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Precision Study Measuring Potassium (K) in Capillary Specimens

Not Applicable
Completed
Conditions
Precision of Potassium (K) Test in Capillary Whole Blood
Interventions
Diagnostic Test: Fingerstick blood draw
Registration Number
NCT06291493
Lead Sponsor
Abbott Point of Care
Brief Summary

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

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
161
Inclusion Criteria
  • Signed and dated consent form (if required by the IRB)
  • ≥ 18 years of age
Exclusion Criteria

• Prior enrollment in the study

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Precision assessment of Potassium (K) test in capillary blood sampleFingerstick blood drawProspectively collected capillary specimens from two separate fingerstick blood draws.
Primary Outcome Measures
NameTimeMethod
Precision for Potassium (K) TestUp to 5 minutes

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (4)

University of Maryland, Baltimore (UMD)

🇺🇸

Baltimore, Maryland, United States

Eastside Research Associates (ERA)

🇺🇸

Redmond, Washington, United States

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

🇺🇸

Hershey, Pennsylvania, United States

Abbott Point of Care (APOC)

🇨🇦

Ottawa, Ontario, Canada

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