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ORIGINAL ARTICLE

Analytical Performance of the ABL90 FLEX Blood Gas Analyzer


Corina Seeger, MSc, Ronald W. Kawiecki, PhD, and Hans Bjarne Kristensen, MSc

ABL90 FLEX analyzer offers simple operation procedures with


Abstract: We evaluated a new blood gas electrolyte analyzer (ABL90 automatic sampler detection and aspiration, integrated automatic
FLEX analyzer; Radiometer Medical) that has many feature suitable calibrations and quality controls, disposable reagent cartridges;
for point-of-care use, including a small sample volume of whole blood is a part of an automatic sample flow concept2; and is fully
(65 KL), a reduced measuring time (35 seconds) for a full-parameter compatible with the hospital information technology systems. In
profile, and similar analytical performance to standard blood gas ana- this study, the analytical performance of the ABL90 FLEX an-
lyzers. In this study, the analytical performance of the ABL90 FLEX blood alyzer is compared with the ABL835 FLEX, ABL735, and the
gas analyzer was evaluated against 3 other Radiometer standard blood gas ABL80 FLEX CO-OX analyzers on analyses of the following
analyzers (ABL835 FLEX, ABL735, and ABL80 FLEX CO-OX) by parameters: pH, PO2, PCO2, Na+, K+, Ca2+, Clj, glucose, lactate,
analyzing modified blood samples for the following parameters: pH, PO2, tHb, SO2, O2Hb, HHb, COHb, and MetHb.
PCO2, Na+, K+, Ca2+, Clj, glucose, lactate, tHb, SO2, O2Hb, HHb, COHb,
and MetHb. Commercial quality control material (QUALICHECK5+)
was used to evaluate between-day precision and certified reference mate-
MATERIALS AND METHODS
rials (NIST SRM956b for electrolytes and SRM965a for glucose) were
included in the study. We conclude that the ABL90 FLEX analyzer cor-
Heparinized whole blood from healthy adult individuals
related favorably with the 3 analyzers for all parameters tested and has
(modified to reach the desired concentration levels in each pa-
many features suitable for near-patient testing.
rameter case [low, normal, high]) was used.
For the parameters pH, PCO2, PO2, SO2, and COHb, each
Key Words: ABL90 FLEX analyzer, blood gas, analytical performance, specific level was obtained by equilibration of the whole blood
TAT, sandwich sensor
(Point of Care 2011;10: 108Y115)
TABLE 1. Measured and Calculated Parameters of the
ABL90 FLEX Analyzer

M easurements of blood gas, electrolytes, metabolites, and


CO-oximetry parameters on a blood gas analyzer play a
very important role in emergency situations because these pro- Parameter Analytical Method
Range of
Indication Units
vide information on the critically ill patient’s status leading to pH Potentiometric 6.3Y8.0
immediate and effective patient care. These tests have tradi- measuring principle
tionally been performed in the central laboratory but are now PCO2 Potentiometric 5Y250 mm Hg
moving out of the laboratory to be performed near the patient in measuring principle
the point-of-care (POC) hospital environment. This has gener- PO2 Oxygen ability to reduce 0Y800 mm Hg
ated a need for new technologies and design of blood gas ana- the intensity and time
lyzers to fulfill the requirements of the POC testing. Some of the of phosphorescence
requirements1 in POCT are high-quality and equal analytical from a phosphorescent
performance and reliability as traditional laboratory analyzers, dye (quenching)
small footprint, simple operation and maintenance procedures, K+ Potentiometric 0.5Y25 mM
short turnaround time, small sample volume, quality controls, and measuring principle
compatibility with the hospital information technology systems. Na+ Potentiometric 7Y350 mM
It is also important to have relatively little training and man- measuring principle
agement of these analyzers because many nonYlaboratory- Ca2+ Potentiometric 0.2Y9.99 mM
trained personnel in a wide variety of POC locations must use measuring principle
them safely. Clj Potentiometric 7Y350 mM
Recently, the ABL90 FLEX analyzer was introduced, which measuring principle
is a POC cartridge-based blood gas analyzer with a replaceable Glucose Amperometric 0Y60 mM
sandwich sensor cassette measuring pH, PO2, PCO2, Na+, K+, measuring principle
Ca2+, Clj, glucose and lactate. Integrated in the analyzer is an Lactate Amperometric 0Y30 mM
oximetry module measuring tHb, SO2, O2Hb, HHb, COHb, measuring principle
MetHb, FHb, and bilirubin. tHb Spectrophotometry 0Y27 g/dL
A sample of 65 KL of whole blood is required for a full- SO2 Spectrophotometry 0Y100 %
parameter profile with a measuring time of 35 seconds. The O2Hb Spectrophotometry 0Y100 %
HHb Spectrophotometry 0Y100 %
COHb Spectrophotometry 0Y100 %
From the Radiometer Medical ApS, Broenshoej, Denmark. MetHb Spectrophotometry 0Y100 %
Reprints: Corina Seeger, MSc, Radiometer Medical ApS, Aakandevej 21, HbF Spectrophotometry 0Y100 %
DK-2700 Broenshoej, Denmark. E-mail: corina.seeger@radiometer.dk. Bilirubin Spectrophotometry 0Y1000 KM
The manufacturer, Radiometer Medical Aps, employs all the authors.
Copyright * 2011 by Lippincott Williams & Wilkins Analytical method and range of indication.
ISSN: 1533-029X

