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

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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.

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.

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
Walnut creek, California 94598
Principal Investigator: Mark Christiansen, MD
Phone: 925-930-7267
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Eric Anderson, MD
Phone: 216-444-0231
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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201 East Jefferson Street
Louisville, Kentucky 40202
Principal Investigator: Saeed A Jortani, PhD
Phone: 502-569-0337
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Louisville, KY
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