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

Abbott

Status: Enrolling

Conditions: Hematologic Tests

Treatments: Diagnostic Test: Capillary blood draw

Study type: Interventional

Funder types: Industry

Identifiers

NCT07287631

CS-2025-0002

Details and patient eligibility

About

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

Full description

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.

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

Precision of potassium (K) and ionized calcium (iCa) tests in capillary blood

Other group

Description:

Precision evaluation of the i-STAT K test and the i-STAT iCa test using i-STAT CG8+ cartridge on i-STAT 1 analyzer with capillary specimens from each subject enrolled in the study.

Treatment:

Diagnostic Test: Capillary blood draw