The Creative Approach to Bioscience

Albumin
210 001 100 test
210 002 300 test
210 003 600 test
210 004 800 test
211 001 200 test
211 002 400 test
211 003 500 test
211 004 1000 test
ZL-211 001 200 test
System Parameters
Intended Use Wavelength 623 nm ( or 578 nm )
Spectrum albumin reagent is intended for the in- vitro quantitative, Optical path 1 cm
diagnostic determination of albumin in human serum on both Assay type End-point
automated and manual systems. Direction Increase
Sample : Reagent Ratio 1 : 100
e.g.: Reagent volume 1 ml
Background Sample volume 10 l
Temperature 20 – 25 oC
Albumin is the major serum protein in normal individuals. It maintains Incubation time 5 minutes at 20–25oC
the plasma colloidal osmotic pressure, binds and solubilizes many Zero adjustment Reagent Blank
compounds such as calcium and bilirubin. Elevated serum albumin Sensitivity 1 g/dL
levels are usually the result of dehydration. Hyperalbuminemia is of Linearity 7 g/dL
little diagnostic significance. Hypoalbuminemia is very common in
many diseases including malabsorption, liver diseases , kidney Procedure
diseases, severe burns, infections, cancer and some genetic
abnormalities. In severe hypoalbuminemia (less than 2.5 g/dL), the Blank Standard Specimen
low plasma oncotic pressure allows water to move out of the blood
capillaries into the tissues causing edema. Reagent (R) 1 ml 1 ml 1 ml
Method Standard ------- 10 l -------
Modified Bromocresol Green colorimetric method. Specimen ------- ------- 10 l
Assay Principle
Mix and incubate for approximately 5 minutes at 20-25 oC.
Measurement of albumin is based on its binding to the indicator dye Measure absorbance of specimen (Aspecimen) and standard
bromocresol green (BCG) in pH 4.1 to form a blue-green colored (Astandard) against reagent blank within 60 minutes.
complex. The intensity of the blue-green color is directly proportional
to the concentration of albumin in the sample. It is determined by Calculation
monitoring the increase in absorbance at 623 nm, or 578 nm. Aspecimen
pH 4.1 Albumin concentration (g/dL) = x4
Albumin + BCG Albumin-BCG Complex Astandard
Reagents Quality Control
Standard albumin Normal and abnormal commercial control serum of known
4.0 g/dL. concentrations should be analyzed with each run.
Reagent (R) Performance Characteristics
Acetate Buffer 100 mmol/L
Bromocresol green 0.27 mmol/L
Detergent Precision
For further information, refer to the Albumin reagent material safety Within run (Repeatability)
data sheet.
Level 1 Level 2
Precautions and Warnings n 20 20
Do not ingest or inhalate. In case of contact with eyes or skin; rinse Mean (g/dL) 3.28 4.78
immediately with plenty of soap and water. In case of severe injuries; SD 0.08 0.12
seek medical advice immediately.
CV% 2.44 2.51
Reagent Preparation, Storage and Stability
Run to run (Reproducibility)
Spectrum albumin reagents are supplied ready-to-use and stable
up to the expiry date labeled on the bottles when stored at 2 – 8 oC. Level 1 Level 2
Once opened , the reagent is stable for 6 months and standard is
stable for 3 months at the stated temperature. n 20 20

Deterioration Mean (g/dL) 3.4 4.9

SD 0.09 0.14
Do not use the Spectrum albumin regents if precipitate forms. Failure
to recover control values within the assigned range may be an CV% 2.65 2.86
indication of reagent deterioration.
Methods of Comparison
Specimen Collection and Preservation
A comparison between Spectrum Albumin reagent and a commercial
The only acceptable anticoagulats are heparin and EDTA. Use reagent of the same methodology was performed on 200 human
preferably fresh serum. Serum should be separated immediately sera. A correlation of 0.97 was obtained.
from the clot. The biological half-life of albumin in blood is 3 weeks.
Stability: 1 day at 15 – 25 oC; 4 weeks at 4 – 8 oC;
6 months at -20 oC
Sensitivity
When run as recommended, the minimum detection limit of this assay ORDERING INFORMATION
is 1.0 g/dL.
CATALOG NO. QUANTITY
Linearity
210 001 100 test
The reaction is linear up to an albumin concentration of 7.0 g/dL; 210 002 300 test
specimens showing higher concentration should be diluted 1+1 with 210 003 600 test
physiological saline and repeat the assay (result × 2).
210 004 800 test
Interfering Substances 211 001 200 test
211 002 400 test
Haemolysis 211 003 500 test
A haemoglobin level of 800 mg/dL results in 13 % positive bias. 211 004 1000 test
ZL-211 001 200 test
Icterus
No significant interference up to a bilirubin level of 40 mg/dL.

Lipemia
No significant interference up to an intralipid level of 1000 mg/dL.

Expected Values
Adults

18 – 60 y 3.5 – 5.5 g/dL (35 – 50 g/L)

>60 y 3.4 – 4.8 g/dL (34 – 48 g/L)

Children

14-18 y 3.2-4.5 g/dL (32-45 g/L)

4d-14 y 3.8-5.4 g/dL (38-54 g/L)

Newborns

0-4 day 2.8-4.4 g/dL (28-44 g/L)

Spectrum Diagnostics does not interpret the results of a clinical

laboratory procedure ; interpretation of the results is considered
the responsibility of qualified medical personnel. All indications
of clinical significance are supported by literature references.

Analytical Range
1.0 – 7.0 g/dL.

Waste Disposal
This product is made to be used in professional laboratories.
Please consult local regulations for a correct waste disposal.
S56: dispose of this material and its container at hazardous or special
waste collection point.
S57: use appropriate container to avoid environmental contamination.
S61: avoid release in environment. Refer to special instructions/safety
data sheets.

References
1. Doumas BT,Watson WA, Biggs HG. Albumin standard and the
measurement of serum albumin with bromocresol green Clin Chim
Acta. 1971;31:87-96.
2. Grant GH, Silverman LM, Christenson RH. Amino acids and
proteins. In:Tietz NW, ed. Fundamentals of Clinical Chemistry. 3
rd ed. Philadelphia:WB Saunders;1987:291 345.
3. Tietz NW, ed. Clinical Guide to laboratory tests. 2 nd ed. Philadelphia:
WB Saunders; 1990:26-29.

Egyptian Co for Biotechnology - Spectrum Diagnostics (S.A.E)

Obour city industrial area. block 20008 piece 19 A. Cairo. Egypt.
Tel: +202 4489 2248 - Fax: +202 4489 2247
www.spectrum-diagnostics.com
E-mail:[email protected]

MDSS GmbH
EC REP Schiffgraben 41 IFUFCC52 Rev.(9),6/6/2021
30175 Hannover, Germany