Precision Study Measuring Potassium (K) in Capillary Specimens

Not Applicable

Completed

• Conditions: Precision of Potassium (K) Test in Capillary Whole Blood

• Registration Number: NCT06291493
• Lead Sponsor: Abbott Point of Care

Brief Summary

Assessing precision of i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer.

Detailed Description

The objective of this study is to assess the precision of the i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer with investigational software using results from two (2) different fingerstick specimens from the same subject across the K measurement range.

Study Timeline

• Study First Submitted: 2024-02-26
• Study First Submitted QC: 2024-02-26
• Study First Posted: 2024-03-04
• Study Start: 2024-05-07
• Primary Completion: 2024-09-13
• Study Completion: 2024-09-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

• Signed and dated consent form (if required by the IRB)
• ≥ 18 years of age

Exclusion Criteria

• Prior enrollment in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Precision for Potassium (K) Test	Up to 5 minutes	Clinical Evaluation of Precision for the Potassium (K) Test in Capillary Specimens using the i-STAT CG8+ Cartridge with the i-STAT 1 Analyzer

Trial Locations

Locations (4)

University of Maryland, Baltimore (UMD); 🇺🇸 Baltimore, Maryland, United States

Penn State Health Milton S. Hershey Medical Center (Hershey); 🇺🇸 Hershey, Pennsylvania, United States

Eastside Research Associates (ERA); 🇺🇸 Redmond, Washington, United States

Abbott Point of Care (APOC); 🇨🇦 Ottawa, Ontario, Canada