Performance Evaluation of Cartridge-Type Blood Gas Analyzer: i-Smart 300
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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 bench-top blood gas analyzer. It could be useful in critical care settings.
Abstract
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 bench-top blood gas analyzer. It could be useful in critical care settings.
참고문헌 (17)
- Uyanik M, "Comparison of blood gas, electrolyte and metabolite results measured with two different blood gas analyzers and a core laboratory analyzer", Scand J Clin Lab Invest, 75, pp.97~105 (2015)
- De Koninck AS, "Analytical performance evaluation of four cartridge-type blood gas analyzers", Clin Chem Lab Med, 50, pp.1083~1091 (2012)
- Einstein MH, "Clinical evaluation of the cartridge-based GeneXpert human papillomavirus assay in women referred for colposcopy", J Clin Microbiol, 52, pp.2089~2095 (2014)
- Leino A, "Interchangeability of blood gas, electrolyte and metabolite results measured with point-of-care, blood gas and core laboratory analyzers", Clin Chem Lab Med, 49, pp.1187~1191 (2011)
- CLSI, "Blood Gas and pH Analysis and Related Measurements; Approved Guideline", Clinical and Laboratory Standards Institute, ~ (2009)
- CLSI, "Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline", Clinical and Laboratory Standards Institute, ~ (2014)
- CLSI, "Preliminary evaluation of quantitative clinical laboratory measurement procedures; Approved Guideline", Clinical and Laboratory Standards Institute, ~ (2006)
- CLSI, "Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline", Clinical and Laboratory Standards Institute, ~ (2003)
- CLSI, "Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline" (2013), Clinical and Laboratory Standards Institute
- Ricós C, "Current databases on biological variation: pros, cons and progress", Scand J Clin Lab Invest, 59, pp.491~500 (1999)
- "Desirable specification for total error, imprecision, and bias, derived from intra-and inter-individual biologic variation" (2014)[URL]
- Nichols JH, "Executive summary. The National Academy of Clinical Biochemistry Laboratory Medicine Practice Guideline: evidence-based practice for point-of-care testing", Clin Chim Acta, 379, pp.14~28 (2007)
- Fraser CG, "Generation and application of data on biological variation in clinical chemistry", Crit Rev Clin Lab Sci, 27, pp.409~437 (1989)
- Cotlove E, "Biological and analytic components of variation in long-term studies of serum constituents in normal subjects. 3. Physiological and medical implications", Clin Chem, 16, pp.1028~1032 (1970)
- Harris EK, "Statistical principles underlying analytic goal-setting in clinical chemistry", Am J Clin Pathol, 72(2 Suppl), pp.374~382 (1979)
- Fraser CG., "General strategies to set quality specifications for reliability performance characteristics", Scand J Clin Lab Invest, 59, pp.487~490 (1999)
- Seok YM, "Evaluation of the i-Smart 30 Point-of-care analyzer for use in clinical laboratory settings", J Lab Med Qual Assur, 33, pp.25~30 (2011)