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

Abbott

Status: Enrolling

Conditions: Hematologic Tests

Treatments: Diagnostic Test: Blood draw

Study type: Interventional

Funder types: Industry

Identifiers

NCT07287618

CS-2025-0001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 425 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Signed and dated consent form (waiver/alteration of consent, waiver of documentation of consent may be acceptable, per IRB)
2. ≥ 18 years of age

Exclusion criteria

1. Previous enrollment in this study

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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425 participants in 1 patient group

Method comparison for K and iCa tests using capillary whole blood specimens.

Other group

Description:

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.

Treatment:

Diagnostic Test: Blood draw