Clinical Evaluation of i-STAT Analyzer Glucose, Hematocrit and Sodium for Capillary Samples

Abbott

Status: Completed

Conditions: Analytical Performance of Sodium, Glucose and Hematocrit Assays by the i-STAT 500 (Alinity) Analyzer

Treatments: Diagnostic Test: In-vitro

Study type: Observational

Funder types: Industry

Identifiers

NCT02897154

CS-2016-0003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 297 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design