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Evaluation Konelab20xt

Evaluation Konelab20xt

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Clin Chem Lab Med 2005;43(6):646-653 © 2005 by Waller de Gruyter • Berlln • New York. DOl 10 1515fCCLM. 2005.111

Evaluation of the Konelab 20XT clinical chemistry analyzer

Natasa Stcjanovie", Dunja Rogie· ... and Ana Stavljenie-Hukavina"

1 Faculty of Pharmacy and Biochemistry, University of Zagreb, Zagreb, Croatia

l Clinical Institute of Laboratory D.iagnostics,

Clinical Hospital Center Zagreb and Medical School, Un ive rs ity of Za g rIO b, Zag reb, Cro atia


The Konelab 20XT (Thermo Electron Ov, Finland) is a clinical chemistry analyzer for colorim etric, im munotu rbi dim err i c an d i 0 n-se lective 101 ectro d e mea s u rements. The aim of our work was to evaluate the analytical performances of the Konelab 20XT according to the European Clinical Chemistry Laboratory Standards Gu idelines. A total of 30 analvtes incl uding substrates, enzymes, electrolytes and specific proteins were tested. Investigation results showed low imprecision (with in-run coefficient of variation was below 3.5% and between-day coefficient of variation was I ess than 2.5% for most an alytes at all three lev· els studied) and acceptable accu racy of the analyzer. No siqniticant sample- or reagent-related carry-over was found. It was demonstrated, that the analytical system operates within the claimed linearity ranges. The results compared well With those obtained by instruments routinely used in ou r laboratory (Olympus AU2700, Behring, Nephelometer 1,1). In general, the data on interference by hemoglobin, hyperbil irubinemia and turbi dity a re in accordance with known facts. However, slight hemolysis was found to interfere with the alkal ine phosphatase IALP) assay and mild I ipernia affected the glucose assay. The Konelab 20XT is an easy-to-use analyzer that is su itable for routine and em erg ency an alyses in small I a bo rato ri lOS.

Keywords: evaluation: rrnprecrsion: inaccuracy;

instrument comparison; interference.

I ntro d u ction

The Konelab 2QXT IThermo Electron Oy, Vantaa, Finland) is a clinical ch.emistry analyzer for colorimetric, immunoturbidimetric and ion-selective electrode measurements. The aim of our work was to evaluate the analytical performance of the Konelab 20XT in the clinical setting according 10 the Eu ropean CI inical Chemistry Laboratory Stands rds (ECCLSI Guidelines 11). The study was carried au! ina single laboratory

~Corresponding author: Dunja Rogie, PhD. Clinical Institute of La boratory Dia 9 nostics, CI in ica I Hospi ta I C9 nrer Za 9 reb, 10000 Zagreb. Croatia

Phone +385-1-23-88-380, Fax: +385-1-23-12-079. E-mail: dUrljarogic@hotmail.com

due to the lack of any other instrument in the area HOwever, the analyzer has not been evaluated previously and we think that our study might represent an important reference for anyone interested in its performance. A total of 30 analvtes were correlated with other instru ments and tested for imprecision. inaccuracy, 'linearity and interferences, which makes this study a relevant data base on this su bjsct.

