Hematologic Tests
Conditions
Keywords
Potassium (K) and ionized calcium (iCa)
Brief summary
Assess precision of the i-STAT potassium (K) and ionized calcium (iCa) tests using i-STAT CG8+ cartridge on the i-STAT 1 analyzer.
Detailed description
The objective of this study is to assess the precision of the i-STAT K and iCa tests using the IUO i-STAT CG8+ cartridge on the i-STAT 1 analyzer using results from two separate capillary specimens from each subject enrolled in the study.
Interventions
DIAGNOSTIC_TESTCapillary blood draw
Capillary whole blood specimens collected from fingerstick(s) will be collected from each enrolled subject with blood collection capillary tubes.
Sponsors
Abbott Point of Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
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 |
|---|---|---|
| Precision assessment | Thirty (30) minutes from subject enrollment to the end of the blood draw and testing. | Assess the precision of the i-STAT potassium (K) and ionized calcium (iCa) tests in mmol/L with the investigational use only (IUO) i-STAT CG8+ cartridge on the i-STAT 1 analyzer using results from capillary specimens from each subject enrolled in the study. |
Countries
United States
Contacts
Primary ContactMiranda Gonzalez Aguirre, PhD
Outcome results
None listed