ALBUMIN TEST PROCEDURE REFERENCES

Doumas et al., Standard Methods of Clinical Chemistry,

Wavelenght: 628 nm (allowed 580 ÷ 630 nm) Vol. 7, pag. 175-189, Academic Press Chicago (1972).
BC 0100 CH 2 x 50 ml Lightpath: 1 cm Tietz Textbook of Clinical Chemistry, Second Edition,
BC 0500 CH 4 x 125 ml Temperature: 25, 30 or 37°C Burtis-Ashwood (1994).
BC 1500 CH 6 x 250 ml dispense: blank standard sample MANUFACTURER
reagent 3 ml 3 ml 3 ml
SUMMARY OF TEST Chema Diagnostica
water 20 µl - - Via Campania 2/4
Plasma levels of albumin, because they depend on pro-
standard - 20 µl - 60030 Monsano (AN) - ITALY - EU
tein intake, are frequently used to assess nutritional status.
sample - - 20 µl phone +39 0731 213360
Moderate to large changes in plasma concentration of
fax +39 0731 213361
albumin have significant effects on the relative amounts
Mix, incubate at 25, 30 or 37°C for 2 minutes. e-mail: [email protected]
of the bound and free concentrations of the ligands it
Read absorbances of standard (As) and samples (Ax) website: http://www.chema.com
carries; because free ligands are those that interact with
tissue receptor sites and that can be excreted, plasma against reagent blank.
SYMBOLS
albumin levels have important influences on the metabo-
lism of endogenous substances such as calcium, bilirubin, RESULTS CALCULATION
and fatty acids and on the effects of drugs and hormones.
serum/plasma sample:
Albumin levels, although important for management and
follow-up, have very little value in diagnosis. Hyperalbumi-
albumin g/dl = Ax/As x 4 (standard value)
nemia is of little diagnostic significance except in dehydra-
tion. Hypoalbuminemia, however, is very common in many EXPECTED VALUES
illnesses and results in most instances from one or more of
the following factors: Men 4.2 - 5.5 g/dl
1. Impaired synthesis, either primary as in liver disease or Women 3.7 - 5.3 g/dl
secondary to diminished protein intake.
2. Increased catabolism as a result of tissue damage and Each laboratory should establish appropriate reference
inflammation. intervals related to its population.
3. Reduced absorption of amino acids caused by malab-
sorption syndromes or malnutrition. QUALITY CONTROL AND CALIBRATION
4. Protein loss: in urine, due to nephrotic syndrome, chro-
nic glomerulonephritis, diabetes, or systemic lupus erythe- It is suggested to perform an internal quality control. For
matosus; in feces, due to protein-losing enteropathy arising this purpose the following human based control sera are
from inflammatory or neoplastic disease; or from the skin available:
through burns. QN 0050 CH QUANTINORM CHEMA 10 x 5 ml
5. Altered distribution that may sequester large amounts of with normal or close to normal control values
albumin in an extravascular compartment, as for instance QP 0050 CH QUANTIPATH CHEMA 10 x 5 ml
in ascites, when high pressure in the portal circulation with pathological control values.
drives albumin into the peritoneal fluid. If required, a multiparametric, human based calibrator is
Determination of albumin in serum or plasma is usually available:
based on the binding behavior of the protein with the anio- AT 0030 CH AUTOCAL H 10 x 3 ml
nic dyes bromcresol green (BCG) or bromcresol purple
(BCP) in a manual or automated procedure. The present Please contact Customer Care for further information.
method is based on BCG in acidic environment.
TEST PERFORMANCE
PRINCIPLE OF THE METHOD Linearity
Albumin and BCG are followed to bind at pH 4.2, and the method is linear up to 6 g/dl.
absorption of the BCG-albumin complex is determined If the limit value is exceeded, it is suggested to dilute
spectrophotometrically at 628 nm. At pH 4.2, albumin acts sample 1+9 with saline and to repeat the test, multiplying
as a cation to bind the anionic dye. the result by 10.
KIT COMPONENTS
Sensitivity/limit of detection (LOD)
For in vitro diagnostic use only. the limit of detection is 0.01 g/dl.
The components of the kit are stable until expiration date
on the label. Interferences
Keep away from direct light sources. no interference was observed by the presence of:
hemoglobin ≤ 350 mg/dl
Reagent A 0100: 2 x 50 ml (liquid) blue cap bilirubin ≤ 27 mg/dl
0500: 4 x 125 ml (liquid) blue cap lipids ≤ 850 mg/dl
1500: 6 x 250 ml (liquid) blue cap
Precision
Composition: succinate buffer 100 mM pH 4.2, bromochre- intra-assay (n=10) mean (g/dl) SD (g/dl) CV%
sol green 0.2 mM, surfactant. sample 1 3.37 0.04 1.10
sample 2 3.34 0.04 1.30
Standard: albumin solution 4 g/dl - 5 ml
inter-assay (n=20) mean (g/dl) SD (g/dl) CV%
Store all components at 2-8°C. sample 1 3.36 0.04 1.00
MATERIALS REQUIRED BUT NOT SUPPLIED sample 2 3.35 0.07 2.00
Current laboratory instrumentation. Spectrophotometer
Methods comparison
UV/VIS with thermostatic cuvette holder. Automatic micro-
a comparison between Chema and a commercially availa-
pipettes. Glass or high quality polystyrene cuvettes. Saline
ble product gave the following results:
solution.
REAGENT PREPARATION Albumin Chema = x
Albumin competitor = y
Use reagent ready to use.
n = 73
Stability: up to expiration date on labels at 2-8°C.
Stability since first opening of vials: preferably within 60
y = 1.009x - 0.195 g/dl r2 = 0.956
days at 2-8°C.
WASTE DISPOSAL
PRECAUTIONS
This product is made to be used in professional laborato-
Reagent may contain some non-reactive and preservative ries. Please consult local regulations for a correct waste
components. It is suggested to handle carefully it, avoiding disposal.
contact with skin and swallow. S56: dispose of this material and its container at hazar-
Perform the test according to the general “Good Labora- dous or special waste collection point.
tory Practice” (GLP) guidelines. S57: use appropriate container to avoid environmental
contamination.
SPECIMEN S61: avoid release in environment. Refer to special instruc-
Serum (preferred), plasma (heparinate or EDTA). tions/safety data sheets.
Venostasis should be avoided in specimen collection
because hemoconcentration increases the apparent con-
centrations of albumin and other plasma proteins.

IUS-7.5 UK rev. 23/05/2011 ©