Method Comparison Study for Measuring Potassium (K) and Ionized Calcium (iCa) in Blood
- Conditions
- Potassium (K) & Ionized Calcium (iCa) in Capillary Whole Blood
- Interventions
- Diagnostic Test: Fingerstick blood draw
- Registration Number
- NCT06295835
- Lead Sponsor
- Abbott Point of Care
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 232
- Signed and dated consent form (if required by the IRB)
- ≥ 18 years of age
• Prior enrollment in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Method comparison for K and iCa Tests using capillary whole blood specimens. Fingerstick blood draw 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 collected from two separate fingersticks.
- Primary Outcome Measures
Name Time Method Performance comparison Up to 5 minutes Compare the performance of the ionized calcium (iCa) test using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the iCa test on a comparator device.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
University of Maryland (UMD)
🇺🇸Baltimore, Maryland, United States
Penn State University Hershey Medical Center (Hershey)
🇺🇸Hershey, Pennsylvania, United States
Eastside Research Associates (ERA)
🇺🇸Redmond, Washington, United States
Abbott Point of Care (APOC)
🇨🇦Ottawa, Ontario, Canada