Clinical Evaluation of i-STAT Analyzer Glucose, Hematocrit and Sodium for Capillary Samples
Completed
- Conditions
- Analytical Performance of Sodium, Glucose and Hematocrit Assays by the i-STAT 500 (Alinity) Analyzer
- Registration Number
- NCT02897154
- Lead Sponsor
- Abbott Point of Care
- Brief Summary
The objective of this study is to compare the performance of two i-STAT Analyzers in a Point-of-Care (POC) setting. The evaluation will be performed using a cartridge to test glucose, hematocrit and sodium on capillary specimens.
- Detailed Description
The clinical performance for glucose, hematocrit and sodium assays for capillary samples was evaluated for the investigational i-STAT 500 (Alinity) analyzer based on results of method comparison testing against the i-STAT 1W analyzer.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 297
Inclusion Criteria
- Subject is ≥ 18 years of age
- Subjects (or their legal representative) who are willing to voluntarily consent to the study
Exclusion Criteria
- There are no exclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glucose (mg/dL) levels Patient's blood is tested within 3 minutes of blood collection Data analysis
Hematocrit (%PCV) levels Patient's blood is tested within 3 minutes of blood collection Data analysis
Sodium (mmol/L) levels Patient's blood is tested within 3 minutes of blood collection Data analysis
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
Kentucky Clinical Trials Laboratory
🇺🇸Louisville, Kentucky, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States