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Method comparison study for Potassium (K) and ionized calcium (iCa).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Method comparison for K and iCa Tests using capillary whole blood specimens. | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fingerstick blood draw | Diagnostic Test | Capillary blood specimen collected from two separate fingersticks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance comparison | Compare the performance of the Potassium (K) test using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the K test on a comparator device. | Up to 5 minutes |
| Performance comparison | Compare the performance of the ionized calcium (iCa) test using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the iCa test on a comparator device. | Up to 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
• Prior enrollment in the study
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| Name | Affiliation | Role |
|---|---|---|
| Manish Gupta, BS, MBA | Abbott Point of Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland (UMD) | Baltimore | Maryland | 17033 | United States | ||
| Penn State University Hershey Medical Center (Hershey) |
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Capillary whole blood specimens will be tested in duplicate on the i-STAT 1 Analyzer with the CG8+ cartridge and a blood analyte testing comparator device.
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| Hershey |
| Pennsylvania |
| 17033 |
| United States |
| Eastside Research Associates (ERA) | Redmond | Washington | 98052 | United States |
| Abbott Point of Care (APOC) | Ottawa | Ontario | K2H 8V4 | Canada |