Clinical Evaluation of i-STAT Analyzer Glucose, Hematocrit and Sodium for Capillary Samples
| Status: | Completed |
|---|---|
| Conditions: | Anemia, Endocrine, Hematology, Diabetes |
| Therapuetic Areas: | Endocrinology, Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | May 10, 2016 |
| End Date: | March 15, 2017 |
Clinical Evaluation of i-STAT Analyzer for Glucose, Hematocrit and Sodium
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.
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.
evaluated for the investigational i-STAT 500 (Alinity) analyzer based on results of method
comparison testing against the i-STAT 1W analyzer.
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
We found this trial at
3
sites
9500 Euclid Avenue
Cleveland, Ohio 44106
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Eric Anderson, MD
Phone: 216-444-0231
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201 East Jefferson Street
Louisville, Kentucky 40202
Louisville, Kentucky 40202
Principal Investigator: Saeed A Jortani, PhD
Phone: 502-569-0337
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Walnut creek, California 94598
Principal Investigator: Mark Christiansen, MD
Phone: 925-930-7267
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