Hematologic Tests
Conditions
Keywords
Potassium (K) ionized calcium (iCa)
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.
Interventions
DIAGNOSTIC_TESTBlood draw
Capillary whole blood specimens collected from fingerstick(s) from each enrolled subject using blood collection capillary tubes.
Sponsors
Abbott Point of Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Method Comparison Study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Method Comparison for potassium (K) and ionized calcium (iCa) blood tests. | 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. |
Countries
United States
Contacts
Primary ContactMiranda Gonzalez Aguirre, PhD
Outcome results
None listed