#Istat test cartridges registration#
#Istat test cartridges portable#

(K), chloride (Cl), ionized calcium (iCa), glucose, urea nitrogen (UN), creatinine, hematocrit (hct), pH, partial pressure In this report we describe precision, linearity, and comparison studies of i-STAT measurements of blood sodium (Na), potassium One of our major concerns as health-care providers and clinical laboratorians is the validation of measurements by POC devicesĬompared to the primary instruments and methods used in the central clinical laboratory, to ensure the transferability andĬonsistent interpretation of test results. Previous evaluations of assays of whole blood electrolytes, metabolites, and blood gases with this analyzer in variousĬlinical settings have generally provided favorable, but occasionally somewhat unfavorable, critiques. Windsor, NJ), a POC device that uses various single-use multisensor cartridges, that was marketed in the United States early

#Istat test cartridges portable#

We evaluated the i-STAT Portable Clinical Analyzer (PCA i-STAT Corp, East Glucose, coagulation assays, and urine analysis. The need for more specialized and efficient support systems for neonatal and pediatric patients who require intensive careĪt our medical center mandated our clinical laboratory to expand point of care (POC) testing, in addition to that for blood Previous Section Next Section Introduction Of the PCA is attributed to careful analytical evaluations and ongoing communication with the clinical staff.

This problem notwithstanding, the successful implementation Samples) and to our eventual discontinuation of the PCA creatinine assay. Neonatal blood samples that would have affected clinical management led to a second creatinine comparison study (59 additional Reproducibility (CV) was good ( or < 3 mo) showed that agreement between the PCA and the primary methods was clinically acceptable.Īfter the PCA was implemented for clinical testing, the observation of discrepant results of creatinine concentrations in Supplemented with several analytes, and ~225 blood samples from patients. Four cartridge types: (a) EC8+ (sodium potassium chloride urea glucose pH blood gases ), (b) EC6+ (sodium potassium ionized calcium glucose hematocrit pH), (c) G3+ (pH pO 2 pCO 2), and (d) creatinine, were assessed for reproducibility, linearity, and method comparisons using aqueous samples, blood samples The clinical laboratory’s primary methods (Radiometer ABL 725 blood gas analyzer Vitros 750 chemistry analyzer and Coulter The neonatal and pediatric intensive care units of the MUSC Children’s Hospital would be as reliable as those performed by Our objective was to determine whether PCA measurements at the bedside of patients in Of a hand-held analyzer and single-use cartridges that measure different panels of electrolytes, metabolites, blood gases,Īnd hematocrit in 65–100 μl of blood. For i-STAT test cartridge information and intended use, refer to individual product pages or the cartridge information (CTI/IFU) in the i-STAT Support area.Ībbott - A Leader in Rapid Point-of-Care Diagnostics.We evaluated the analytical performance of the i-STAT Portable Clinical Analyzer (PCA), a point-of-care testing system consisting Check with your local representative for availability in specific markets. Not all products are available in all regions. GDPR Statement | Declaration for California Compliance Law. Any person depicted in such photographs is a model. Photos displayed are for illustrative purposes only. Your use of this website and the information contained herein is subject to our Website Terms and Conditions and Privacy Policy: US Citizens | Non-US Citizens.

#Istat test cartridges registration#

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