Precision Study Measuring Potassium (K) in Capillary Specimens

Abbott Point of Care161 enrolled

Overview

Assessing precision of i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer.

The objective of this study is to assess the precision of the i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer with investigational software using results from two (2) different fingerstick specimens from the same subject across the K measurement range.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

161

Conditions

Precision of Potassium (K) Test in Capillary Whole Blood

Interventions

Fingerstick blood drawDIAGNOSTIC_TEST

Capillary blood specimen collected from two separate fingerstick blood draws.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Signed and dated consent form (if required by the IRB) * ≥ 18 years of age Exclusion Criteria: • Prior enrollment in the study

Locations (4)

University of Maryland, Baltimore (UMD)

Baltimore, Maryland, United States

Penn State Health Milton S. Hershey Medical Center (Hershey)

Hershey, Pennsylvania, United States

Eastside Research Associates (ERA)

Redmond, Washington, United States

Abbott Point of Care (APOC)

Ottawa, Ontario, Canada

Outcomes

Primary Outcomes

Precision for Potassium (K) Test

Clinical Evaluation of Precision for the Potassium (K) Test in Capillary Specimens using the i-STAT CG8+ Cartridge with the i-STAT 1 Analyzer

Time frame: Up to 5 minutes

Data from ClinicalTrials.gov

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