EVALUATION OF THE KONELAB 20i CLINICAL CHEMISTRY ...

EVALUATION OF THE KONELAB 20i
CLINICAL CHEMISTRY ANALYZER
Juutilainen, P. 1 , Seppälä, K. 2 , Lampinen, H. 3
1Clinical Laboratory, Municipal Health Center, Pori, Finland
2Clinical Laboratory, Joint Municipal Authority for Public Health Work, Kankaanpää, Finland
3Labsystems Clinical Laboratory Division, Espoo, Finland
Abstract
Konelab 20i is a new, selective clinical chemistry analyzer for routine clinical chemistry tests,
specific proteins, DoA, TDM, toxicology tests and electrolytes. Methods applied are colorimetric
and turbidimetric as well as direct potentiometry for electrolyte measurement. Theoretical
throughput of the analyzer is up to 200 photometric and 180 ISE tests/hour. The analyzer is
capable of handling both routine and stat requests.
Konelab 20i was evaluated according to guidelines given by ECCLS and modified by Labquality
(Finland) to meet with local requirements. Nine tests (K, Na, Cl, Li, ALT, ALP, CRP, Chol and
Uric Acid) were evaluated and results were compared to those obtained with Cobas Mira,
Konelab 60i (Cl), KONE Microlyte (Li) and Eppendorf Efox 5053 (Li) analyzer. Results of all
evaluated tests showed a good correlation.
Calibrations and daily routines were performed according to recommendations of the
manufacturer. A calibration interval of two weeks was recommended for CRP and Cholesterol
assays, and one month for Uric Acid and electrolytes. During the whole calibration period, no
significant long-term drift was found.
Within-run imprecision (CV%) was calculated from patient samples measured as duplicates.
Coefficients of variation were below 1% for K, Na, and Cl and Lithium at high level. For ALP,
Cholesterol and Uric Acid CVs below 2% were obtained. CRP gave 2.6% for high level samples
and 7.9% for low levels. For ALT results CVs between 9.6 and 3.4% were observed.
Between-run imprecision (CV%) was below 3.5 % for all tests, except CRP.
No sample or reagent carry-over was found.
Instruments
Konelab 20i (Labsystems Clinical Laboratory Division, Espoo, Finland) is random access, selective
clinical chemistry analyzer. The number of on-board sample positions is 84 plus 6 stat samples. Samples
are placed on continuous loading segments. Integrated barcode reader and cup type recognition for
samples are included. Sample tubes of 5 ml, 7 ml and 10 ml with tailored segments can be used, as well
as 0.5 ml and 2 ml analyzer cups. Sample volume is from 1 to 120 µl, typically 2-15 µl for photometric
tests and 50 µl fo Na + , K + and Cl - .
The refrigerated reagent disk has continuous loading positions of 35 vessels that can be 10, 20 or 60 ml.
The reagents can be identified with external barcode reader. The real time reagent status is seen on the
workstation window. The reagent volumes are 2-250 µl, up to four reagent additions per test is possible.
The reaction cuvette for photometric tests is a discrete multicell cuvette with 12 square reaction cells in
a row. Cuvettes can be loaded continuously. The on-board capacity is 50 multicell cuvettes, which
means 600 reaction positions. Reaction end volume is from 100 to 250 µl.
Automatic sample pre- and re-dilutions between 1:1 and 1:120 is available. Calibration with separate
calibrator samples or with automatically diluted series from a stock calibrator is possible. Linear, nonlinear
and bias calibrations as well as several blank possibilities can be used.
Real time QC function is available including multiple and variable (Westgard) rules and chart printouts
both daily and cumulative basis. The control intervals are programmable.
The photometer is a single channel system with beam splitting reference and interference filters between
340 and 700 nm.
For comparison with the Konelab 20i were used the following analyzers:
Cobas Mira (Roche Diagnostics, Basel, Switzerland)
Eppendorf EFOX 5053 (Eppendorf-Netheler-Hinz GmbH, Hamburg, Germany)
Konelab 60i (Labsystems Clinical Laboratory Division, Espoo, Finland)
KONE Microlyte (Labsystems Clinical Laboratory Division, Espoo, Finland)

