Evaluation of Potassium (K) and Ionized Calcium (iCa) Tests Using Capillary Specimens
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood draw.
- Who it may be relevant to
- Registry conditions: Hematologic Tests. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Evaluation of Potassium and Ionized Calcium Tests Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer for Capillary Specimens
Overview
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 test Blood draw
Capillary whole blood specimens collected from fingerstick(s) from each enrolled subject using blood collection capillary tubes.
Primary outcome measures
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 3 centers
- University of New Mexico — Albuquerque
- Penn State Health Milton S. Hershey Medical Center (Hershey) — Hershey
- Medical College of Wisconsin — Milwaukee
Identifiers
NCT: NCT07287618 · CS-2025-0001