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Yi, Kim, Moon, Hur, and Yun: Performance Evaluation of Cartridge-Type Blood Gas Analyzer: i-Smart 300
Original Article

Lab Med Online 2017;7(1):20-27.

Published online: 17 January 2017

DOI: https://doi.org/10.3343/lmo.2017.7.1.20

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

Ahram Yi, M.D., Hanah Kim, M.D., Hee-Won Moon, M.D., Mina Hur, M.D., Yeo-Min Yun, M.D.

Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea

Corresponding author: Yeo-Min Yun Department of Laboratory Medicine, Konkuk University School of Medicine Konkuk University Hospital, 120-1 Neungdong-ro, Gwangjin-gu, Seoul 05030, Korea Tel: +82-2-2030-5582, Fax: +82-2-2030-5587, E-mail: ymyun@kuh.ac.kr

Received 23 December 201526 April 2016       Accepted 3 May 2016

Copyright © 2017 The Korean Society for Laboratory Medicine

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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 benchtop blood gas analyzer. It could be useful in critical care settings.

Keywords: i-Smart, Blood gas analyzer, Point-of-care systems, Performance

REFERENCES

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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.
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Fig. 1.
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Table 1.
Evaluation of total precision for blood gas and electrolytes using three levels of control materials on the i-Smart 300 blood gas analyzer, with allowable precision, difference, and total error
Parameter Level Mean Between-run Between-day Within-run Total-run CVw∗ Desirable precision criteria (%)∗
SD CV (%) SD CV (%) SD CV (%) SD CV (%)
pH Low 7.1604 0.0020 0.03 0.0033 0.05 0.0027 0.04 0.0047 0.07 0.2 0.1
  Medium 7.4094 0.0036 0.005 0.0000 0.00 0.0014 0.02 0.0039 0.05    
  High 7.6433 0.0040 0.05 0.0042 0.05 0.0020 0.03 0.0061 0.08    
pCO2 (mmHg) Low 18.77 0.23 1.24 0.05 0.25 0.12 0.61 0.26 1.40 4.0 2.0
  Medium 39.23 0.45 1.14 0.00 0.00 0.16 0.40 0.47 1.20    
  High 66.21 0.50 0.76 0.24 0.36 0.45 0.67 0.71 1.08    
pO2 (mmHg) Low 70.6 1.49 2.11 0.80 1.13 1.77 2.50 2.45 3.46 N/A N/A
  Medium 90.5 2.13 2.24 0.70 0.73 1.02 1.08 2.46 2.60    
  High 126.5 2.40 1.90 0.00 0.00 1.20 0.95 2.68 2.12    
Na+ (mmol/L) Low 113.7 0.00 0.00 0.36 0.32 0.46 0.41 0.59 0.52 0.6 0.3
  Medium 132.4 0.40 0.30 0.00 0.00 0.46 0.35 0.61 0.46    
  High 154.8 0.37 0.24 0.41 0.26 0.46 0.30 0.72 0.46    
K+ (mmol/L) Low 2.02 0.02 0.78 0.03 1.61 0.02 1.11 0.04 2.10 4.6 2.3
  Medium 4.28 0.02 0.37 0.04 0.83 0.02 0.45 0.04 1.02    
  High 5.98 0.02 0.26 0.05 0.78 0.04 0.67 0.06 1.07    
Cl- (mmol/L) Low 74.9 0.32 0.42 0.14 0.19 0.35 0.47 0.50 0.66 1.2 0.6
  Medium 94.4 0.37 0.39 0.14 0.15 0.46 0.49 0.61 0.64    
  High 126.0 0.58 0.46 0.58 0.46 0.40 0.32 0.92 0.73    
Ca2+ (mmol/L) Low 0.577 0.004 0.07 0.007 1.26 0.004 0.73 0.009 1.61 1.7 0.9
  Medium 1.163 0.009 0.79 0.004 0.35 0.006 0.48 0.011 0.99    
  High 1.474 0.006 0.39 0.014 0.97 0.008 0.53 0.017 1.17    
Hematocrit (%) Low 27.0 0.32 1.17 0.23 0.87 0.30 1.10 0.49 1.83 2.7 1.35
  High 51.6 0.39 0.75 0.23 0.44 0.37 0.72 0.58 1.13    

It uses a design with 20 testing days, two runs per testing day, and two replicate measurements per run (n=20×2×2=80) for each sample using a single reagent and single calibrator lot, according to the CLSI EP5-A3. Three levels of aqueous quality control (QC) material were used, RNA QC 623 Blood Gas-Electrolyte Control (RNA Medical, Devens, MA, USA), and two levels of RNA QC 900 Hematocrit Control (RNA Medical, Devens, MA, USA) were used.

∗ Within-subject variation and desirable analytical precision criteria are referenced from Ricos et al. [10], and the biological variation database specification on Westgard's website (https://www.westgard.com/biodatabase1.htm) [11].

Abbreviations: CV, coefficient variation; CVw, within-subject biological variation; NA, not available.

Table 2.
Evaluation of linearity from eight parameters using five levels of control materials with the i-Smart 300 blood gas analyzer
Parameter (unit) Test range Observed linear range Manufacturer claimed AMR Correlation (r) Regression % Recovery P value
i-Smart 300 Nova CCX
pH (pH unit) 6.867-7.802 6.867-7.802 6.500-8.000 6.500-8.000 0.9994 y=0.9992x+0.0175 100.0–100.4 <0.0001
pCO2 (mmHg) 12.7-83.7 12.7-83.7 5.0-150.0 3.0-200 0.9994 y=0.9726x+0.3973 96.1–99.8 <0.0001
pO2 (mmHg) 41.0-462.5 69.0-462.5 5-700 0-800 0.9998 y=0.9959x+2.8820 98.6–120.6∗ <0.0001
Na+ (mmol/L) 86.0-160.5 86.0-160.5 80-200 80-200 0.9998 y=0.9879x+0.1835 98.5–99.4 <0.0001
K+ (mmol/L) 1.60-11.30 1.60-11.30 1.0-20.0 1.0-20.0 0.9998 y=1.0150x-0.1078 95.0–100.9 <0.0001
Cl- (mmol/L) 67.5-130.0 67.5-130.0 50-150 50-200 0.9998 y=1.0200x-1.0100 94.3–101.9 <0.0001
Ca2+ (mmol/L) 0.265-3.345 0.265-3.345 0.25-5.00 0.1-2.7 0.9998 y=1.0190x-0.0292 100.0–101.6 <0.0001
Hematocrit (%) 21.5-69.0 21.5-69.0 10-70 12-70 0.9998 y=0.9934x+0.3701 100.0–102.4 <0.0001

∗ The % recovery of pO2 ranged from 98.6% to 120.6%. Except for the coded concentration 34, the % recovery of pO2 ranged from 98.6% to 101.5%. Abbreviation: AMR, analytical measurement range.

Table 3.
Comparison of results obtained using the i-Smart 300 and Nova CCX (n=40)
Parameter Test range Correlation (r) (95% CI) Slope∗ (95% CI) Intercept∗ (95% CI) Mean difference† (95% CI)
pH (pH unit) 7.067-7.540 0.982 (0.967-0.991) 1.33 (1.25 to 1.40) -2.36 (-2.94 to -1.79) 0.0424 (0.0330 to 0.0518)
pCO2 (mmHg) 19.9-77.9 0.979 (0.958-0.988) 0.95 (0.85 to 1.05) -3.38 (-7.44 to 0.68) -5.41 (-6.053 to -4.762)
pO2 (mmHg) 37.2-225.8 0.993 (0.987-0.996) 1.08 (1.03 to 1.12) -3.00 (-8.97 to 2.97) 5.73 (3.10 to 8.36)
Na+ (mmol/L) 124.5-144.8 0.966 (0.936-0.982) 1.02 (0.93 to 1.10) -3.09 (-14.24 to 8.06) -1.01 (-1.36 to 0.66)
K+ (mmol/L) 2.67-6.59 0.996 (0.993-0.998) 0.88 (0.86 to 0.91) 0.34 (0.23 to 0.45) -0.128 (-0.161 to -0.095)
Cl- (mmol/L) 88.8-116.7 0.970 (0.943-0.984) 1.05 (0.95 to 1.14) -4.17 (-14.22 to 5.88) 0.86 (0.49 to 1.23)
Ca2+ (mmol/L) 0.78-1.51 0.975 (0.952-0.987) 1.05 (0.95 to 1.15) -0.15 (-0.27 to -0.03) -0.091 (-0.100 to -0.082)
Hematocrit (%) 24-53 0.974 (0.951-0.986) 1.07 (0.99 to 1.15) -5.08 (-8.08 to -2.08) -2.6 (-3.0 to -2.1)

∗ Determined using Deming fit;

† Mean difference is defined as measured values of the i-Smart 300 minus Nova CCX. Abbreviation: CI, confidence interval.

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