NCT06295835

Method Comparison Study for Measuring Potassium (K) and Ionized Calcium (iCa) in Blood

Clinical Evaluation of the Potassium (K) and Ionized Calcium (iCa) Tests in Capillary Specimens Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: Abbott Point of Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Method comparison study for Potassium (K) and ionized calcium (iCa).

Detailed description

The objective of this study is to compare the performance of the K and iCa Tests using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the K and iCa Tests on the comparator device using capillary whole blood specimens. This objective will be assessed as part of a Method Comparison evaluation.

Conditions

• Potassium (K) & Ionized Calcium (iCa) in Capillary Whole Blood

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Fingerstick blood draw	Capillary blood specimen collected from two separate fingersticks.

Timeline

• Start date: 2024-05-31
• Primary completion: 2025-01-29
• Completion: 2025-01-29
• First posted: 2024-03-06
• Last updated: 2025-03-19

Locations

4 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study