Clinical Evaluation of Potassium and Ionized Calcium Tests Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer for Capillary Specimens
Abbott Point of Care
Summary
The objective of this study is to compare the performance of blood tests using the i-STAT 1 System against a comparator blood analysis system.
Description
To compare the performance of the i-STAT potassium (K) and ionized calcium (iCa) tests using the i-STAT CG8+ cartridge on the i-STAT 1 analyzer to the performance of K and iCa tests on a comparator blood analysis system using results from two separate capillary specimens from each subject enrolled in the study.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Signed and dated consent form (waiver/alteration of consent, waiver of documentation of consent may be acceptable, per IRB) 2. ≥ 18 years of age Exclusion Criteria: 1\. Previous enrollment in this study
Interventions
- Diagnostic TestBlood draw
Capillary whole blood specimens collected from fingerstick(s) from each enrolled subject using blood collection capillary tubes.
Locations (3)
- University of New MexicoAlbuquerque, New Mexico
- Penn State Health Milton S. Hershey Medical Center (Hershey)Hershey, Pennsylvania
- Medical College of WisconsinMilwaukee, Wisconsin