Completed

NCT Number: NCT06295835

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abbott Point of Care (APOC), Ottawa, Ontario, Canada

About this study

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.

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 (if required by the IRB)
≥ 18 years of age

Exclusion criteria

Prior enrollment in the study

Treatment and study plan

Fingerstick blood draw

Diagnostic Test

Capillary blood specimen collected from two separate fingersticks.

Primary outcomes

Performance comparison

Time frame: Up to 5 minutes

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.
Performance comparison

Time frame: Up to 5 minutes

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.

Sponsors and collaborators

Lead sponsor

Abbott Point of Care

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Mar 6, 2024
Registry last updated: Mar 19, 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.