108 Point of Care & Volume 10, Number 3, September 2011

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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

Parameter Comparison Method n Mean Difference Deming’s Regression Sy.x


pH ABL735 127 0.0046 y = 0.9895x + 0.0815 0.0043
ABL835 FLEX 127 0.0038 y = 0.9807x + 0.1459 0.0047
ABL80 FLEX CO-OX 123 j0.0053 y = 0.9800x + 0.1424 0.0107
PCO2 ABL735 127 0.1218 y = 0.9693x + 1.5440 0.8435
ABL835 FLEX 127 j0.1531 y = 0.9650x + 1.4736 0.9397
ABL80 FLEX CO-OX 123 j1.3750 y = 0.9739x j 0.1442 1.5554
PO2 ABL735 127 j0.5785 y = 1.0140x j 2.2812 2.8829
ABL835 FLEX 127 j2.3913 y = 0.9968x j 1.9909 2.6289
ABL80 FLEX CO-OX 120 0.4468 y = 1.0095x j 0.7051 3.8612
K+ ABL735 89 0.0838 y = 1.0124x + 0.0234 0.0732
ABL835 FLEX 89 j0.0224 y = 1.0031x j 0.0376 0.0423
ABL80 FLEX CO-OX 87 0.0851 y = 1.1207x j 0.5044 0.0981
Na+ ABL735 90 1.5129 y = 1.0544x j 6.1521 0.7276
ABL835 FLEX 90 1.1379 y = 1.0541x j 6.5058 0.8197
ABL80 FLEX CO-OX 88 1.0781 y = 1.1351x j 18.0162 2.1250
Ca2+ ABL735 90 0.0173 y = 1.0457x j 0.0444 0.0204
ABL835 FLEX 90 0.0163 y = 1.0560x j 0.0594 0.0211
ABL80 FLEX CO-OX 90 0.0679 y = 1.1527x j 0.1308 0.0552
Clj ABL735 90 j0.2151 y = 0.9865x + 1.3335 1.0031
ABL835 FLEX 90 0.3724 y = 1.0145x j 1.2840 0.9695
ABL80 FLEX CO-OX 87 j2.6375 y = 1.0477x j 8.2321 2.2478
Glucose ABL735 119 0.2582 y = 1.0243x j 0.0137 0.3570
ABL835 FLEX 118 0.4807 y = 1.0724x j 0.3201 0.6523
ABL80 FLEX CO-OX 119 j0.2006 y = 1.0013x j 0.2158 0.7639
Lactate ABL735 119 0.0220 y = 1.0170x j 0.0496 0.1360
ABL835 FLEX 118 0.1560 y = 1.0443x j 0.0257 0.3229
ABL80 FLEX CO-OX
tHb ABL735 250 0.1463 y = 0.9875x + 0.3369 0.1353
ABL835 FLEX 249 0.2495 y = 0.9899x + 0.4031 0.1568
ABL80 FLEX CO-OX 248 0.0415 y = 1.0130x j 0.1574 0.2774
SO2 ABL735 285 j0.1743 y = 0.9987x j 0.0656 0.2920
ABL835 FLEX 285 j0.0772 y = 0.9989x + 0.0159 0.2721
ABL80 FLEX CO-OX 278 j0.2273 y = 0.9997x j 0.2040 0.6125
O2Hb ABL735 285 0.2736 y = 1.0037x j 0.0160 0.4092
ABL835 FLEX 284 0.4155 y = 1.0043x + 0.8023 0.4005
ABL80 FLEX CO-OX 278 0.1770 y = 1.0038x j 0.1226 0.7350
HHb ABL735 285 0.1243 y = 0.9963x + 0.1770 0.2697
ABL835 FLEX 285 0.0386 y = 0.9964x + 0.0905 0.2548
ABL80 FLEX CO-OX 278 0.2227 y = 0.9994x + 0.2302 0.6027
COHb ABL735 254 j0.5135 y = 0.9975x j 0.5020 0.4147
ABL835 FLEX 253 j0.4846 y = 0.9947x j 0.4604 0.3571
ABL80 FLEX CO-OX 253 j0.4621 y = 0.9998x j 0.4613 0.2177
MetHb ABL735 254 0.0406 y = 0.9955x + 0.6058 0.2346
ABL835 FLEX 253 j0.0261 y = 0.9940x + 0.0015 0.2411
ABL80 FLEX CO-OX 253 0.0458 y = 0.9931x + 0.0768 0.2799
n indicates number of samples analyzed; Sy.x, standard error of estimate.

