Method Comparison Study for Measuring Potassium (K) and Ionized Calcium (iCa) in Blood

Abbott Point of Care232 enrolled

Overview

Method comparison study for Potassium (K) and ionized calcium (iCa).

The objective of this study is to compare the performance of the K and iCa Tests using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the K and iCa Tests on the comparator device using capillary whole blood specimens. This objective will be assessed as part of a Method Comparison evaluation.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

232

Conditions

Potassium (K) & Ionized Calcium (iCa) in Capillary Whole Blood

Interventions

Fingerstick blood drawDIAGNOSTIC_TEST

Capillary blood specimen collected from two separate fingersticks.

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 (UMD)

Baltimore, Maryland, United States

Penn State University 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

Performance comparison

Compare the performance of the Potassium (K) test using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the K test on a comparator device.

Time frame: Up to 5 minutes

Performance comparison

Compare the performance of the ionized calcium (iCa) test using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the iCa test on a comparator device.

Time frame: Up to 5 minutes

Data from ClinicalTrials.gov

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