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

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

200 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Tingting Xu

Lead sponsor

Eaglenos Sciences, Inc.

Sponsor institution