ALBUMIN

OSR6102 4 x 29 mL R1
OSR6202 4 x 54 mL R1

Intended Use
Photometric colour test for the quantitative determination of albumin in human serum and plasma on Beckman Coulter analysers. For in vitro diagnostic
use only.

Summary1,2
Albumin is the most abundant protein in human plasma, representing 55-65% of the total protein. Its primary biological functions are to transport and store
a wide variety of ligands, to maintain the plasma oncotic pressure and to serve as a source of endogenous amino acids. Albumin binds and solubilises
non-polar compounds such as plasma bilirubin and long-chain fatty acids as well as binding numerous pharmaceuticals.
Hyperalbuminemia is infrequent and is caused by severe dehydration and excessive venous stasis. Hypoalbuminemia may be caused by impaired
synthesis e.g. in liver disease or in protein deficient diets; increased catabolism as a result of tissue damage and inflammation; reduced absorption of
amino acids caused by malabsorption syndromes or malnutrition; protein loss to the exterior as observed in nephrotic syndrome, enteropathy or burns; and
altered distribution e.g. in ascites. Severe hypoalbuminemia results in a serious imbalance of intravascular oncotic pressure causing the development of
edema.
Measurements of albumin concentrations are vital to the understanding and interpretation of calcium and magnesium levels because these ions are bound
to albumin, and so decreases of albumin are also directly responsible for depression of their concentrations.

Test Principle3
A coloured complex is formed when bromocresol green reacts with albumin. The absorbance of the albumin-BCG complex is measured bichromatically
(600/800nm) and is proportional to the albumin concentration in the sample.

Reaction Principle
pH 4.2
Albumin + Bromocresol Green Green Complex

Contents, Reagent Composition in the Test

Final concentration of reactive ingredients:
Succinate buffer (pH 4.2) 100 mmol/L
Bromocresol green 0.2 mmol/L
Preservative

Precautions and Warnings

Hazard Warnings and Risk Phrases:
R1: Irritant, contains a mixture of 5-chloro-2-methyl-4-isothiazolin-3-one [EC No 247-500-7] and 2-methyl-4-isothiazolin-3-one
[EC No 220-239-6] (3:1). R43: May cause sensitisation by skin contact.
Safety Phrases:
S24, S37, S60. Avoid contact with skin. Wear suitable gloves. This material and its container must be disposed of as hazardous waste.
Dispose of all waste material in accordance with local guidelines.
Refer to Safety Data Sheets for further information.

Reagent Preparation
The reagent is ready for use and can be placed directly on board the instrument.

Storage and Stability

The reagent is stable, unopened, up to the stated expiry date when stored at 2…25°C. Once open, reagent stored on board the instrument is stable for
90 days.

Specimen
Serum and EDTA or heparinised plasma.
4
Separate from cells immediately. Separated plasma and serum is stable at 2…8°C for 30 days and at 15…25°C for 7 days.

Test Procedure
Refer to the appropriate User Guide and Setting Sheet for analyser-specific assay instructions for the sample type as listed in the Intended Use statement.
The paediatric application is suitable for use with small volume serum/plasma samples.

Calibration
System Calibrator Cat. No. 66300.
The calibrator albumin value is traceable to IFCC (International Federation of Clinical Chemistry) standard CRM 470. Recalibrate the assay when the
following occur:
Change in reagent lot number or significant shift in control values;
Major preventative maintenance was performed on the analyser or a critical part was replaced.

Quality Control
Controls Cat. No. ODC0003 and ODC0004 or other control materials with values determined by this Beckman Coulter system may be used.
Each laboratory should establish its own control frequency however good laboratory practice suggests that controls be tested each day patient samples
are tested and each time calibration/blanking is performed.
The results obtained by any individual laboratory may vary from the given mean value. It is therefore recommended that each laboratory generates analyte
specific control target values and intervals based on multiple runs according to their requirements. These target values should fall within the corresponding
acceptable ranges given in the relevant product literature.
If any trends or sudden shifts in values are detected, review all operating parameters.
Each laboratory should establish guidelines for corrective action to be taken if controls do not recover within the specified limits.

EN.01 BLOSR6x02.01 Metabolite

2009-08
Calculation
The Beckman Coulter analysers automatically compute the albumin concentration of each sample.

Reference Intervals5,6
Serum (Adults) 35 – 52 g/L (3.5 – 5.2 g/dL)
Serum (Newborn 0 – 4 day) 28 – 44 g/L (2.8 – 4.4 g/dL)
Expected values may vary with age, sex, sample type, diet and geographical location. Each laboratory should verify the transferability of the expected
values to its own population, and if necessary determine its own reference interval according to good laboratory practice. For diagnostic purposes, results
should always be assessed in conjunction with the patient's medical history, clinical examinations and other findings.

Specific performance characteristics

Data contained within this section is representative of performance on Beckman Coulter systems. Data obtained in your laboratory may differ from these
values.
Linearity
The test is linear within a concentration range of 15 – 60 g/L (1.5 – 6.0 g/dL)
Precision
The following data was obtained on an AU600 using 3 serum pools analysed over 10 days.
n = 60 Within Run Total
Mean g/L SD CV% SD CV%
24.04 0.43 1.80 0.63 2.62
42.93 0.50 1.17 0.67 1.55
57.77 0.53 0.92 1.03 1.79
Sensitivity
The lowest detectable level in serum on an AU600 analyser was estimated at 0.07 g/L.
The lowest detectable level represents the lowest measurable level of albumin that can be distinguished from zero. It is calculated as the absolute mean
plus three standard deviations of 20 replicates of an analyte free sample.
Method Comparison
Patient serum samples were used to compare this Albumin OSR6102 assay on the AU600 against another commercially available albumin assay. Results
of linear regression analysis were as follows:
y = 0.982x – 3.860 r = 0.994 n = 121 Sample range = 11.70 – 50.85 g/L

Interfering Substances
Results of studies conducted to evaluate the susceptibility of the method to interference were as follows:
Icterus: Interference less than 10% up to 40 mg/dL or 684 µmol/L bilirubin
Haemolysis: Interference less than 10% up to 4.5 g/L haemoglobin
®
Lipemia: Interference less than 10% up to 800 mg/dL Intralipid
In very rare cases gammopathy, especially monoclonal IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
7
Refer to Young for further information on interfering substances.

Setting Sheet Footnotes

# User defined ¤ Analyser default value
† System Calibrator Cat. No.: 66300
* Values set for working in SI units (g/L). To work in g/dL divide by 10.

BIBLIOGRAPHY
1. Grant GH, Silverman LM, Christenson RH. Amino acids and proteins. In: Tietz NW, ed. Fundamentals of clinical chemistry. Philadelphia:WB Saunders Company,
1987:328-329.
2. McPherson RA. Specific proteins. In: Henry JB, ed. Clinical diagnosis and management by laboratory methods. Philadelphia:WB Saunders Company, 1996:244-
245.
3. Doumas BT, Watson WA, Biggs HG. Albumin standards and the measurement of serum albumin with bromcresol green. Clin Chim Acta 1971;31:87-96.
4. Young DS, ed. Effects of preanalytical variables on clinical laboratory tests, 2nd ed. Washington:AACC Press, 1997:3-15-3-16.
5. Baudner S, Dati F. Standardization of the measurement of 14 proteins in human serum based on the new IFCC/BCR/CAP international reference material CRM
470. J Lab Med 1996;20:145-152.
6. Painter PC, Cope JY, Smith JL. Reference information for the clinical laboratory. In: Burtis CA, Ashwood ER, eds. Tietz textbook of clinical chemistry.
Philadelphia:WB Saunders Company, 1999; 1800pp.
7. Young DS. Effects of drugs on clinical laboratory tests, 5th ed. AACC Press, 2000.

Metabolite BLOSR6x02.01 EN.01

2009-08