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
Qualifiers
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 design
Treatments tested in this trial
- Reference Creatinine Test System(Cobas c 111)
- Investigational Creatinine Test System (EG)
Treatment groups
Locations
Sponsors and collaborators
Tingting Xu
Lead sponsor
Eaglenos Sciences, Inc.
Sponsor institution