Further information regarding metrological traceability is available from Abbott Point of Care Inc.
Creatinine istat venous verification#
i-STAT System controls and calibration verification materials are validated for use only with the i-STAT System and assigned values may not be commutable with other methods. National Institute of Standards and Technology (NIST) standard reference material SRM909. Creatinine values assigned to i-STAT’s controls and calibration verification materials are traceable to the U.S. Metrological Traceability The i-STAT System test for creatinine measures creatinine amount-of-substance concentration in the plasma fraction of arterial, venous, or capillary whole blood (dimension µmol L-1) for in vitro diagnostic use. For cartridges that contain a sensor for the measurement of creatinine, a list of reactive ingredients is indicated below: Reactive IngredientĬreatinine Creatine Amidinohydrolase Creatinine Amidohydrolase Sarcosine Oxidase Contents Each i-STAT cartridge contains one reference electrode (when potentiometric sensors are included in the cartridge configuration), sensors for the measurement of specific analytes, and a buffered aqueous calibrant solution that contains known concentrations of analytes and preservatives. INTENDED USE The test for creatinine, as part of the i-STAT System, is intended for use in the in vitro quantification of creatinine in arterial, venous, or capillary whole blood. Certain substances, such as drugs, may affect analyte levels in vivo.1 If results appear inconsistent with the clinical assessment, the patient sample should be retested using another cartridge. See below for information on factors affecting results. The liberated hydrogen peroxide is oxidized at the platinum electrode to produce a current which is proportional to the sample creatinine concentration.
The oxidation of sarcosine, catalyzed by the enzyme sarcosine oxidase, produces hydrogen peroxide (H2O2). Creatine is then hydrolyzed to sarcosine in a reaction catalyzed by the enzyme creatine amidinohydrolase. Creatinine is hydrolyzed to creatine in a reaction catalyzed by the enzyme creatinine amidohydrolase. Initial Orientation & Training – This must be completed ( once) with all new staff trained to use this test.Ĭompetency Test Basic User – This must be completed by all testing personnel 1) After initial training and before technical duties are performed 2) 6 months after initial training (California Law) and 3) annually thereafter.Ĭompetency Test Super User – This must be completed by all testing personnel 1) After initial training and before technical duties are performed 2) 6 months after initial training (California Law) and 3) annually thereafter.Creatinine is measured amperometrically. INITIAL ORIENTATION, TRAINING & COMPETENCY IDA Pages (Clinical Indications, Documentation Plan, Clinical Actions) With the iSTAT 1 System, the FDA has categorized the Creatinine Cartridge as a Waived Complexity Test when testing is performed using venous whole blood samples collected in sodium or lithium heparin evacuated tubes only. The iSTAT 1 analyzer is intended for use in approved Point of Care locations. This procedure is to detect patients with renal failure who might be harmed by intravenous contrast media used for imaging procedures.
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