Materials and methods
The methods and reagents used in this study are summarized in Table 1.
Reagents used in Konelab 20i were prepared according to the instructions of the manufacturer. They
were stored in the analyzer’s refrigerated reagent compartment.
Reagents for Cobas Mira were stored between analysis sections in the refrigerator at + 4 o C.
Calibrators and recommended calibration intervals are given in Table 2.
Materials used for between-run imprecision study are given in Table 4.
For the entire evaluation, all control samples were dissolved at the same time and stored in 1 ml aliquots
at –20 o C.
Patient samples, minimum 81 for each analyte representing low, medium and high levels of measuring
range were collected and stored at –20 o C. They were analyzed as duplicates in Konelab 20i. A single
determination was performed at the same time in Cobas Mira, or on the same day in Konelab 60i or
KONE Microlyte. Lithium samples were measured first in Eppendorf EFOX, then stored at –20 o C until
analyzed on the same day in KONE Microlyte and Konelab 20i.
Double determinations in Konelab 20i were used to calculate the within-run imprecision. In the
comparative study with other instruments the first of duplicate values was used in regression analysis.
The sample carry-over was studied with low and high level patient sera using Uric Acid (low level
sample 105 µmol/l and high level sample 675 µmol/l) and C-Reactive Protein (low level sample 21 mg/l
and high level sample 207 mg/l) tests.
The reagent carry-over was studied using Lactate Dehydrogenase (240 U/l) and Alanine
Aminotransferase (31 U/l) tests.
Table 1. Tests, methods and reagents used in evaluation
Konelab 20i Cobas Mira
Test Method Method
Potassium ISE, direct measurement ISE, direct measurement
Sodium ISE, direct measurement ISE, direct measurement
Chloride ISE, direct measurement ISE, direct measurement /Konelab 60i
Lithium ISE, direct measurement ISE, direct measurement /KONE Microlyte
ISE, direct measurement Flame emission / Eppendorf EFOX 5053
ALP SCE, DEA-buffer
Kinetic
Konelab 981359
ALT IFCC/ECCLS
Kinetic
Konelab 981361
C-Reactive
Protein
Immunoturbidimetry
End-point with sample blank
Konelab 981666
Cholesterol CHOD
End-point with reagent blank
Konelab 981368
Uric acid Uricase, Trinder (AOX)
End-point with reagent blank
Konelab 981391
SCE, DEA-buffer
Kinetic
Medix Biochemica 0054
IFCC/ECCLS
Kinetic
Medix Biochemica 0558
Immunoturbidimetry
End-point with sample blank
Orion Diagnostica 67393 and 67179
CHOD
End-point with reagent blank
Konelab 981368
Uricase, PAP
End-point with reagent blank
Roche 0736813

Table 2. Calibrators and recommended calibration intervals of the analytes
Konelab 20i Cobas Mira
Analyte Calibrator Cal. Interval Calibrator Cal. Interval
Potassium ISE Cal 1
Every assay ISE Standard 1, 07 2568 4 Every assay
Sodium Konelab 984031
ISE Standard 2, 07 2569 2 240 min interval
Chloride
See Konelab 20i *
See Konelab 20i *
Standard Solution 1, 980796
Standard Solution 2, 980797
Every assay
Lithium
Standard Solution 3, 980798 ** 240 min interval **
ISE Cal 2 ja 3
One month System Blank Sol. 0030 340.000 At the start and
Konelab 984035
Serum Standard 0030 311.000 *** then every 10 min ***
ALP Factor (molar absorptivity) - Factor (molar absorptivity) -
ALT Factor (molar absorptivity) - Factor (molar absorptivity) -
C-Reactive CRP Calibration Set Two weeks CRP Calibrator Set
When the antisera lot
Protein Konelab 981674
Orion Diagnostica 68090 changes
Cholesterol Calibrator 2
Three weeks Seronorm Lipid
Two weeks
Konelab 980502
Sero
Uric acid Calibrator 1
One month Biocal
Every day
Konelab 980501
Bioclin
* = Konelab 60i
** = Kone Microlyte
*** = Eppendorf EFOX 5053
Results
Imprecision
The within-run imprecision was better than 1 % in ISE measurements with exception of Lithium at low levels.
For Alkaline Phosphatase, Cholesterol and Uric Acid CVs below 2 % were obtained. C-Reactive Protein gave
2.6 % for medium and high level samples and 7.9 % for low level. For Alanine Aminotransferase results CVs
between 9.6 and 3.4 % were observed.
Between-run imprecision (CV%) was below 3.5 % for all tests, except C-Reactive Protein.
The results are presented in Tables 3 and 4.
Carry-over
No sample or reagent carry-over was found.
Correlation
The regression analysis of the results are presented in Figures 1-10.
The correlations were very good. A bias of 5 to 15 % was found in the results of Lithium assays. Also a
significant bias of 10 to 20 % was found for Alkaline Phosphatase results.

Table 3. Within-run imprecision
Calculated from duplicate determinations of patient samples
Analyte Mean SD CV% n
Potassium 3,73 0,013 0,4 28
(mmol/l) 4,35 0,032 0,7 29
5,49 0,030 0,6 28
Sodium 138,7 0,435 0,3 29
(mmol/l) 143,4 0,447 0,3 30
147,3 0,465 0,3 30
Chloride 92,2 0,316 0,3 30
(mmol/l) 99,8 0,835 0,8 28
107,2 0,381 0,4 31
Lithium 0,49 0,008 1,6 34
(mmol/l) 0,74 0,007 0,9 33
1,00 0,005 0,5 33
ALP 109,9 0,972 0,9 27
(U/l) 180,7 2,639 1,5 27
525,6 7,185 1,4 27
ALT 7,7 0,736 9,6 36
(U/l) 22,7 0,779 3,4 28
59,3 2,899 4,9 26
CRP 5,7 0,451 7,9 27
(mg/l) 42,0 1,086 2,6 28
148,4 3,824 2,6 28
Cholesterol 4,36 0,060 1,4 29
(mmol/l) 5,80 0,091 1,6 29
7,62 0,149 2,0 31
Uric acid 221,4 1,824 0,8 29
(µmol/l) 379,0 3,284 0,9 30
522,8 6,927 1,3 31

Konelab 20i (mmol/l)
8,0
7,5
7,0
6,5
6,0
5,5
5,0
4,5
4,0
3,5
3,0
2,5
2,0
Table 4. Between run imprecision
Analyte Sample Mean SD CV% n
Potassium Pathonorm L 2,195 0,041 1,8 19
(mmol/l) Pathonorm H 6,432 0,089 1,4 19
Pooled sera C 4,616 0,083 1,8 19
Sodium Pathonorm L 125,8 2,069 1,6 17
(mmol/l) Pathonorm H 159,3 1,961 1,2 17
Pooled sera C 150,3 2,443 1,6 17
Chloride Pathonorm L 73,6 1,688 2,3 18
(mmol/l) Pathonorm H 128,1 3,334 2,6 18
Pooled sera C 110,8 2,243 2,0 19
Lithium Nortrol 0,95 0,018 1,9 17
(mmol/l) Abtrol 2,46 0,050 2,0 18
Pathonorm H 1,61 0,037 2,3 18
ALP Pathonorm L 167,6 5,512 3,3 16
(U/l) Pathonorm H 630,9 21,020 3,3 16
Pooled sera C 166,8 4,328 2,6 16
ALT Pathonorm L 32,2 1,098 3,4 18
(U/l) Pathonorm H 105,3 2,697 2,6 18
Abtrol 124,5 3,365 2,7 18
CRP CRP Control 29,8 1,437 4,8 17
(mg/l) CRP C. High 82,8 3,192 3,9 17
Pooled sera V 157,5 10,696 6,8 15
Cholesterol Pathonorm L 3,19 0,025 0,8 16
(mmol/l) Pathonorm H 6,91 0,209 3,0 17
Pooled sera C 5,68 0,064 1,1 17
Uric acid Pathonorm L 177,6 2,910 1,6 19
(µmol/l) Pathonorm H 574,1 8,689 1,5 19
Pooled sera C 343,2 5,105 1,5 19
Where: 1) Pathonorm L (Sero), Lot 703078
2) Pathonorm H (Sero), Lot MI8128x
3) Pooled sera (PKS), Lot C, normal values
4) Nortrol (Konelab Corp.), Lot 4165F
5) Abtrol (Konelab Corp.), Lot 4205E
6) CRP Control (Konelab Corp.), Lot 1586
7) CRP Control High (Konelab Corp.), Lot 1576
8) Pooled sera (PKS), Lot V, high CRP-level
Potassium
y = 1.069x – 0.242
R 2 = 0.983 n = 85
2,0 2,5 3,0 3,5 4,0 4,5 5,0 5,5 6,0 6,5 7,0 7,5 8,0
Cobas Mira (mmol/l)
Konelab 20i (mmol/l)
160
155
150
145
140
135
130
125
120
Sodium
y = 0.913x + 12.448
R 2 = 0.888 n = 89
120 125 130 135 140 145 150 155 160
Cobas Mira (mmol/l)