Descripti 0 n of the i nst ru m ent

The Konelab 20XT is a random access analyzer designed for routine and' special biochemistrv analyses, incl udi ng specific proteins, therapeutic dru gs and d rugs of abuse. Analytical methods used on the analyzer are colorimetry, immunotu rbidimetry and direct potentiometry liSE). The ISE unit includes Na . , K~ and CI- electrodes, while a Li " electrode is available upon request. Low-maintenance electrode assembly allows direct measurement of electrolytes sim ultaneously. Ready-to-use reagents are pi aced on a cooled reagent disc with 35 positions, which represent all the available positions within Iheinstrument. Therefore, the actual nu m ber of teSTS that could be performed on the instrument simultaneously depends on th e number of m ulticomponent reagents. Real-time mon itoring of reagent usage an d the abilitv to add reagents without workflow interruption makes the reagent system conven ient to use. Sampl as can also be loaded continuously. There a rIO six segments. each with 14 sample positions and five additional positions for STAT samples. The STAT sam pies may be loaded together with the routine sampl as in the segments or into the STAT positions. The sarnoies. calibrators and controls are placed on a sample disk in the segments. Reactions are performed at 37"C in di screte dis posa bl 10 m u I ti cell cuvett es with 1 2 re acti on measurement cells. The typica I reaction volume of the cuvette cell is 120-150 f-LL The possible range for the sample volume is 1-120 f-LL (typicall.y 2-15f-LLl. The dead vol ume is 50 f-L L. Predil ution of patient sarnpl e5. and postdilution with high and low secondary di I ution ratios are handled autorn aticallv, The optical system consists of a singl.e-channel interference filter photometer with a beam spl itting reference (spectral range 340-800 n rn). A self-gu iding gra phical interface based on the Microsoh"" Windows'" XP Professional sorrware is USed, so routine analyses and data managem ent are easv, Up to 200 different appl ications are possible. Theoretical workload-dependent through put claimed by the manufactu rer is up to 250 tests per hour.

Materials and methods

A total 01 30 analvres were tested on the Kcnelab 20XT analyzer with the reagents and calibrators provided by Thermo

Stcjanovic et al.: Evaluation 01 the Konelab 20XT clinical chemistry analyzer 647



Table 1 Methods and calibrators used for analvtas measured on the Konelab 20XT analyzer.





AST Calcium Cholesterol CK Creatinine CBll

GGT Glucose lDH Magnesium

I no rga nic ph os p horus Total bilirubin

Total protein Triglycerides

Uric acid










DirBC! potentiornetrv IFCC

IFCC without pyridoxal phosphate Blocked substrate E-pNPG,

IFCC without pyridoxal phosphate Arsenazo III cornplexone CHOD-PAP


Jaffe kinetic Malloy·Evelyn liquid stand. Szasz GOD·PAP


Arsenazo complexone Molybdate Malloy-Evelyn



Uricase-PAP Urease·GlDH Immunoturbidimetry Immunoturbidimetry 1m m u noturbi d i metry Immunoturbidimetry Immunoturbidimetry Immunowrbidimetry Immunoturbidimetry 1m m un oIU rbidi metry

ISE calibrators (Thermo)

Olympus System Calibrator (Olympus I Olympus System Ca librator 10lympus) Olympus System Calibrator 10lympus) Olympus System Calibrator (Olympus) Olympus System Calibrator 10lympusi Olympus System Calibrator 10lympus) Olympus System Calibrator (Olvrnpus) Olympus System Calibrator (Olympus) Olympus System Calibrator 10lympus) Olympus System Calibrator 10lympus) Olympus System Calibrator (Olympus) Olympus System Calibrator 10lympus) Olympus System Ca libraror 10lympusi Olympus System Calibrator (Olympus) Olympus System Calibrator (Olympusi Olympus System Calibrator (Olympus) Olympus System Calibrator (Olympus) Olympus System Calibrator (Olympus) Olympus System Calibrator (Olympus) SpeciCal Protein Calibrator (Thermo) SpecrCal Protein Calibrator IThermo) CRP Calibrator Set (Thermo)

HbA,JHb Calibrators rThermo) SpeciCal Protein Calibrator (Thermo) SpeciCal Protein Calibrator (Thermo) SpeciCal Protein Ca librator (Thermo) RF Calibrator (Thermo)

Electron Oy (Table 1 I. Calibration of substrates [bilirubin, cholesterol, creatinine, glucose (GlC), total protein, trigly· cerides, uric acid and urea]. as well as calcium, magnesium and inorganic phosphorus were performed using an Olvrnpus System Calibrator (Olympus Diagnostica GmbH, l.ismeehan, Ireland). Enzyme activities were calculated through manual factor entry. Two commercial control samples (Precinorm" U, Lot 162576 and Precipath" U, lot 161011, Roche Diagnostics, Indianapolis, USA) and a pool sample prepared from fresh frozen human sera obtained from blood donors were used for all analvtes except for specific proteins. Analyses of specific proteins were carried out with appropriate commercial control sera manufactured by Thermo Electron 01': SpeciTrol/SpeciTrol High (complement 3 (C3). C4, immunoglobulin A (lgAl. IgG, IgM], C-reactive protein (CRP) Control/CRP Control High, rheumatoid factor (RF) Control, hemoglobin A" (HbA,eI Control Normal/Abnormal.

