Nova Max Creatinine and EGFR Meter System

Nova Max Creatinine and EGFR Meter System - Evaluation

To assess the performance of the Nova Max Creatinine and eGFR assay in the hands of CLIA-Waived Point-of-Care users in at least three (3) distinct Point-of-Care clinical settings on venous, and capillary blood and compare the performance characteristics to a traceable laboratory reference method (the Siemens EXL creatinine determination).

To assess the Ease of Use of the Nova Max Creatinine and eGFR Meter System in the hands of the intended CLIA-Waived Point-of-Care users.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Acute Kidney Injury
• Intervention / Treatment: Diagnostic test: Creatinine, eGFR

Detailed Description

This study is designed to evaluate the performance of the NM Meter when used by CLIAW operators in terms of both accuracy to an established reference method and precision. CLIAW operators will receive no training or prompting on how to use the NM Creatinine and eGFR Meter, operating only using the instructions found in printed labeling materials (IFU, QRG, packaging).

In determining the accuracy of the device, subjects will be tested using the NM Creatinine and eGFR Meter alongside a central laboratory reference method and the results will be compared to one another. This portion of the study is referred to as Method Comparison.

In determining the precision of the device, multiple creatinine determinations will be made with the NM Creatinine and eGFR meter using both stabilized control materials (testing over the course of 20 days) and venous whole blood specimens (tested over the course of a single day). The difference between the multiple test results will determine the device's level of precision. This portion of the study is referred to as Precision.

• Study Type: Observational
• Enrollment (Actual): 360

Contacts and Locations

Study Locations

• United States
  • Florida
    • Medley, Florida, United States, 33166
      • South Florida Research Organization
    • Miami Gardens, Florida, United States, 33169
      • Excellence Medical Research
    • Miami Lakes, Florida, United States, 33014
      • Charisma Medical and Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects will be identified via medical records for history of CKD or compromised kidney function and contacted to participate in this study. Study site personnel will provide details regarding the study (requirements, test procedure, subject rights) to obtain informed consent from the subject.

Potential subjects will be screened using the protocol inclusion and/or exclusion criteria. Adult subjects (≥ 18 years of age) with creatinine levels spanning the entire AMR of the NM Creatinine and eGFR Meter will be recruited for the study.

Description

Inclusion Criteria:

1. Adult males or females (≥ 18 years of age)
2. CKD Stage 1 (healthy)
3. CKD Stages 2-4
4. Subjects willing and able to consent to participating in the study.
5. Subjects whose pre-screen creatinine and eGFR value, if performed, is deemed valuable to the study.

Exclusion Criteria:

1. Subjects unable to consent to participating in the study.
2. Subjects possessing a cognitive disorder or other condition, which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analytical verification of Nova Max creatinine and eGFR meter system - Creatinine comparison	Nova Max creatinine and eGFR meter system, a point of care testing instrument is as effective as a reference laboratory method for Creatinine blood results in mg/dL	20 days
Analytical verification of Nova Max creatinine and eGFR meter system - eGFR comparison	Nova Max creatinine and eGFR meter system, a point of care testing instrument is as effective as a reference laboratory method for eGFR blood results in mL/min/1.73 m^2	20 days

Collaborators and Investigators

• Sponsor: Nova Biomedical
• Collaborators: South Florida Research Organization; Charisma Medical and Research Center; Excellence Medical Research
• Investigators: Principal Investigator: Giralt Yanez, South Florida Research Organization; Principal Investigator: Eduardo Alvarez, Charisma Medical and Research Center; Principal Investigator: Jeremy Bleicher, Excellence Medical Research

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2021
• Primary Completion (Actual): April 15, 2024
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: POCT; eGFR; Creatinine
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Acute Kidney Injury; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: NB21-eGFR-NA-FDA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes