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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02897154

Enrollment

297

Registered

2016-09-13

Start date

2016-05-10

Completion date

2017-03-15

Last updated

2018-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTIn-vitro

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026