Eaglenos Creatinine Test System Compared With the Cobas c 111
Creatinine concentrations (mg/dL) will be measured in fingerstick capillary whole blood using the Eaglenos Creatinine Test System and in venous plasma using the Cobas c 111 analyzer. Agreement between the two systems will be assessed using Bland-Altman analysis.
Time frame
Day 0 (at the time of blood sample collection).2
Correlation of Creatinine Concentrations Between the Eaglenos Creatinine Test System and the Cobas c 111
Creatinine concentrations (mg/dL) measured by the Eaglenos Creatinine Test System (capillary whole blood) and the Cobas c 111 analyzer (venous plasma) will be assessed for linear correlation using Pearson's correlation coefficient (r).
Time frame
Day 0 (at the time of blood sample collection).3
Predicted Differences in Creatinine Concentrations at Predefined Medical Decision Levels Between the Eaglenos Creatinine Test System and the Cobas c 111
Creatinine concentrations (mg/dL) measured by the Eaglenos Creatinine Test System (capillary whole blood) and the Cobas c 111 analyzer (venous plasma) will be used to calculate predicted differences (predicted bias) at predefined medical decision levels using Passing-Bablok regression based on all paired measurements. These levels correspond to clinically relevant cut-off values for patient management.
Time frame
Day 0 (at the time of blood sample collection).4
Number of Outlier Measurements in Creatinine Concentration Between the Eaglenos Creatinine Test System and Cobas c 111
Outliers in paired creatinine measurements (mg/dL) from the Eaglenos Creatinine Test System (capillary whole blood) and the Cobas c 111 analyzer (venous plasma) will be identified using the Extreme Studentized Deviate (ESD) method. The frequency of outlier values will be reported.
Time frame
Day 0 (at the time of blood sample collection).Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tingting Xu
Lead sponsor
Eaglenos Sciences, Inc.
Sponsor institution
Source ClinicalTrials.gov
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