Data were analyzed using GraphPad Prism', Version 3.0 software (GraphPad Inc, San Diego, CA, USA).


Imprecision 01 the analytical system was determined at three levels 01 control materials for all analvtes except for specific proteins (two levels) and the RF assay (one level). For assessment of within-run imprecision of the substrates, enzymes and electrolytes, 30 repl lea tes we re mea su red 0 n 3 d iffe re nt days and the mean of three coefficients of variation ICV, %1 was calculated. Ten replicates were measured on 3 different days for the evaluation of within-run imprecision of specific proteins. Between-day imprecision was assessed during 10 days by measuring triplicates 01 the control materials (substrates, enzymes, electrolytes) and by measuring duplicates of the control materials (specific proteins). The first value of either the duplicates or triplicates was always discarded to exclude possible systematic errors due to carrv-

over effects 11) Then the remaining results were considered for calculation of between-day CV of all assays, a nd the CVs obtained on the control materials with normal concentration or activity were taken as representative of the Konelab 20XT between-day imprecision (2). These values were used for assessment of the total imprecision and inaccuracy according to the biological variation database and desirable quality specifications (3-6).


The mean values of between-day imprecision and percentage difference (bias) of the means from the target values were calculated. The values assigned to the commercial control sera were considered as the target values (4). ThB pe rlormance of the Konelab 20XT was compared with accuracy specifications defined by Fraser et al. (4) and the above-mentione d databa se 15, 6).

Reagent-related carry-over

Reagent-related carry-over was determined by measuring ala n i n e ami notr an ster a se (Al T I activi tv (reag ent conta in s high activity 01 lactate dehydrogensase (lDH), <: 1800 Ull] followed by measurement 01 lDH activity. The experiment was performed using Precipath" U control material. First. the mean of 11 replicate lDH measurements was calculated. Then, a sequence of lDH measurements preceded by the ALT measurements was repeated 21 times and the mean of the lDH results was calculated The statistical difference in these mea ns was tested using Student's t-resi.

Sample-related carry-over

Sample-related carry-over was determined according to Broughton 6t at (7). Three aliquots of a sample with high

648 Stoianovlc et al.: Evaluation of the Konelab 20XT clinical chemistry analyzer


Olympus AU2700

Table 2 Methods employed on the comparison instruments diHerent from those used on the Konelab 20XT.

Behring Nephelometer II


ALT Calcium Magnesium IgA



Indirect potentiometry

IFCC with pyridoxal phosphate IFCC with pyridoxal phosphate o-Cresotphthaleln cornplexorie Xylidyl blue

Laser nephelometry Laser nephelometry Laser nephelometry

aspartate aminotransferase (AST) activity (denoted as H" H2, H]) were followed by three aliquots of a sample with low AST activity IL" L" lJ). This sequence was repeated ten times and the mean value of the carry-over ratio (K) was calculated accordi ng to the formula: K ~ 100·(l, - L,)/(H,- L,).


To confirm that linearity ranges for substrates, enzymes and electrolytes were within the limits claimed by the manufacturer, a serum pool' with an analyte concentration encompassing or equal 10 the upper limit specified was diluted with another serum pool with an analvte concentration near the lower limit (8) A total of 11 dilutions were prepared over the stated analytical range limits and duplicate measurements of the analyte concentration were processed in a random order ~ Non-parametric reg re 55 ion Ii nes (Pa 55i ng - Babiak) were calculated (91.

Comparison with routine instruments

The analytical periormance of the Konelab 20XT was compared with that of the Olympus AU2700 clinical chemistry a natvzer (Olympus Corporation, Misnirna, Japan) and the Behring Nephelometer II (BN II; Dade Behring Marburg GmbH, Marburg, Germany). The concentrations of all anaIytes studied except for specific proteins were measured in 90 fresh patient samples on 3 successive days in parallel on the Olympus AU2700. Specific proteins were measured on the same day in 30 fresh patient samples on the Konelab 20XT and Olympus AU2700 IC3, C4, CRP, HbA" and RFI and BN II OgA, IgG, IgMI instruments. The methods used on the comparison instruments that differed from the methods used on the Konelab 20XT are specified in Table 2. The measurement results were compared by means of non-para metri cl i n ea r reg ressio n ana Iysi s I Pa ssinq-Ba blok) (9).


The effects of in vitro hemolysis, hyperbilirubinemia and lipemia on the results obtained by the Konelab 20XT were evaluated according to Glick at al. 110). For each interfering substance, a baseline serum sample was split into two aliquots. One of the aliquots was spiked either with bilirubin (Sigma-Aldrich, Milwaukee, USA; final concentration 1000 u mol/l.) or lntrafipid " 20% (Kabi Pharmacia AS, Stockholm, Sweden) or hemolvzate (final hemoglobin concentration 10 giL). lntralipid ,. 20% was used to simulate turbidity due to lipemia. The final concentration of Intralipid '" 20% added to the baseline serum was 10 giL, which corresponds to a triglyceride concentration of 28 mmolll. Then 11 dilutions were prepared by mixing appropriate volumes of the baseline and spiked serum. Triplicate measurements of the analvtes were performed and the mean values were calcuI ated. I nre rfe re nee by hyperbil i ru bi n e m i a with specific protein measurements was not tested (11, 12). Analytical results are expressed as a percentage of the values obtained in the

baseline serum. The maximum deviation allowed from the baseline serum values was set at 10%. For analvte s subject to strong homeostatic control mechanisms, and thus with a narrow plasma reference interval (sodium, potassium, calcium and magnesium), 5% was considered as the maximum deviation allowable from the baseline value.



Within-run imprecision was below 35% for all measurements except for urea (eV = 4.5%1. Between-day imprecision (eV) was less than 1.9% for CI-, K + , Na . , AL T, amylase (AMY), AST, calci urn, creatine kinase (CK), -y-glutamyltransferase (GGTl. GLC, ina rganic

Table 3 Assessment of analvtical variability of the Konelab 20XT clinical chemistry analvzer according to the qualirv specifications for total imprecision 14-6).

Analyte Coefficient of variation, %
Konelab Quality
20XT specification
Chloride 0.6 0.6
Potassium 1.4 2.4
Sodium 0.8 0.4
ALP 2.5 32
ALT 13 12.2
AMY 1.3 4.8
AST 2.3 6.0
Calcium 1.4 1.0
Cholesterol 1.3 3~O
CBIL 1.8 184
CK 17 11.4
Creatinine 2.8 2.2
GGT 1.3 6.9
GLC 2.1 2.9
lDH 1.9 4.3
Magnesium 1.5 1.8
Phosphorus 1.0 4.3
Total bilirubin 2.8 12.8
Tota I protei n 1.4 1.4
Trig Iyce rid es 1.3 10.5
Uric acid 1.6 4.3
Urea 3.3 6.2
C3 4.4 2.6
C4 <0.1 4.5
CRP 2.4 26~3
HbA,< 2.4 1.0
IgA 2.3 25
IgG 43 2 .. 3
IgM 2.5 3.0
RF 1.9 4.3 Stojanovic et al.: Evaluation 01 the Konelab 20XT clinical chemistry analyzer 549

