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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-vitro | Diagnostic Test |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose (mg/dL) levels | Data analysis | Patient's blood is tested within 3 minutes of blood collection |
| Hematocrit (%PCV) levels | Data analysis | Patient's blood is tested within 3 minutes of blood collection |
| Sodium (mmol/L) levels | Data analysis | Patient's blood is tested within 3 minutes of blood collection |
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Inclusion Criteria:
Exclusion Criteria:
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Adults (18 years or older)
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| Name | Affiliation | Role |
|---|---|---|
| Chris P Edwards, BSc | Abbott Point of Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States | ||
| Kentucky Clinical Trials Laboratory |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 31, 2016 | Jan 17, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 4, 2016 | Mar 16, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D000096904 | In Vitro Meat |
| ID | Term |
|---|---|
| D008460 | Meat |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Louisville |
| Kentucky |
| 40202 |
| United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| D019602 |
| Food and Beverages |