Potassium (K) & Ionized Calcium (iCa) in Capillary Whole Blood
Conditions
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.
Interventions
DIAGNOSTIC_TESTFingerstick blood draw
Capillary blood specimen collected from two separate fingersticks.
Sponsors
Abbott Point of Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Capillary whole blood specimens will be tested in duplicate on the i-STAT 1 Analyzer with the CG8+ cartridge and a blood analyte testing comparator device.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Signed and dated consent form (if required by the IRB) * ≥ 18 years of age
Exclusion criteria
• Prior enrollment in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance comparison | Up to 5 minutes | Compare the performance of the Potassium (K) test using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the K test on a comparator device. |
Countries
Canada, United States
Outcome results
None listed