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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
425
Capillary whole blood specimens collected from fingerstick(s) from each enrolled subject using blood collection capillary tubes.
University of New Mexico
Albuquerque, New Mexico, United States
RECRUITINGPenn State Health Milton S. Hershey Medical Center (Hershey)
Hershey, Pennsylvania, United States
NOT_YET_RECRUITINGMedical College of Wisconsin
Milwaukee, Wisconsin, United States
NOT_YET_RECRUITINGMethod Comparison for potassium (K) and ionized calcium (iCa) blood tests.
Specimen testing of K and iCa in mmol/L will be performed using the i-STAT CG8+ cartridge on the i-STAT analyzer and a comparator blood analysis system with prospectively collected capillary specimens. Subjects with one valid capillary result on the i-STAT CG8+ cartridge and one valid result on the comparator blood analysis system will be evaluated.
Time frame: Thirty (30) minutes from subject enrollment to the end of the blood draw and testing.
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