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

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.

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Key information

Conditions

Hematologic Tests

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico, Albuquerque, New Mexico, United States

About this study

To compare the performance of the i-STAT potassium (K) and ionized calcium (iCa) tests using the i-STAT CG8+ cartridge on the i-STAT 1 analyzer to the performance of K and iCa tests on a comparator blood analysis system using results from two separate capillary specimens from each subject enrolled in the study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Signed and dated consent form (waiver/alteration of consent, waiver of documentation of consent may be acceptable, per IRB)
≥ 18 years of age

Exclusion criteria

Previous enrollment in this study

Treatment and study plan

Blood draw

Diagnostic Test

Capillary whole blood specimens collected from fingerstick(s) from each enrolled subject using blood collection capillary tubes.

Primary outcomes

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.

Specimen testing of K and iCa in mmol/L will be performed using the i-STAT CG8+ cartridge on the i-STAT analyzer and a comparator blood analysis system with prospectively collected capillary specimens.

Subjects with one valid capillary result on the i-STAT CG8+ cartridge and one valid result on the comparator blood analysis system will be evaluated.

Study contacts

Contact information is provided by the study sponsor or research team.

Miranda Gonzalez Aguirre, PhD

CONTACT

[email protected]

613-604-8539

Sponsors and collaborators

Lead sponsor

Abbott Point of Care

Industry

Registry information

Official study title

Clinical Evaluation of Potassium and Ionized Calcium Tests Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer for Capillary Specimens

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Dec 17, 2025
Registry last updated: Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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