2 Albumin

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ALBUMIN

Colorimetric method (BCG) for the quantitative


determination of Albumin in serum and plasma

ORDER INFORMATION INTERNAL QUALITY CONTROL


REF Kit size It is recommended to use commercial Quality Control sera
GA4201 00 10x50 ml with known Albumin concentration to check the
KL2012 00 8x20 ml correspondence of the obtained results with those expected
BK2012 00 2x60 ml and validate the data.

INDICATION ANALYTICAL PROCEDURE


Albumin concentration is an index of liver synthetic activity. Allow the reagents to reach working temperature before
While its increase is typically caused by a using.
hemoconcentration (in vivo for dehydration, in vitro for
sample evaporation or protracted stasis by tourniquet), Pipette into disposable or well clean cuvettes :
causes of hypoalbuminemia are numerous: proteins loss Blank Standard Sample
(nephritic syndrome, burn, proteins-dispersing Reagent A 1000 l 1000 l 1000 l
enteropathy), increased turnover (catabolic state, Standard - 5 µl -
glycocorticoids), decreased protein uptake (malnutrition, Sample - - 5 µl
low protein diets) and, liver disease. In particular, in
Mix and incubate for 5 minutes at room temperature
chronic hepatitis its decrease is proportional to the
(20-25 °C). Read the absorbance (A) of the standard and
progression to cirrhosis, representing a maker of prognosis
samples at 546 (520-570) nm against blank.
and metabolic decompensation.
Colour is stable for 60 minutes.
Plasmatic concentration is lower in newborn (2.4-4.4 g/dl).
Within the first week values of the adults are reached (3.5–
5 g/dl); then its production increases up to 4.5–5.4 g/dl at Note:
an age of six years and remains unchanged during Reaction volumes can be proportionally modified.
adolescence. No significant difference is found among male
and female. CALCULATION OF RESULTS

METHOD PRINCIPLE Utilize the following formula:


In citrate buffer albumin forms with green bromocresol
(BCG) a coloured compound with a colour intensity A sample
Albumin, g/dl = x4
proportional to the albumin concentration present in the A standard
sample.
Values in g/dl can be modified to obtain g/l multiplying the
COMPOSITION results x 10.
REAGENT A (liquid):
Citrate buffer 7.5 mmol/l REFERENCE VALUES
BCG ≥ 150 mol/l
Sodium azide 0.05% 3.5 ÷ 5 g/dl

STANDARD (liquid): 1x4 ml Each laboratory should establish reference ranges for its
Albumin 4 g/dl own patients population.
Sodium azide 0.05%
Verified against NIST reference standard. ANALYTICAL PERFORMANCES
Precision
Storage and stability Within-run and between-run coefficients of variation have
Store at 15-25 °C. been calculated on replicates of three samples at different
Reagents are stable until the expiry date stated on the Albumin concentrations. The obtained results are reported
labels, if contamination and evaporation are avoided, in the following table:
protected from light. The above conditions are valid if the
vials are opened just only for the time to take the reagent, Within Run Between Run
closed immediately with their cap and stored at the Mean
indicated conservation temperature. Sample SD %CV SD %CV
(g/dl)
Serum 1 4.6 0.03 0.7 0.14 3.0
ANCILLARY EQUIPMENT
Serum 2 4.0 0.02 0.5 0.14 3.5
 Automatic pipettes
 Photometer Serum 3 3.3 0.02 0.6 0.10 3.0
 Analysis cuvettes (optical path = 1 cm)
 NaCl solution 9 g/l Linearity
The assay is linear up to 7 g/dl.
SAMPLES
Serum or plasma (heparin or EDTA). Sensitivity
Stable one month at 2-8 °C, or one week at 15-25 °C. Test sensitivity of the method, in terms of limit of detection,
is 0.2 g/dl.
Specimen collection / Preanalytical factors
It is recommended that specimen collection should be Correlation
carried out in accordance with NCCLS Document H11-A3. A correlation study comparing the present method with a
commercial one gave the following results:

y = 0.624x + 1.616 g/dl r = 0.9691

Pag. 1/2
GA4201 00 – KL2012 00 – BK2012 00 ALBUMIN

Interferences
In case of clear haemolysis or lipemia it is recommended
the execution of a blank sample: mix 1 ml of physiological
and 10 l of sample, read absorbance against distilled water
and subtract it to the absorbance value measured in the
test.
Hemoglobin up to 20 mg/dl doesn’t interfere.

PRECAUTIONS IN USE
The Reagent A (REF GB201200) is harmful (Warning -
GHS07: H315, H319).
Skin Irrit. 2, Eye Irrit. 2
Hazard statement Codes: H315 - Causes skin irritation;
H319 - Causes serious eye irritation.
Precautionary statements:
Prevention P280 - Wear protective gloves/protective
clothing/eye protection/face protection.
Response P337+P313 - If eye irritation persists: Get
medical advice/attention.
The Standard (REF GB308100) is not considered
harmful (GHS00) according to (CE) n. 1272/2008
directive about classification, packaging and labelling of
dangerous substances.
However, the reagents should be handled with caution,
avoiding swallowing and contact with skin, eyes and
mucous membranes.
The use of laboratory reagents according to good laboratory
practice is recommended.

Waste Management
Please refer to local legal requirements.

REFERENCES

1. PANTEGHINI M., “Interpretazione degli esami di


laoratorio” pp. 179-180 Piccin (2008)
2. RODKEY F.L., Clin. Chem. 10:606 (1964)
3. DUMAS B.T., et al., Chim. Clin. Acta 31:87 (1971)
4. NCCLS Document, “Procedures for the collection of
arterial blood specimens”, Appr. Std., 3rd Ed. (1999).
5. EU-Dir 1999/11 Commission Directive of 8 March 1999
adapting to technical progress the principles of good
laboratory practice as specified in Council Directive
87/18/EEC.

NOTE: Changes Highlighted

Pag. 2/2
AMS Srl. – Registered Office and Plant
Via E. Barsanti 17/A
00012 Guidonia (Rome) – Italy
Ph. + 39 0774 354441 Met. GA420100.3 eng
Fax + 39 0774 578035 Edition: 2018-11
www.amsalliance.com - info.it@amsalliance.com

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