Table 4 Accuracy of the Konelab 20XT clinical chemistry analyzer and quality specification for inaccuracy (5, 61.
Anatvte Unit Target Konelab 20XT Konelab 20XT Ouaritv
value result bias vs. control specificau 0 n.
materi a l, % %
Chloride mmol/L 91.3 90.5 0.9 0.5
Potassium mmol/L 3,86 3.76 2.6 1.8
Sodium mmol/L 138 1393 0.9 0.3
ALP U/L 95.3 96.4 12 6.4
ALT U/L 39.3 39.5 0.5 12.0
AMY U/L 83.6 81.5 2.3 7.8
AST U/L 37 36 2.7 5.4
Calcium rnrnol/L 2.32 2.32 0 0.8
Cholesterol mmolfL 2.44 2.41 1.64 4.0
csu I-lmoi/L 13.8 13 5.8 14.2
CK U/L 175 171 2.4 11.5
Creatinine )-lmol/L 108 109.2 1.11 3.4
GGT U/L 44.7 44.9 0.45 108
GLC mmollL 5.52 5.57 0.91 2.2
LOH U/L 316 315.6 0.06 4.3
MagnesilJm mmollL 1.02 1.03 0.98 1.8
Phosphorus mmoi/L 1.24 1.23 0 3.2
Total bilirubin )-lmol/L 18.3 18.5 1.1 10.0
Total protein giL 50.8 49.7 2.2 1.2
Triglycerides mmol/L 1.40 1.44 2.9 10.7
Urea mmol/L 6.91 7.06 2.2 4.8
Uric acid I-lmollL 252 252.7 0.3 5.5
C3 giL 1.07 1.1 2.8 4.1
C4 gIL 0.2 0.21 5 8.6
CRP mg/L 30 28 5.7 24.9
HbA" % 6.45 6.26 3.0 1.1
IgA gIL 1.68 1.75 4.2 9.1
IgG giL 9.0 929 3.2 4.3
IgM giL 0.76 0.75 1.3 11.9
RF U/mL 42-58 49 6.5 phosphorus, total protein, triglycerides and uric acid, and within the range 1.9-4.5% for the remaining anaIytes at all levels studied. The occasional inversion observed for within-run and between-day CV values might be due to drift effects. Another possible explanation for the unusual imprecision study results is that the within-run imprecision estimated according [0 the recommendations may not represent the typical true within-run imprecision, because the instruments and reagents may perform significantly better or worse on a given day. In addition, the reliability of the between-day estimates is highly dependent on the number of days and runs per day over which the study is carried out (13). However, all the CV% values obtained were very low, so it might be assumed that they have no clinical significance. The data obtained from the between-day imprecision study were considered representative of the Konelab 20XT performance characteristics and were compared with recently published quality specifications (5, 6). All analytes met the

Table 5 The observed upper limit of the anatvticat range of selected analvtes tested on the Konelab 20XT analyzer.

Analvta Unit Claimed Observed
ALT U/L 450 853
AMY U/L 2000 3200
CK U/L 1000 3500
GGT U/L 450 1200
T riglycerides mmol/L 10 15.92 desirable quality specifications for imprecision except calcium, creatinine, C3, HbA,c' IgG and Na " (Table 3).


In general, the inaccuracy of all measurements was acceptable according to established criteria (Table 4l. The results obtained met the quality specifications for inaccuracy of analytical systems, although discr epancies were found for the measurements of K', CI , Na ". HbA,c and total protein concentrations. The bias observed was so low that it is conceivable that it would not influence the decision-making process under any circumstances.


Statistically significant reagent-related carry-over effects were not found. The mean valu e of the carryover ratio (K) for AST was 057%, which is lower than double value of CV for within-run imprecision used as a criterion for assessing sample-related carry-over. Thus, no significant sample-related carry-over effects were found either.


It was demonstrated that the analytical system operates within the claimed linearity limits, considering deviations greater than 5% from the target value as an index of non-linear behavior. The linearity for the

650 Stojanovic at al.: Evaluation of the Konelab 20XT clmical chemistry analyzer

Table 6 Comparison of the Konelab 20XT with the Olympus AUnOO and Behring Nephelometer II (immunoglobulins).

Analvte Range Intercept 95% CI Slope 95% CI P
Chloride. mmol/l 93-112 6.000 - 16.50 to 6.0 1.000 1.00-1.22 0.936 < 0.0001
Potassium. mmol/L 3.2-54 0.100 0.10 to 0.10 1.000 1.00-1.00 0.987 <0.0001
Sodium. mmol/L 130-151 7.000 -39.0 to 8.0 1.000 1.00-1.33 0.847 < 0.0001
ALP. U/l 19-682 11.000 8.10 to 13.58 1,000 0.97-1.03 0.992 <0.0001
Al T. U/L 7-232 3000 3.00 to 3.77 1.000 0,97-1.00 0,996 < 0.0001
AMY. U/l 20-367 0.633 0,00 to 1.79 0,884 0,97 -1,00 0.997 < 0,0001
AST. U/l 9-125 3.734 1.81 to 4.00 1.016 1.00-1.10 0.978 < 0.0001
Calcium. mmol/l 0,95-3.15 -0.054 - 0,23 to 0.07 1039 0.99-1.11 0.964 <0.0001
Cholesterol. mmol/L 2.1-8.8 0.200 0.20 to 0.38 1.000 0.96-1.00 0994 <0.0001
CK. U/L 8-4080 2.099 1.37 to 3,00 1.015 1,00-1,03 0.999 < 0.0001
Creatinine. urnol/t, 51-1354 1,752 0.22 to 2.96 1,068 1.06-1.08 0,999 <0.0001
cau. u mol/l, 0-23 2.900 080 to 4.33 1.200 1.08-1.40 0,987 0( 0.0001
GGT. U/L 7-467 2.653 2.13 to 3.21 0,941 0.92-0.95 0.999 <0.0001
GLC. mrnol/t, 2.8-11 - 0.147 -0,39 to 010 1.053 1.00-1,10 0,993 < 0.0001
lDH. U/l 215-963 - 13.291 - 27.04 to 1,07 1.038 0.99-1.07 0.999 <0.0001
Magnesium. mmolll 0.6-1.21 0.140 0.04 to 0.20 1000 0.93-1 13 0898 < 0.0001
Phosphorus. mmol/L 0.62-2.22 -0.Q15 - 0,03 to 0.01 1.059 1.03-1.08 0.993 <0,0001
Tora! bilirubin. )J.mol/L 6-46 -0.270 - 0.79 to 0.23 0,975 0.93-1.01 0.981 < 0.0001
Total protein. giL 53-83 -2.000 -8.33 to 3.00 1.077 1,00-1.17 0,950 < 0.0001
Triglycerides. mmollL 0.63-6.04 -0,032 - 0.06 to - 0.01 1.114 1.10-1,13 0.999 <0.0001
Urea. mmol/L 0.3-43.8 0.788 051 to 0,99 1.039 1.01-1.07 0996 < 0.0001
Uric acid. u mol/l, 80-582 15.066 9.77 to 23.00 0,887 0.96-1,01 0.989 <0.0001
C3. gil 0,64-1.81 -0.051 -0,19 to 0,05 1.188 1,09-1.30 0.964 < 0.0001
C4. giL 0.09-0.54 -0.083 -0.11 to -0.04 1.571 1.42-167 0.919 < 0,000 1
CRP. mg/L 2-264 0246 -2.08 to 1,77 1,159 1.06-1.26 0.986 0( 0.0001
HbA,<.% 4,7-12 -1.352 - 2,87 to 035 1.293 1.00-1.52 0,978 <00001
IgA. gil 0.27-14.4 0,004 -0.18 to 0.15 1.264 1.18-1,36 0.985 < 0.0001
IgG. giL 2.2-29.2 - 2.385 -5.38 to -0.82 1.513 1.33-1.72 0.965 <0,0001
IgM. giL 0.24-2.62 -0,092 -0.15 to -0.03 1301 123-138 0.981 < 0.0001
RF. U/mL 22-475 0.196 -14,00 to 13,00 0.609 0.25-1.00 0.986 <0.0001 ALT. AMY. CK. GGT and triglyceride assays was greater than the range specified by the manufacturer. It was observed that the upper linearity limits were above the values specified by the manufacturer (Table 5).

Comparison with routine instruments

The results obtained using the Konelab 20XT analyzer carrel ated well (r ~ 0.95) with those from the analyzers routinely used in our laboratory (Olympus AU2700, aN II) except for CI- (r=0.94). Na' (r=0.85), magnesium (r=0.90) and C4 (r=092) (2. 14), The intercept (A) and slope (8) were calculated with the 95% confidence interval. which was used to test th e hypotheses that A = 0 and a = 1 (Table 6). The hypothesis was accepted if the confidence interval for A contained the value 0 and if the confidence interval for S contained the val ue 1. Th e slope was beyond this acceptance criterion for creatinine. conjugated bilirubin (CSILl. GGT. inorganic phosphorus. triglycerides. urea and the specific proteins (except HbA,c and RF) suggesting the existence of at least a proportional difference between the methods on the Konelab 20XT and on the routine instrum ents.

