Performance Evaluation of Cartridge-Type Blood Gas Analyzer: i-Smart 300

Abstract

dioxide pressure (pCO2), and partial oxygen pressure (pO2). Moreover, the simultaneous measurement of electrolytes such as sodium (Na ), and ionized calcium (Ca 2+ ) is available with hematocrit (Hct). Integration and immediate therapeutic response using these results allows for prompt treatment and improvement of prognosis. Therefore, blood gas analyzers are being demanded for both their rapid turn-around of test results and sophisticated result accuracy. While most of the blood gas analyzers are used on-site, such as in emergency departments and ICUs for point of care (POC) testing, even benchtop models are currently in use at most clinical laboratories.In the use of POC analyzers, quality control is a big issue. The users of POC analyzers are often unfamiliar with laboratory instruments and unacquainted with the maintenance and quality control of the instrument. Therefore, cartridge-type instruments are welcomed for most POC instruments, not only blood gas analyzers, but also molecular diagnostic analyzers [3]. If, however, Background: Blood gas analysis plays a crucial role in critical care settings, and immediate and precise analysis improves clinical outcomes through prompt treatment. We evaluated the performance of a cartridge-type blood gas analyzer, i-Smart 300 (i-SENS, Korea), according to the Clinical and Laboratory Standard Institute (CLSI) guidelines and compared it to a conventional blood gas analyzer. Methods: The precision was evaluated according to CLSI EP5-A3. The i-Smart 300 was compared to the Stat Profile Critical Care Xpress (STP CCX) (Nova CCX; Nova Biomedical, USA) according to CLSI EP9-A3 using the following eight parameters: pH, partial carbon dioxide pressure, partial oxygen pressure, sodium, potassium, chloride, ionized calcium, and hematocrit. Linearity was determined using five levels of control materials according to CLSI EP6-A. Results: Within-run precision and total precision, demonstrated as coefficients of variation, ranged from 0.02 to 2.50% and from 0.05 to 3.46%, respectively. Correlation analysis yielded a correlation coefficient from 0.966 to 0.996 between the i-Smart 300 and the conventional analyzer (Nova CCX). The i-Smart 300 showed excellent linearity at eight parameters with acceptable percent recovery. Conclusions: The i-Smart 300, a portable cartridge-type blood gas analyzer, showed high precision and good correlation with a traditional benchtop blood gas analyzer. It could be useful in critical care settings.Key Words: i-Smart, Blood gas analyzer, Point-of-care systems, Performance