Principle of The Method Metrological Characteristics: Bromocresol Green

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ALBUMIN

COD 11547 COD 11573


2 x 250 mL 1 x 250 mL
STORE AT 2-8ºC
Reagents for measurement of albumin concentration ALBUMIN
Only for in vitro use in the clinical laboratory BROMOCRESOL GREEN

PRINCIPLE OF THE METHOD


METROLOGICAL CHARACTERISTICS
Albumin in the sample reacts with bromocresol green in acid medium forming a coloured
complex that can be measured by spectrophotometry 1.  Detection limit: 1.1 g/L.
 Linearity limit: 70 g/L.
CONTENTS
 Repeatibility (within run):
COD 11547 COD 11573
Mean Concentration CV n
A. Reagent 2 x 250 mL 1 x 250 mL
S. Standard 1 x 5 mL 1 x 5 mL 26.2 g/L 1.4 % 20
42.1 g/L 1.0 % 20
COMPOSITION
 Reproducibility (run to run):
A. Reagent: Acetate buffer 100 mmol/L, bromocresol green 0.27 mmol/L, detergent, pH 4.1.
Mean Concentration CV n
S. Albumin Standard: Bovine albumin. Concentration is given on the label. Concentration value
is traceable to the Standard Reference Material 927 (National Institute of Standards and 26.2 g/L 1.9 % 25
Technology, USA). 42.1 g/L 1.9 % 25

STORAGE  Trueness: Results obtained with this reagent did not show systematic differences when
compared with reference reagents (Note 3). Details of the comparison experiments are
Reagent (A): Store at 2-8ºC.
available on request.
Albumin Standard (S): Store at 2-8ºC, once opened.
 Interferences: Bilirubin (>10 mg/dL), lipemia (triglycerides >7.5 g/L) and hemoglobin (>2.5 g/L)
Reagent and Standard are stable until the expiry date shown on the label when stored tightly may affect the results. Other drugs and substances may interfere3.
closed and if contaminations are prevented during their use.
These metrological characteristics have been obtained using an analyzer. Results may vary if a
Indications of deterioration: different instrument or a manual procedure are used.
 Reagent: Presence of particulate material, turbidity, absorbance of the blank over 0.200 at
630 nm (1 cm cuvette). DIAGNOSTIC CHARACTERISTICS
 Standard: Presence of particulate material, turbidity. Albumin is the most abundant protein in human plasma. It has three main functions: it
contributes towards maintaining the colloid oncotic pressure of plasma, it acts as non-specific
REAGENT PREPARATION transport vehicle for many nonpolar compounds and it is a source of endogenous amino acids.
Reagent and Standard are provided ready to use. Hyperalbuminemia is of little diagnostic significance except in dehydration 2.
Hypoalbuminemia is found as a result of several factors: reduced synthesis caused by liver
ADDITIONAL EQUIPMENT diseases; reduced absorption of amino acids due to malabsorption syndromes or malnutrition;
 Analyzer, spectrophotometer or photometer able to read at 630 nm (610 - 670 nm). increased catabolism as a result of inflammation or tissue damage; altered distribution between
intravascular and extravascular space due to increased capillary permeability, overhydration or
SAMPLES ascites; abnormal losses caused by renal disease (nephrotic syndrome, diabetes mellitus,
chronic glomerulonephritis, systemic lupus erythematosus), gastrointestinal tract disease
Serum or plasma (EDTA, citrate or heparine) collected by standard procedures.
(ulcerative colitis, Crohn’s disease) or skin damage (exfoliative dermatitis, extensive burns);
Albumin in serum is stable for 3 days at 2-8ºC. congenital absence of albumin or analbuminemia 2,4.
PROCEDURE Albumin plasma concentrations, although important for management and follow-up, have very
little value in diagnosis2.
1. Pipette into labelled test tubes: (Notes 1, 2)
Clinical diagnosis should not be made on the findings of a single test result, but should integrate
Blank Standard Sample both clinical and laboratory data.
Albumin Standard (S)  10 µL  NOTES
Sample   10 µL
Reagent (A) 1.0 mL 1.0 mL 1.0 mL 1. This reagent may be used in several automated analysers. Instructions for many of them are
available on request.
2. Mix thoroughly and let stand the tubes for 1 minute at room temperature.
2. Albumin reaction with bromocresol green is immediate. It is not recommended to delay
3. Read the absorbance (A) of the Standard and the Sample at 630 nm against the Blank. The readings, since other proteins react slowly.
colour is stable for 30 minutes.
3. Calibration with the provided aqueous standard may cause a matrix related bias, specially in
CALCULATIONS some analyzers. In these cases, it is recommended to calibrate using a serum based
standard (Biochemistry Calibrator, cod. 18011 and 18044).
The albumin concentration in the sample is calculated using the following general formula:
BIBLIOGRAPHY
A Sample
 C Standard  C Sample 1. Doumas BT, Watson WA and Biggs HG. Albumin standards and the measurement of serum
A Standard albumin with bromocresol green. Clin Chim Acta 1971: 31: 87-96.

REFERENCE VALUES 2. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 4th ed. Burtis CA, Ashwood
Serum2: ER, Bruns DE. WB Saunders Co, 2005.
Newborn, 2 to 4 days 28-44 g/L 3. Young DS. Effects of drugs on clinical laboratory tests, 5th ed. AACC Press, 2000.
4 days to 14 years 38-54 g/L 4. Friedman and Young. Effects of disease on clinical laboratory tests, 4th ed. AACC Press,
Adult 35-50 g/L 2001.
> 60 years 34-48 g/L

These ranges are given for orientation only; each laboratory should establish its own reference
ranges.

QUALITY CONTROL
It is recommended to use the Biochemistry Control Serum level I (cod. 18005, 18009 and
18042) and II (cod. 18007, 18010 and 18043) to verify the performance of the measurement
procedure.
Each laboratory should establish its own internal Quality Control scheme and procedures for
corrective action if controls do not recover within the acceptable tolerances.

M11547i-20 BioSystems S.A. Costa Brava 30, Barcelona (Spain) 12/2008


Quality System certified according to
EN ISO 13485 and EN ISO 9001 standards

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