A-349 Evaluation of i-STAT® Point of Care Blood Gas Cartridges and Competitor Blood Gas Devices Against Reference Standard for PCO2 and PO2

Abstract Background The i-STAT System provides laboratory quality results in minutes at the patient’s bedside. Accurate and rapid test results are critical for clinical decision making in the presence of blood gas disorders, including oxygenation and acid-base status, where the partial pressure oxygen (PO2) and partial pressure carbon dioxide (PCO2) are needed. The purpose of this study was to compare the analytical performance of the PO2 and PCO2 tests in the i-STAT G3+ and i-STAT CG8+ cartridges to the theoretical PO2 and PCO2 in prepared reference standards. Two other blood gas instruments, a benchtop device and a laboratory device were also compared to the reference PO2 and PCO2. Methods Venous whole blood samples were contrived using saturation tonometry with U.S. NIST (National Institute of Science and Technology) traceable gas tanks to prepare the reference standards, which were value assigned to theoretical PO2 or PCO2 levels based on the molar composition of the gas mixture used. Eleven levels spanning the reportable range of each PO2 (5 mmHg - 800 mmHg) and PCO2 (5 mmHg - 130 mmHg) were prepared and tested in duplicate on the i-STAT G3+ and i-STAT CG8+ cartridges, benchtop device, and the laboratory device. Passing-Bablok linear regression analysis was performed to evaluate the slope and correlation coefficient, comparing each blood gas device against the reference PO2 and PCO2 values. Study designs followed CLSI (Clinical and Laboratory Standards Institute) EP09C-ED3:2018, Measurement Procedure Comparison and Bias Estimation using Patient Samples, 3rd Edition. Passing-Bablok regression analysis was also performed for the i-STAT cartridges and benchtop device against the laboratory device. Results The regression analysis was performed against the reference standards. For PO2, slopes for the i-STAT cartridges ranged from 0.93 - 0.97, the slope for the benchtop device was 0.99, and the slope for the laboratory device was 0.97. Correlation coefficients for all devices were 1.00. For PCO2, slopes for the i-STAT cartridges ranged from 0.98 - 1.02, the slope for the benchtop device was 0.85, and the slope for the laboratory device was 1.01. Correlation coefficients were 1.00 for the i-STAT cartridges and laboratory device, and 0.99 for the benchtop device. The regression analysis was also performed against the laboratory device. For PO2, slopes for the i-STAT cartridges ranged from 0.96 - 1.00, and the slope for the benchtop device was 1.02. Correlation coefficients for all devices were 1.00. For PCO2, slopes for the i-STAT cartridges ranged from 0.97 - 1.01, and the slope for the benchtop device was 0.85. Correlation coefficients were 1.00 for the i-STAT cartridges and 0.99 for the benchtop device. Conclusions The study demonstrated that the i-STAT G3+ and i-STAT CG8+ cartridges used with the i-STAT System were shown to provide laboratory quality results within 2 minutes, showing good agreement to both reference standards and laboratory quality devices. For PCO2, the i-STAT System was shown to have better agreement to both theoretical reference standards and the laboratory device than the benchtop device. These studies were funded by Abbott Laboratories.