The intercept for magnesium. triglycerides. C4 and IgG was significantly different from a and it can be concluded that the methods employed by the Konelab 20XT differ from the methods on the comparison instrument at least by a constant amount. Slight differences were observed in the intercepts for CI-. ALP. ALT. AST. urea and IgM. The comparison results for

the other analvtes showed no significant difference in the intercept (an intercept less than 5% of the upper lim it of the reference interval was considered acceptable) (2).


Bilirubin caused negative interference (~15%) in the measurement of cholesterol. creatinine. GLC. and inorganic phosphorus at a concentration of 200 fLmol/L or above. while measurement of creatinine and triglyceri des was affected by a bili ru bin concentration of 100 u.rnol/l.. Figure lA.S shows the analytical interference of bilirubin on the analvtes measured.

Slight hemolysis (Hb concentration of 1 giL). as expected. significantly interfered with the AL T, AST. CSll. LDH and total bilirubin assays, leading to significant overestimation of these analytes (> 30%1. and underestimation of inorganic phosphorus. ALP and GGT (>20%) (Figure lC-FI. Hemoglobin at a concentration of approximately 2,5 giL (mild hemolysis) caused positive interference with the K + and magnesium measurements and negative interference with the AMY measurements, The RF assay was also affected by mild hemolysis. resulting in a strong decrease in RF values 00%). Hemoglobin at concentrations higher than 5 giL caused positive interference with CK. total protein. cholesterol. GLC and uric acid measurements. while CRP was affected negatively by such a strong hemolysis,

Stoianovic et al.: Evaluation of the Konetab 20XT clinical chemistry analyzer 651



~ 150


i/. 150




2' 100 ~






E O~-L~--~~~ -L~ __ ~~~

:::. 0 100 200 300 400 500 600 700 600 900 1 000 11 00

C bilirubin. IJ.M

bilirubin, ~


(/. 700 8' 1>00 ';(

.,. 500

~ 400 e

m 300

,6, 200 'C

.!! 100 'iii

C O~~~ __ ~~~~~~-L~ __ ~

E- 0 2 3 4 5 6 7 B 9 10

hemoglobin, giL

i/. 150
:? 100
c 50
c 0
E- O 2 3 4 5 6 7 8 9 10
hemoglobin, gil
.; 200
e 100 .Mg
.. ",p
0. 50 ,. TPAOT
'i: OUR AC
.. 00
oS 2 3 4 5 6 7 8 9 10
:::. hemoglobin, giL
.,. 200
e 150
" 50 0
c 1 2 3 4 5 6 7 B 9 10
E- IntrallpldH', giL F
15- 140
';( 120
2' 1
., 80
'i 60
c 40
g 20
to 0
C 0 1 2 3 4 5 6 7 8 9 10
E- hemoglobin, giL H

"'_ 220 8


.,. 140 8120

!. 1 00 4::::~~r.Q-.D---o-.o---a-"""---'5 80 , 60

i/. 140
8' 120 .,
C 100
:; BO
~ 60
c 40
g 20
E. ;;; 40
f 20
.. 0
oS 0
:::. 3 4 5 6 7 B 9 10 Intl'llllpldH', BlL


(/. 2000


'j; 1500
., 1000
a, 500
s 1 2 3 • 5 6 7 B 9 10 IntrallpldTl., gil

~ ~

'" CK




Figure 1 The effect of hyperbilirubinemia, hemolysis and lipemia on the measurement results: IA. BI interlerence ot bilirubin; IC-FI interierence of hemoglobin; and (G-K) interference of lntr alipid " 20%, CHOL, cholesterol; CREAT. cr e atiruna: Tg, trrglyceride; UR AC, uric acid; T81l, total bilirubin; TPROT, total protein.