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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

Blood gas, pH, and oximetry were measured in capillary


mode using samples from 250-KL glass capillary tubes (for TABLE 3. Imprecision Data: ST and % CV on All Parameters
ABL80 FLEX CO-OX capillary adapters were used). All other Analyzed on the ABL90 FLEX Analyzer
parameters were analyzed in syringe mode using samples from Parameter Unit Level Mean ST CV %
syringes. The evaluation was conducted at the Metrology section
at Radiometer Medical ApS (Broenshoej, Denmark). pH 7.1 0.0028
For each parameter, 3 to 5 levels were tested in duplicate. 7.2 0.0024
Each level was tested with 2 runs per day on 8 different days on 7.4 0.0026
the ABL90 FLEX, ABL835 FLEX, ABL735, and ABL80 FLEX 7.6 0.0086
CO-OX analyzers (Radiometer Medical ApS) within a test pe- PCO2 mm Hg 29 0.35 1.21
riod of 30 days. The test was performed according to the oper- 40 0.37 0.93
ator instructions from the operator manuals for each analyzer. 60 0.56 0.93
Four levels of quality control (QUALICHECK5+; Radi- 80 1.08 1.35
ometer Medical ApS) were measured twice a day to determine PO2 mm Hg 40 1.57 3.93
the between-day precision. Furthermore, certified reference ma- 90 0.77 0.86
terial from the NIST (SRM956b for electrolytes and SRM965a 140 1.5 1.07
for glucose) were included in the study. 160 2.61 1.63
All calculations were performed according to CLSI EP5-A2 230 1.58 0.69
guidelines.3 Data were computerized and analyzed using SAS K+ mM 2 0.062 3.10
jump version 8.0.2. 4 0.062 1.55
8 0.071 0.89
ABL90 FLEX Analyzer and Sensor Description Na+ mM 120 0.45 0.38
The ABL90 FLEX analyzer is designed with a short sample 140 0.69 0.49
flow path connecting the following modules: an inlet separated 160 0.90 0.56
from the cassettes, a sensor cassette with a smart chip (all nec- Ca2+ mM 0.6 0.020 3.33
essary information is loaded into the analyzer when installed), a 1.2 0.013 1.08
miniature oximeter, a solution cassette with a smart chip, and one 2.4 0.023 0.96
pump. Furthermore, the analyzer has a sample mixer, a touch Clj mM 95 0.77 0.81
screen, user guide software, a scanner, and a printer. 110 0.91 0.83
The sensors are based on thick-film technologyVceramic 140 1.33 0.95
substrate with printed layers forming microelectrodes and com- Glucose mM 2 0.05 2.50
pleted with dispensed membranes. The new sensor technology 6 0.13 2.17
combined with the sandwich concept has made it possible to 15 0.34 2.27
achieve the small sample volume of only 35 KL in the sensor 25 0.61 2.44
cassette. The sensors are distributed on 2 sensor arrays placed in Lactate mM 0.6 0.05 8.33
the sensor cassette, facing each other and forming the measur- 1.7 0.07 4.12
ing chamber that allows measurement from both sides of the 5 0.14 2.80
blood sample at the same time. The reference electrode is based 10 0.23 2.30
on the membrane junction principle. tHb g/dL 7 0.14 2.00
The analyzer requires only 65 KL of whole blood for a full- 15 0.08 0.53
parameter profile and reports up 17 parameters (Table 1). In ad- 25 0.14 0.56
dition, the analyzer reports up to 46 calculated parameters4 with SO2 % 0 0.13
the main ones being HCO3j, base excess, anion gap, and Hct. 70 0.20 0.29
The optimized and miniaturized ABL90 FLEX analyzer 100 0.14 0.14
sensor allows a more rapid sensor response with a measuring time O2Hb % 0 0.13
of 35 seconds and a cycle time of 60 seconds. The analyzer per- 70 0.23 0.33
forms an automatic calibration before each measurement to re- 80 0.18 0.23
duce sensor drift, thereby limiting the amount of prescheduled 90 0.17 0.19
calibrations, which extends the solution-pack lifetime and max- 100 0.28 0.28
imizes the analyzer uptime. HHb % 0 0.14
0.5 0.08 16.00
30 0.2 0.67
100 0.18 0.18
RESULTS
COHb % 1.0 0.15 15.00
Accuracy 1.7 0.12 7.06
The analytical performance of the ABL90 FLEX analyzer 10 0.09 0.90
correlated with the ABL835 FLEX, ABL735, and ABL80 FLEX 20 0.09 0.45
CO-OX analyzers for all the tested parameters with an R2 = MetHb % 0.6 0.14 23.33
0.980Y1.000 (data not shown). Data were supported by Deming’s 0.8 0.13 16.25
regressions (Table 2), which did not indicate any difference be- 1 0.15 15.00
tween the results of the ABL90 FLEX analyzer and the ABL835 10 0.25 2.50
FLEX, ABL735, and ABL80 FLEX CO-OX analyzers. 20 0.12 0.60
The standard error of the estimate (Sy.x) obtained from linear 100 0.18 0.18
regression (Table 2) were for pH (0.004Y0.011); PCO2 and PO2 ST indicates total variations.
(0.84Y3.86 mm Hg); K+, Na+, Ca2+, and Clj (0.02Y2.25 mM);

