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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Consistency between P1 and Nova system for electrolyte parameters. — Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection
  This outcome measure is to evaluate the consistency between the novel POCT dry electrolyte analysis system (P1) and the Nova Stat Profile pHOx Ultra Analyzer System (Nova). Consistency will be assessed by comparing the results of electrolyte parameters (e.g., Sodium (Na+), Potassium (K+), Chloride (Cl-), Ionized calcium (iCa2+), Ionized magnesium (iMg2+)) and will be evaluated using Bland-Altman analysis.
• Correlation between P1 and Nova for electrolyte parameters. — Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection
  This outcome measures the correlation between P1 and Nova for electrolyte parameters (e.g., Na+, K+, Cl-, iCa2+, iMg2+). The correlation will be quantified using Pearson's correlation coefficient
• Bias at clinical decision levels between P1 and Nova. — Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection
  This outcome measure is to evaluate the bias at clinical decision levels between P1 and Nova. Bias will be assessed by calculating the difference in the results of key electrolyte parameters (e.g., Na+, K+, Cl-, iCa2+, iMg2+) between the two analysis system at clinically relevant thresholds. These thresholds will be based on established clinical decision points where treatment decisions are made.
• Outlier Detection in electrolyte Parameters — Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection
  This outcome measure aims to identify and evaluate outliers in the electrolyte parameters measured by P1 and Nova. Outliers will be detected using statistical methods such as the Grubbs test or the Interquartile Range (IQR) method. The impact of these outliers on the consistency and accuracy of the measurements will also be assessed.

Trial sites (1)

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