652 Stcjanovic et al.: Evaluation of the Konelab 20XT clinical chemistry analyzer

lntralipid '" 20% at a concentration of 1 gIL caused sample turbidity, resulting in overestimation of CBll, total bilirubin, inorganic phosphorus and magnesium, and underestimation of RF, CRP, HbA,c and creatinine IFigure 1 G-K), lntralipid ,. 20% at a concentration of 2 gIL led to increased values of GlC and strongly decreased Al T values. The influence of turbidity due to 3 gIL lntralipid " 20% was observed in the AST and total protein assays, There was negative interference by Intralipid ,. 20% at concentrations above 4 gIL in the C4 and IgM assays.


The Konelab 20XT is an easy-to-use clinical chemistry analyzer with simple maintenance. Our investigation of the analytical performance of the Konelab 20XT, carried out according to the ECClS guidelines (1), showed that imprecision was low and that the total imprecision for a large number of analvtes met the quality specifications required, The accuracy of the a nalytical system was also satisfactory, except for the measurement of electrolytes, HbA,c and total protein. The results that were outside the desirable qual ity specifications were still within clinically acceptable limits. Th e I inearity range for the analytes tested was wide, which reduces the need for manual dilution, The stability of the calibration curves 114-20 days) for the substrates and most of the specific proteins (C4, IgA, IgM, RF, HbAtc) spares calibrators and reduces consumption of reagents. The analyzer consumes less than 1 L of distilled water/h, which eliminates the need for a continuous external water supply. The throughput observed was approximately 200 tests/h with out the specific proteins, which was different from the value stated by the manufacturer. In addition, the dead volume is stated to be 50 f.LL, but we observed that the minimum sample volume required for ISE measurements is 200 u.L, and 100 f.LL for the CRP assay. No significant sample- or reagent-related carry-over was found,

The lack of concordance between the results for measurement of specific proteins on the other instruments can be explained by the different analytical principle in the measurement of immunoglobulins (immunoturbidimetry vs. laser nephelometry) and by the different composition of the reagents and calibrators used for the determination of C3, C4 and CRP, Because the same lot of the Olympus System Calibrator was used for calibration of the Konelab 20XT and Olympus AU2700, the slope differences observed for the m easu rement of inorgan ic phosphorus, triglycerides and u rea could be due to small differences in reagent composition, and to the instability observed for the reagents for urea and creatinine (calibration needed on a daily basis) A slight difference in the intercept for CI- can be explained by the different analytical principle used in the comparison instrument (direct vs. indirect potentiornetrvl, whil e th e lack of agreement between results obtained for the AST and ALT measurements was probably due to non-lin-

ear measurement at low enzyme activities « 20 U/LJIn addition, the reagents for AST and AL T determination manufactured by Olympus Diagnostica contain pyridoxal phosphate, which is not the case with the Thermo Electron reagents

Data on interferences by bilirubin are in accordance with known facts or statements issued by the man ufacturer (2, 11), Slight hem olysis significantly i nterfered with magnesium and bilirubin measurements, as expected. but interierence that occurred even at a hemoglobin concentration of 1 gIL in the determination of ALP is relevant. Sample tu rbidity significantly interfered with magnesium, inorganic phosphorus and CRP measurements. The manufacturer recommends that lipemic sera should not be used for CRP measurements, and the results obtained confirm the necessity for delipidation prior to CRP measurement. The results for bilirubin, GlC, HbA,c and RF were highly affected by very low sample turbidity {the concentration of Intralipid ,. 20% was 1-2 gill, A strong effect of lipemia on creatinine measurement results was observed. In addition, lipemia exerted a significant influence on the precision of creatinine measurement. While not surprising for immunoturbidimetric measurements, interference by mild lipemia in the GLC assay was unexpected and cannot be explained by the method applied.

In conclusion, the Konelab 20XT clinical chemistry analyzer is robust, easy to operate and suitable lor use in small laboratories. Low maintenance requirements and no need for an external water supply facilitate its implementation in various environments,

A ck n owl ed ge m ents

We thank Mrs. Mirjana Fucek for performing analyses on {he Olympus AU2700, and Thermo Electron Ov (Finlandl for providing the reagents used in the evaluation.


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Received Februa ry 2, 2005, accepted April 4, 2005

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