NCT06726460

Validation of the Accuracy of a Novel POCT Dry Electrolyte Analysis System in the Acute Care Setting

Validation of the Accuracy of a Novel POCT Dry Electrolyte Analysis System in the Acute Care Setting: A Cross-Sectional Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: Not accepted

Summary

The goal of this study is to compare the performance of a novel Point-of-Care Testing (POCT) dry electrolyte analyzer (P1) with the Nova Stat Profile pHOx Ultra Analyzer System (Nova) in an acute care setting. The main questions it aims to answer are: 1. How consistent are the results between P1 and Nova in the emergency setting, including outliers, correlation, linearity, and bias? 2. Whether P1 can serve as a suitable alternative to Nova in the acute care setting for electrolyte measurement in the emergency environment. Participants will be patients in the emergency department who will undergo simultaneous measurement with P1 and Nova during their emergency care to assess the performance of both devices. Additionally, the study will investigate electrolyte levels in emergency patients, focusing on the prevalence of abnormal ionized magnesium (iMg2+) levels, the correlation between iMg2+ and total magnesium (tMg), and the clinical significance of iMg2+ measurement.

Detailed description

This observational study aims to compare the performance of two electrolyte analysis systems, the electrolyte analyzer P1 and the Nova Stat Profile pHOx Ultra Analyzer System, in an emergency department (ED) or emergency intensive care unit (ICU) setting. The study will evaluate the consistency, correlation, and bias between the two electrolyte analysis systems. The study design is observational, with no intervention or treatment assigned to the participants. The comparison will be made using residual blood samples collected as part of routine care, following standard clinical procedures.

Conditions

• Electrolyte Disorder
• Arrhythmia
• Stroke

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Nova Stat Profile pHOx Ultra Analyzer System(Nova)	This group involves the use of Nova for measuring serum and whole blood samples. The results from Nova will be compared with those obtained from P1.
DIAGNOSTIC_TEST	Novel POCT dry electrolyte analysis system(P1)	This group involves the use of P1 for measuring serum and whole blood samples. The results from P1 will be compared with those obtained from Nova.

Timeline

• Start date: 2024-12-17
• Primary completion: 2025-08-31
• Completion: 2025-10-31
• First posted: 2024-12-10
• Last updated: 2025-07-18

Locations

1 site across 1 country: China