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Assess precision of the i-STAT potassium (K) and ionized calcium (iCa) tests using i-STAT CG8+ cartridge on the i-STAT 1 analyzer.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precision of potassium (K) and ionized calcium (iCa) tests in capillary blood | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capillary blood draw | Diagnostic Test | Capillary whole blood specimens collected from fingerstick(s) will be collected from each enrolled subject with blood collection capillary tubes. |
| Measure | Description | Time Frame |
|---|---|---|
| Precision assessment | Assess the precision of the i-STAT potassium (K) and ionized calcium (iCa) tests in mmol/L with the investigational use only (IUO) i-STAT CG8+ cartridge on the i-STAT 1 analyzer using results from capillary specimens from each subject enrolled in the study. | Thirty (30) minutes from subject enrollment to the end of the blood draw and testing. |
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Inclusion Criteria:
Exclusion Criteria:
1. Previous enrollment in this study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miranda Gonzalez Aguirre, PhD | Contact | 613-604-8539 | miranda.gonzalezaguirre@abbott.com |
| Name | Affiliation | Role |
|---|---|---|
| Manish Gupta, MS, MBA | Abbott Point of Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Recruiting | Albuquerque | New Mexico | 87131 | United States |
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| Penn State Health Milton S. Hershey Medical Center (Hershey) | Not yet recruiting | Hershey | Pennsylvania | 17033 | United States |
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| Medical College of Wisconsin | Not yet recruiting | Milwaukee | Wisconsin | 53226 | United States |
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