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

Abbott

Status: Completed

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

Treatments: Diagnostic Test: Fingerstick blood draw

Study type: Interventional

Funder types: Industry

Identifiers

NCT06295835

CS-2024-0001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 232 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Signed and dated consent form (if required by the IRB)
• ≥ 18 years of age

Exclusion criteria

• Prior enrollment in the study

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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232 participants in 1 patient group

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

Other group

Description:

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 collected from two separate fingersticks.

Treatment:

Diagnostic Test: Fingerstick blood draw