EVALUATION OF ERYTROPOIETIN ASSAY IN SERUM ON THE IMMULITE 1000 ANALYSER

1. 2011 Poster 13
Biochimie
Biochemistry
EVALUATION OF ERYTROPOIETIN
ASSAY IN SERUM ON THE IMMULITE
1000 ANALYSER
Jozo Čorić1, R. Javoric1, E. Kucukalic1
1 - Department of Clinical Biochemistry, Clinical Centre University of
Sarajevo - Sarajevo, Bosnia and Herzegovina

2. 2011 Poster 2
INTRODUCTION Biochimie
Biochemistry
ERYTHROPOIETIN (EPO) IS A HORMONE THAT IS BY ITS
CHEMICAL STRUCTURE OF THE GLYCOPROTEIN.
THIS HORMONE IS SECRETED FROM THE KIDNEYS. IT IS THE
PRIMARY REGULATOR OF ERYTHROPOIESIS, THE PROCESS OF
PROLIFERATION AND DIFFERENTIATION OF ERYTHROCYTIC
LINEAGE CELLS IN BONE MARROW.
UNCONTROLLED SECRETION OF ERYTHROPOIETIN CAN LEAD
TO ANEMIA OR POLYCYTHEMIA. THE CLINICAL SIGNIFICANCE
OF ERYTHROPOIETIN DETERMINATION IS REFLECTED IN THE
PREVENTION AND EARLY DIAGNOSIS OF DISEASES
OF HEMOSTASIS.

3. 2011 Poster 3
Biochimie
MATERIALS AND METHODS Biochemistry
IMMULITE ERYTROPOIETIN IS A SOLID-PHASE, ENZYME-LABELED
CHEMILUMINESCENT IMMUNOMETRIC ASSAY. THE SOLID PHASE
(BEAD) IS COATED WITH ANTI-LIGAND DERIVED FROM
STREPTAVIDIN. THE LIQUID PHASE CONSISTS OF LIGAND –
LABELED MONOCLONAL MURINE ANTI-EPO ANTIBODY AND
ALKALINE PHOSPHATASE (BOVINE CALF INTESTINE)
CONJUGATED TO MONOCLONAL MURINE ANTI-EPO ANTIBODY.

4. 2011 Poster 4
Biochimie
MATERIALS AND METHODS Biochemistry
ANALYTICAL VALIDATION OF ERYTROPOIETIN DETERMINATION
BY CHEMILUMINESCENT IMMUNASSAY ON IMMULITE 1000
SYSTEM INCLUDED: WITHIN-RUN IMPRECISION ON THE
COMMERCIALLY CONTROLS (N=20); BETWEEN-DAY
IMPRECISIONON COMMERCIALLY CONTROLS (N=25); INACCUACY
ON COMMERCIALY CONTROLS (N=15) AND COMPARATION
DETERMINATION ON THE HUMAN SEMPLES (N=20) ON 2 SYSTEMS:
IMMULITE 2000 AND IMMULITE 1000 ANALYSERS.

5. 2011 Poster 5
Biochimie
RESULTS Biochemistry
THE RESULTS OF THE IMMULITE 1000 ASSAY PRECISION WITHIN-
RUN AND BETWEEN-RUN ANALYSES ARE SHOWED IN TABLE I.
THE COEFFICIENT OF VARIATION (CV%) VALUES FOR WITHIN-
RUN PRECISION WERE 3,6-4,0 %, WITH THOSE FOR THE
BETWEEN-RUN RANGING 5,9-6,5 %. THE RESULTS VARIATION
WAS GREATER AT LOWER CONCENTRATIONS.

6. 2011 Poster 6
Biochimie
RESULTS Biochemistry
TABLE I PRECISION OF ERYTROPOIETIN ASSAY ON THE IMMULITE
1000 ASSAY
MEAN VALUE
SUMPLE Sd
SAMPLE
NUMBER (n)
ERYTROPOETIN CV (%)
(mIU/ml) (mIU/ml)
WITHIN RUN
CONTROL L1 20 10,3 0,41 4,0
CONTROL L2 20 43,5 1,56 3,6
CONTROL L3 20 132,8 4,78 3,6
BETWEEN RUN
CONTROL L1 25 10,4 0,67 6,5
CONTROL L2 25 42,3 2,65 6,2
CONTROL L3 25 135,8 8,0 5,9

7. 2011 Poster 7
Biochimie
RESULTS Biochemistry
METHOD COMPARASION ON HUMAN SAMPLES SHOW IN THE
RANGE OF METHOD LINEARITY CORRELATION COEFFICIENT
FROM 0,97 (FIGURE 1).
FIGURE 1 CORRELATION BETWEEN THE RESULTS OF
ERYTROPOETIN ASSAY USING IMMULITE 2000 AND IMMULITE 1000
ANALYSERS
EPO Immulite 2000 (mIU/ml)
100,0
80,0
r = 0,97
60,0 y= 0,95x + 076
40,0
20,0
0,0
20,0 40,0 60,0 80,0 100,0
EPO Immulite 1000 (mIU/ml)

8. 2011 Poster 8
Biochimie
DISCUSSION Biochemistry
IMMULITE 1000 SHOWED GOOD PRECISION. THE OBTAINED CV %
FOR THE WITHIN-RUN PRECISION WERE 3,6-4,0 %, WHICH WAS IN
ACCORDANCE WITH THE MANUFACTURER‛S RECOMMENDATION.
HOWEVER, CV% VALUES FOR THE BETWEEN-RUN PRECISION (5,9-
6,5%) SLIGHTY EXCEDED THE MANUFACTURER‛S
RECOMMENDATIONS. THE CORRELATION BETWEEN THESE TWO
ASSAYS WAS SIGNIFICANT (y=0,95x+0,76; r=0,97). DETERMINATION
ERYTROPOIETIN IN SERUM ON THE IMMULITE 1000 ANALYSER
DEMONSTRATES ADEQUATE PERFORMANCE CHARACTERISTIES
FOR ROUTINE CLINICAL USE.

9. 2011 Poster 10
Biochimie
CONCLUSION Biochemistry
THE PRESENTED RESULTS OF THE ANLYTICAL EVALUATION
METHODS FOR THE DETERMINATION OF ERYTROPOIETIN ON
THE IMMULITE 1000 ANALYSER SHOWED AN ACCEPTABLE
ACCURACY AND PRECISION.