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

Clinical Evaluation of the Potassium (K) and Ionized Calcium (iCa) Tests in Capillary Specimens Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer

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

Study Overview

• Status: Completed
• Conditions: Potassium (K) & Ionized Calcium (iCa) in Capillary Whole Blood
• Intervention / Treatment: Diagnostic test: Fingerstick blood draw

Detailed Description

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
• Enrollment (Actual): 232
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K2H 8V4
      • Abbott Point of Care (APOC)
• United States
  • Maryland
    • Baltimore, Maryland, United States, 17033
      • University of Maryland (UMD)
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State University Hershey Medical Center (Hershey)
  • Washington
    • Redmond, Washington, United States, 98052
      • Eastside Research Associates (ERA)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Signed and dated consent form (if required by the IRB)
• ≥ 18 years of age

Exclusion Criteria:

• Prior enrollment in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Method comparison for K and iCa Tests using capillary whole blood specimens.; 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 collected from two separate fingersticks.	Diagnostic test: Fingerstick blood draw; Capillary blood specimen collected from two separate fingersticks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 5 minutes

Collaborators and Investigators

• Sponsor: Abbott Point of Care
• Investigators: Study Director: Manish Gupta, BS, MBA, Abbott Point of Care

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2024
• Primary Completion (Actual): January 29, 2025
• Study Completion (Actual): January 29, 2025

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CS-2024-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No