NCT05118074

Nova Max Creatinine and eGFR Meter System

Nova Max Creatinine and eGFR Meter System - Evaluation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 360 (actual)
• Sponsor: Nova Biomedical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Chronic Kidney Diseases
• Acute Kidney Injury

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Creatinine, eGFR	Compare diagnostic tests to reference methods

Timeline

• Start date: 2021-06-08
• Primary completion: 2024-04-15
• Completion: 2024-04-15
• First posted: 2021-11-11
• Last updated: 2025-03-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study