Clinical Evaluation of Precision for the Potassium and Ionized Calcium Tests in Capillary Specimens

Assess precision of the i-STAT potassium (K) and ionized calcium (iCa) tests using i-STAT CG8+ cartridge on the i-STAT 1 analyzer.

Recruiting

Interested in participating?

Request Info

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

The objective of this study is to assess the precision of the i-STAT K and iCa tests using the IUO i-STAT CG8+ cartridge on the i-STAT 1 analyzer 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

Capillary blood draw

Diagnostic Test

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

Primary outcomes

Precision assessment

Time frame: Thirty (30) minutes from subject enrollment to the end of the blood draw and testing.

Assess the precision of the i-STAT potassium (K) and ionized calcium (iCa) tests in mmol/L with the investigational use only (IUO) i-STAT CG8+ cartridge on the i-STAT 1 analyzer using results from capillary specimens from each subject enrolled in the study.

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 Precision for the 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.

Published trials that share one or more normalized conditions with this study.

Recruiting