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Point of Care
TABLE 4. QUALICHECK5+ Measurements on the ABL90 FLEX Analyzer

QUALICHECK5+ Level 1 QUALICHECK5+ Level 2

&
Radiometer Radiometer
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Volume 10, Number 3, September 2011


Insert Control RiliBÄK Insert Control
Parameter Units Concentration Mean Bias RiliBÄK Limits (+/j) Limits (+/j) Concentration Mean Bias Limits (+/j) Limits (+/j)
pH 7.075 0.0002 0.0283 0.02 7.391 j0.0001 0.0295 0.02
PCO2 mm Hg 69.4 j1.228 4.511 5 40.6 j0.254 2.639 3
PO2 mm Hg 151 j0.435 8.305 10 99.2 j1.405 6.944 8
K+ mM 1.9 j0.150 0.3 0.3 3.9 j0.161 0.176 0.3
Na+ mM 162 j0.214 4.86 4 140 0.511 4.2 4
Ca2+ mM 0.99 0.009 0.139 0.1 0.53 0.003 0.074 0.1
Clj mM 123 j0.591 5.535 6 97 0.780 4.365 6
Glucose mM 1.7 0.045 0.5 0.5 5.6 0.142 0.616 0.8
Lactate mM 4.3 0.062 0.473 0.6 1.7 j0.038 0.187 0.5
tHb g/dL 8.1 0.068 0.324 0.5 12.9 0.063 0.516 0.6
SO2 % 50 j0.031 1 1 97.2 j0.227 1.0 1
O2Hb % 44.5 0.031 1 1 92.2 j0.077 1.0 1
COHb % 6.1 j0.172 1.5 1.5 3.2 j0.233 2.0 2
MetHb % 5 0 1 1 1.9 0.123 1.0 1

QUALICHECK5+ Level 3 QUALICHECK5+ Level 4

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+

Analytical Performance of ABL90 FLEX


mM 126 0.342 3.78 4 120 0.305 3.6 4
Ca2+ mM 0.59 j0.005 0.084 0.1 1.59 0.011 0.119 0.1
Clj mM 64 2.157 6.0 6 23 0.27 6 6
Glucose mM 13.8 0.282 1.518 1.8 j0.2 j0.088 0.4 0.4
Lactate mM 10.6 j0.518 1.166 1.2 j0.2 j0.072 0.4 0.4
tHb g/dL 19.4 0.063 0.776 0.7 2.5 0.099 0.1 0.4
SO2 % 70.4 j0.119 1.0 1 5 0 1 1
O2Hb % 48.8 0.05 1.0 1 3.5 0 1 1
COHb % 20.8 j0.272 1.5 1.5 10 j0.032 1 1
MetHb % 10 0.046 1.0 1 19.9 0 1 1
113
Seeger et al Point of Care & Volume 10, Number 3, September 2011

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.

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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
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