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Assessing precision of i-STAT K test using the IUO 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 test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer with investigational software using results from two (2) different fingerstick specimens from the same subject across the K measurement range.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precision assessment of Potassium (K) test in capillary blood sample | Other | Prospectively collected capillary specimens from two separate fingerstick blood draws. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fingerstick blood draw | Diagnostic Test | Capillary blood specimen collected from two separate fingerstick blood draws. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Precision for Potassium (K) Test | Clinical Evaluation of Precision for the Potassium (K) Test in Capillary Specimens using the i-STAT CG8+ Cartridge with the i-STAT 1 Analyzer | 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, Baltimore (UMD) | Baltimore | Maryland | 21201 | United States | ||
| Penn State Health Milton S. Hershey Medical Center (Hershey) |
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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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Capillary precision analysis will be performed for Potassium K.
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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 |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |