Evaluation of Potassium (K) and Ionized Calcium (iCa) Tests Using Capillary Specimens

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
Abbott Point of Care
Study ID
NCT07287618
Status
Recruiting

Conditions

  • Hematologic Tests

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Blood draw — DIAGNOSTIC_TEST
    Capillary whole blood specimens collected from fingerstick(s) from each enrolled subject using blood collection capillary tubes.

Study Details

The objective of this study is to compare the performance of blood tests using the i-STAT 1 System against a comparator blood analysis system.

Key Dates

Start date
Sep 17, 2025
Status verified
Dec 2025
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
425 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: Method comparison for K and iCa tests using capillary whole blood specimens.
    Performance comparison: Using results from capillary whole blood specimens collected from fingerstick(s) from each subject enrolled in the study, the performance between i-STAT potassium (K) and ionized calcium (iCa) tests using i-STAT CG8+ cartridge on i-STAT 1 analyzer and a comparator blood analysis system will be compared.

Primary Outcome Measure

Method Comparison for potassium (K) and ionized calcium (iCa) blood tests. [ Time Frame: Thirty (30) minutes from subject enrollment to the end of the blood draw and testing. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of New MexicoAlbuquerqueNew Mexico87131
Justin T Baca, MD, PhD
Penn State Health Milton S. Hershey Medical Center (Hershey)HersheyPennsylvania17033
Michael H Creer, MD
Medical College of WisconsinMilwaukeeWisconsin53226
Tom Aufderheide, MD
414-955-1174

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