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Clinical Precision and In-use Analyte Stability Study for 19 Parameters in Adult Arterial Whole Blood for PICO70 and SafePICO
The purpose is to characterize the precision and in use stability of 19 parameters (pH, pCO2, pO2, cNa+, cCa2+, cCl-, cK+, cGlu, cLac, cUrea/BUN, cCrea, ctHb, sO2, FMetHb, FCOHb, FO2Hb, FHHb, FHbF \& ctBil) in arterial blood drawn and stored in self-filling syringes (PICO70 and safePICO) across different lots of samplers measured on ABL90 FLEX PLUS analyzer. The study aims to determine the total (within Lot and Lot-to-Lot) precision for the PICO70/safePICO in arterial whole blood. Furthermore, the study aims to determine the stability for up to 45 min. at room temperature (18-25 °C) for arterial blood sample analysis in the PICO70/safePICO for all 19 parameters.
Details
| Lead sponsor | Radiometer Medical ApS |
|---|---|
| Status | COMPLETED |
| Enrolment | 63 |
| Start date | Tue Jun 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Oct 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Precision and Stability in Adult Arterial Whole Blood Contained in PICO70 and SafePICO for Each Parameter
Interventions
- Arterial blood samplers with needles PICO70 and safePICO syringes
Countries
Denmark