Albumin fluid Mono

Determination of Albumin in serum and plasma (Bromocresol green method)

REAGENT PACKAGE INFORMATION
Product FURUNO Configuration MEASUREMENT RANGE
Product No.
Name Analyzer R1 R2 0.15 – 8 g/dL in CA series
AF01917067-F5 5 x 67mL -
CA-270 CONVERSION FACTOR
AF01917067-F Albumin 10 x 67mL -
CA-400
AF01917067-F4 fluid Mono 4 x 20 mL g/dL g/L Factor: 10
CA-800
AF01917067-F16 16 x 20mL -
EXPECTED VALUES
INTENDED USE Reference: Tietz et. al.
In vitro test for the quantitative determination of Albumin in human serum and g/dL g/L
plasma. 0–4d 2.8 - 4.4 28 - 44
4d – 14y 3.8 - 5.4 38 - 54
SUMMARY 14 – 18y 3.2 - 4.5 32 - 45
Albumin is a carbohydrate-free protein, which constitutes 55-65% of total Adult (20-60y) 3.5 - 5.2 35 - 52
plasma protein. It maintains osmotic plasma pressure, is also involved in the 60 – 90y 3.2 - 4.6 32 - 46
transport and storage of a wide variety of ligands and is a source of >90y 2.9 - 4.5 29 - 45
endogenous amino acids. Albumin binds and solubilizes various compounds, e. Each laboratory should investigate the transferability of the expected values to
g. bilirubin, calcium and long chain fatty acids. Furthermore albumin is capable its own patient population and if necessary determine its own reference range.
of binding toxic heavy metals ions as well as numerous pharmaceuticals, which For diagnostic purposes the albumin results should always be assayed in
is the reason why lower albumin concentrations in blood have a significant conjunction with the patient's medical history, clinical examinations and other
effect on pharmacokinetics. Hyperalbuminemia is of little diagnostic findings.
significance except in the case of dehydration. Hypoalbuminemia occurs during
many illnesses and is caused by several factors: Compromised synthesis due
either to liver disease or as a consequence of reduced protein uptake, elevated
REPRODUCIBILITY
catabolism due to tissue damage (severe burns) or inflammation, Reproducibility in CA-800
malabsorption of amino acids (Crohn's disease), proteinuria as a consequence Within run (n= 20) Day-to-day run
of nephrotic syndrome; protein loss via the stool (neoplastic disease). In severe (Duplicate, 20days)
cases of hypoalbuminemia, the maximum albumin concentration of plasma is Mean SD Mean SD
2.5 g/dL. Due to the low osmotic pressure of the plasma water permeates CV% CV%
(g/dL) (g/dL) (g/dL) (g/dL)
through blood capillaries into tissue (edema). The determination of albumin Low 3.40 0.0310 0.91 3.33 0.0274 0.82
allows monitoring of a controlled patient dietary supplementation and serves High 4.65 0.0329 0.71 4.99 0.0561 1.12
also as an excellent test of liver function.
TEST COMPARISON
MEASUREMENT PRINCIPLE Comparison with a test of other manufacturer’s reagent of Albumin BCG
Albumin + BCG Albumin-BCG complex method in CA-800
The reaction between albumin in serum or EDTA plasma and the dye Y = 1.052 x + 0.1133, R = 0.996, N = 110
bromocresol green produces a change in color to blue-green. That is Comparison with a test of other manufacturer’s reagent of Albumin BCP
proportional to the albumin concentration. method in CA-800
Y = 0.995 x + 0.608, R = 0.989, N = 110
CONCENTRATION OF WORKING SOLUTION
Monoreagent QUALITY CONTROL
Succinate pH 4.2 75.00 mmol/L Multi QC sample “Centronorm” and ”Centropath” are used.
Bromocresol green 0.15 mmol/L
Product No. Product Name Configuration
Brij 35 Detergent 2 g/L
CNORM005 5 x 5 mL
CNORM010 Centronorm 10 x 5 mL
REAGENT PREPARATION, STORAGE AND STABILITY
CNORM020 20 x 5 mL
R1: Ready to use
The sealed reagents are stable up to the indicated expiry date if stored at +18° - CPATH005 5 x 5 mL
+22°C. Avoid direct sunlight. CPATH010 Centropath 10 x 5 mL
After opening the bottle, it is stable for 35 days when kept onboard in the CPATH020 20 x 5 mL
analyzer, if contamination is avoided. The control intervals and limit must be adapted to the individual laboratory and
country-specific requirements. Values obtained should fall within established
SAMPLE MATERIAL limits. Each laboratory should establish corrective measures to be taken if
Serum or EDTA/Heparin plasma. values fall outside the limits.
Separate serum or plasma from the clot or cells within
One hour and analyze immediately, or store as follows: CALIBRATION
< 3 days at +4°C Multi-calibrator ”Centrocal” is used.
6 months at -20°C S1: Saline, S2: Centrocal
Centrifuge samples containing precipitates before performing the assay. Recommended calibration interval: Weekly
Product No. Product Name Configuration
PRECAUTIONS AND WARNINGS CCAL005 5 x 3mL
For in vitro diagnostic use only. Attend to the normal precautions required for CCAL010 Centrocal 10 x 3mL
handling all laboratory reagents. CCAL020 20 x 3mL

INTERFERENCES
Free type of Bilirubin: No interference less than 20mg/dL LITERATURE
Conjugate type of Bilirubin: No interference less than 20mg/dL  Doumas, B. T. et al : Clin . Chim . Acta 31 , 87pp ( 1971 ); Weis, W.A..
Hemolytic hemoglobin: a little increase, 5% by 100mg/dL of Hb Klin.Wochenschr. 43, S.273 (1965)
Chyle: No interference less than 1800 FTU (*)  Carl A. Burtis, David E. Bruns: Tietz fundamentals of clinical chemistry and
*: FTU: Formazine turbidity unit molecular diagnostics, 7th ed.

TESTING PROCEDURE
Material provided
- Working solutions as described above
Additional materials required
- Calibrators and controls as indicated below
- “Saline Diluent” is used as diluent:
Product No. Product name Configuration
FSD917070 Saline Diluent 5 x 67mL

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Edition 06/2021, TV-003-CE-003FU
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