Clinical Evaluation of Potassium and Ionized Calcium Tests Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer for Capillary Specimens
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Abbott Point of Care
- Enrollment
- 425
- Locations
- 3
- Primary Endpoint
- Method Comparison for potassium (K) and ionized calcium (iCa) blood tests.
Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Signed and dated consent form (waiver/alteration of consent, waiver of documentation of consent may be acceptable, per IRB)
- •≥ 18 years of age
Exclusion Criteria
- •1\. Previous enrollment in this study
Outcomes
Primary Outcomes
Method Comparison for potassium (K) and ionized calcium (iCa) blood tests.
Time Frame: Thirty (30) minutes from subject enrollment to the end of the blood draw and testing.
Specimen testing of K and iCa in mmol/L will be performed using the i-STAT CG8+ cartridge on the i-STAT analyzer and a comparator blood analysis system with prospectively collected capillary specimens. Subjects with one valid capillary result on the i-STAT CG8+ cartridge and one valid result on the comparator blood analysis system will be evaluated.
Secondary Outcomes
No secondary outcomes reported