Konelab 20i (mmol/l)
Konelab 20i (mmol/l)
130
120
110
100
90
80
70
1,6
1,4
1,2
1,0
0,8
0,6
0,4
0,2
0,0
Chloride
y = 0.957x + 3.738
R 2 = 0.929 n = 89
70 80 90 100 110 120 130
Konelab 60i (mmol/l)
Lithium
y = 0.968x + 0.068
R 2 = 0.986 n = 100
0,0 0,2 0,4 0,6 0,8 1,0 1,2 1,4 1,6
Microlyte (mmol/l)
Konelab 20i (mmol/l)
1,6
1,4
1,2
1,0
0,8
0,6
0,4
0,2
0,0
Lithium
y = 0.966x + 0.080
R 2 = 0.995 n = 83
0,0 0,2 0,4 0,6 0,8 1,0 1,2 1,4 1,6
Eppendorf EFOX 5053 (mmol/l)

Konelab 20i (U/l)
Konelab 20i (mg/l)
1200
1000
800
600
400
200
0
400
350
300
250
200
150
100
50
0
ALP
y = 1.098x + 14.688
R 2 = 0.994 n = 81
0 200 400 600 800 1000 1200
Cobas Mira (U/l)
CRP
y = 1.067x – 4.991
R 2 = 0.991 n = 83
0 50 100 150 200 250 300 350 400
Cobas Mira (mg/l)
Konelab 20i (U/l)
Konelab 20i (mmol/l)
200
180
160
140
120
100
80
60
40
20
0
12
11
10
9
8
7
6
5
4
3
2
ALT
y = 1.037x – 1.180
R 2 = 0.990 n = 90
0 20 40 60 80 100 120 140 160 180 200
Cobas Mira (U/l)
Cholesterol
y = 0.930x + 0.277
R 2 = 0.998 n = 89
2 3 4 5 6 7 8 9 10 11 12
Cobas Mira (mmol/l)

Konelab 20i (umol/l)
700
600
500
400
300
200
100
0
Conclusions
The Konelab 20i demonstrated very good analytical performance throughout the evaluation. Correlations to
routine methods in the laboratory were excellent as well precisions.
The Konelab 20i analyzer with Konelab reagents turned out to be a cost-efficient and user-friendly analyzing
system with many features for easy and self-guiding operation. The main routines, loading of samples, reagents
and reaction cuvettes can be performed without any workload interruptions. The analyzer demands very few
maintenance operations daily.
We concluded that Konelab 20i is a reliable analyzer for small- to medium-sized laboratories.
References
Uric acid
y = 0.979x + 21.808
R 2 = 0.976 n = 90
0 100 200 300 400 500 600 700
Cobas Mira (umol/l)
1. Kaihola, H.-L., Rintola, P. and Sandbacka, B: Pienten laboratorioiden kliinisen kemian analysaattorin
koestusohjelma, Moodi 1990: 3: 176-185
Laboratory Medicine 2000, XXVII Nordic Congress of Clinical Chemistry, Bergen, Norway, 4-8 June 2000