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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Method comparison for K and iCa tests using capillary whole blood specimens. | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draw | Diagnostic Test | Capillary whole blood specimens collected from fingerstick(s) from each enrolled subject using blood collection capillary tubes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Method 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. | 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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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Method Comparison Study
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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 |
|
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |