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Point of Care & Volume 10, Number 3, September 2011 Analytical Performance of ABL90 FLEX
with gas mixtures of known compositions (CO2/O2/N2 and CO/ bovine albumin solution. The maximum volume of the spiking
N2). For the electrolytes, the whole blood samples were spiked solution was 40% (vol/vol; typical volume, 5% [vol/vol]). For
with concentrated aqueous electrolyte solutions and bovine al- the parameter tHb, different levels were obtained by fractioning
bumin solution. The maximum volume of spiking solution in the the whole blood in erythrocytes and plasma and then mixing
test sample was 35% (vol/vol; typical volume, 15% [vol/vol]). these fractions to obtain the specific levels. For the parameter
For glucose and lactate, the whole blood samples were spiked MetHb, the whole blood was chemically treated with potassium
with concentrated aqueous glucose and lactate solutions and nitrite to obtain the specified level.
TABLE 2. Accuracy Data; Comparison of the ABL90 FLEX Analyzer With the ABL735, ABL835 FLEX, and ABL80 FLEX
CO-OX Analyzers
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Seeger et al Point of Care & Volume 10, Number 3, September 2011
FIGURE 1. Bland-Altman plot comparison of the ABL90 FLEX versus the ABL835 FLEX analyzers.
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Point of Care & Volume 10, Number 3, September 2011 Analytical Performance of ABL90 FLEX
FIGURE 1. (Continued).
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Seeger et al Point of Care & Volume 10, Number 3, September 2011
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* 2011 Lippincott Williams & Wilkins
Point of Care
TABLE 4. QUALICHECK5+ Measurements on the ABL90 FLEX Analyzer
&
Radiometer Radiometer
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Radiometer Radiometer
RiliBÄK Insert Control RiliBÄK Insert Control
Parameter Units Concentration Mean Bias Limits (+/j) Limits (+/j) Concentration Mean Bias Limits (+/j) Limits (+/j)
pH 7.572 j0.0039 0.0303 0.025 6.779 j0.0001 0.0271 0.02
PCO2 mm Hg 13.5 0.91 2 2 102 j1.358 6.63 8
PO2 mm Hg 47.1 1.065 5.181 10 296 j1.739 16.28 25
K+ mM 5.6 j0.127 0.252 0.3 6.3 j0.1254 0.284 0.3
Na+
glucose and lactate (0.14Y0.76 mM); tHb (0.14Y0.28 g/dL); and and 3.5 mM at 160 mM; and (3) a positive bias for glucose of
SO2, O2Hb, HHb, COHb, and MetHb (0.22%Y0.74%). These 2.5 mM at 25 mM.
findings are in agreement with the Sy.x obtained from previous
POC studies performed at hospital settings during the develop-
ment process of the ABL90 FLEX analyzer.4 Imprecision
In Figure 1, Bland-Altman plots of the different parameters For all parameters analyzed except PO2, the coefficient
obtained with the ABL90 FLEX analyzer and the comparison of variation (CV) and
qffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffi
ffi the total variations (ST)
method ABL835 FLEX analyzer are shown. Overall, these plots (S T ¼ S 2Wr þ S 2Br þ S 2Bd , where SWr = within-run variation,
show excellent agreement between the 2 methods for all param-
eters, with 3 observations on the Bland-Altman plots on the fol- SBr = between-run variation, and SBd = between-day variation)
lowing parameters: (1) a negative bias of 2.5 mm Hg of PCO2 at were in agreement with the performance characteristics of
80 mm Hg; (2) a positive bias for Na+ of 1.3 mM at 140 mM the ABL90 FLEX4 (Table 3). For PO2, minor deviations were
FIGURE 2. Bland-Altman plots; NIST for glucose and electrolytes measurements on the ABL90 FLEX analyzer.
Copyright © 2011 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Point of Care & Volume 10, Number 3, September 2011 Analytical Performance of ABL90 FLEX
observed at PO2 levels 40 and 160 mm Hg. For all other levels of observed for glucose fulfills the minimum accuracy requirements
PO2, no deviations were observed. of the DIN EN ISO 15197:2010 standard7 because more than
The QUALICHECK5+ measurement data on the ABL90 95% of the results are within T0.83 mM of the reference method
FLEX analyzer, the RiliBÄK,5 and the Radiometer insert control at glucose concentrations less than 5.55 mM and within T15%
limits are shown in Table 4. The mean biases for all levels of the at glucose concentrations greater than 5.55 mM.
QUALICHECK5+ measurements are within both the RiliBÄK The imprecision data of the ABL90 FLEX analyzer were
limits and the Radiometer insert control limits for parameters satisfactory for all parameters with CVs equal to those stated in
tested. The quality control data obtained on the other ABL ana- the ABL90 FLEX reference manual4 except for a slightly ele-
lyzers included in this study were generally within the RiliBÄK vated ST in PO2. The deviations were observed at levels of 40
limits and in all cases within the Radiometer insert control limits and 160 mm Hg and were caused by 1 single slightly deviating
(data not shown). result for each level. The deviations are very moderate and have
no clinical impact.
Certified Serum Reference Material The ABL90 FLEX analyzer also fulfilled the German
The certified reference material from NIST for glucose and RiliBÄK5 requirements for quality assurance for medical quan-
electrolytes on the ABL90 FLEX analyzer showed regression titative determinations as well as the Radiometer insert control
lines as follows: for glucose, y = 1.0190xNIST + 0.02326 over requirements for all analyzed parameters.
the tested range of 2 to 16 mM; for Ca2+, y = 1.0338xNIST j In a recent study by Cembrowski et al,8 the biological vari-
0.07291 over the tested range of 1.1 to 1.7 mM; for Clj, y = ation for blood gas, electrolytes, and glucose testing of medical
1.1144xNIST j 9.9469 over the tested range of 98 to 128 mM; and surgical patients in an intensive care unit (ICU) was esti-
for K+, y = 0.9681xNIST + 0.0091 over the tested range of 2 to mated. The study was based on 28,000 blood gas measurements
6 mM; and for Na+, y = 1.0046xNIST j 1.5964 over the tested on an ABL800 analyzer obtained from 1676 ICU patients during
range of 120 to 160 mM, showing that the NIST measurements 11 months. The conclusion of the study was, ‘‘derivation of the
on the ABL90 FLEX analyzer are in agreement with the NIST ratio of biologic to analytic variation indicates that the ABL800
SRM965a for glucose and the NIST SRM956b for electrolytes. is extremely suitable for ICU testing.’’ In our study, we dem-
In Figure 2, Bland-Altman plots of the NIST measurements are onstrated that the ABL90 FLEX analyzer has an analytical
shown for the 5 parameters tested. The plots show an excellent performance equal to the ABL835 FLEX analyzer and hence an
agreement between the NIST standards and the result from the appropriate choice for testing in the ICU/POC environment.
ABL90 FLEX analyzer. The NIST standards for glucose and In conclusion, we have demonstrated that the ABL90 FLEX
electrolytes for the other ABL analyzers used in this study were blood gas analyzer shows an excellent analytical performance
all in agreement with NIST SRM965a and SRM956b (data not and correlates favorably with the ABL835 FLEX analyzer. It
shown). also fulfills the German RiliBÄK requirements for all param-
eters tested. Furthermore, it has many features suitable for
DISCUSSION POC use, which comply with the demands of nonYlaboratory
Comparison of the ABL90 FLEX blood gas analyzer with personnel.
the ABL835 FLEX, ABL735, and the ABL80 FLEX CO-OX
analyzer showed that the ABL90 FLEX analyzer fulfills the REFERENCES
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Copyright © 2011 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.