Clinical Evaluation of Precision for the Potassium and Ionized Calcium Tests in 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: Capillary 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 Precision for the Potassium and Ionized Calcium Tests Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer for Capillary Specimens
Overview
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 test Capillary blood draw
Capillary whole blood specimens collected from fingerstick(s) will be collected from each enrolled subject with blood collection capillary tubes.
Primary outcome measures
- Precision assessment [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: NCT07287631 · CS-2025-0002