Lab Med Online.  2017 Jan;7(1):20-27. 10.3343/lmo.2017.7.1.20.

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

• Yi A
• Kim H
• Moon HW
• Hur M
• Yun YM

• KMID: 2363002
• DOI: http://doi.org/10.3343/lmo.2017.7.1.20

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.

Keyword

i-Smart; Blood gas analyzer; Point-of-care systems; Performance

MeSH Terms

Blood Gas Analysis
Calcium
Carbon Dioxide
Critical Care
Hematocrit
Hydrogen-Ion Concentration
Oxygen
Partial Pressure
Point-of-Care Systems
Potassium
Sodium
Calcium
Carbon Dioxide
Oxygen
Potassium
Sodium

Figure

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  Fig. 1. Comparison of pH, pCO2, pO2, Na+, K+, Cl-, Ca2+, and Hematocrit results tested by the i-Smart 300 and STP CCX for 40 samples. (A, C, E, G, I, K, M, O) Correlation between the i-Smart 300 and Nova CCX. Solid line, Passing-Bablok regression; dashed line, identity line. (B, D, F, H, J, L, N, P) Difference between the i-Smart 300 and Nova CCX. Bold line, mean difference between values; dotted lines, desirable specification for allowable total error.

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  Fig. 1. Continued.

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  Fig. 1. Continued.

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