ALBUMIN FLUID MONOREAGENT IVD

Determination of ALBUMIN in Body Fluids (Bromcresolgreen Method)

MEASUREMENT PRINCIPLE ASSAY PROCEDURE

Albumin + BCG → Albumin-BCG-complex Wavelength: 578 nm

Temperature: 25°/ 37°C
The reaction between albumin in serum or EDTA plasma and the
dye bromcresol-green produces a change in colour to blue-green, Pipette into cuvettes:
that is proportional to the albumin concentration. Standard Sample
Reagent 1000 µl 1000 µl
CONCENTRATION OF WORKING SOLUTION Serum or EDTA plasma - 10 µ1
Monoreagent Standard 10 µl -
Succinate pH 4.2 75.00 mmol/l
Bromcresolgreen 0.15 mmol/l Mix and incubate for 10 minutes at 25° or 5 minutes at 37°C.
Brij 35 Detergent 2 g/l Measure the absorbance of the sample A(S) and of the standard
(Standard 4 g/dl) A(STD) against the reagent as the blank A(BL).

STORAGE AND STABILITY

The sealed reagents are stable up to the indicated expiry date if CALCULATION
stored at +18° - +22°C. A(S) - A(BL)
g/dl Albumin = x4
INTENDED USE A(STD) - A(BL)
In vitro test for the quantitative determination of Albumin in human
serum and plasma. NOTE:
After opening the standard has to be stored at +2°- +8°C.
PRECAUTIONS AND WARNINGS
For in vitro diagnostic use only. Attend to the normal precautions APPLICATIONS:
required for handling all laboratory reagents. Applications are available for many analyzers after request
EXPECTED VALUES LITERATURE:
Doumas, B. T. et al : Clin . Chim . Acta 31 , 87pp ( 1971 ); Weis,
g/dl W.A.. Klin.Wochenschr. 43, S.273 (1965)
Newborn 0 – 4 days 2.8 – 4.4
Children 4 days – 14 years 3.8 – 5.4 PACKAGE SIZES:
14 – 18 years 3.2 – 4.5
Adults 3.4 – 4.8 KIT SIZE ORDER NO.
2 x 50 ml Manual AF01000050
SAMPLE MATERIAL 4 x 100 ml manual AF01000100
Serum or EDTA plasma. 1 x 400 ml manual AF01R05100
2 x 500 ml manual AF01000500
QUALITY CONTROL 10 x 50 ml for Hitachi AF01911050
Centronorm, Centropath or all other control sera with ALBUMIN 704/902/717/911
values determinated by this method may be employed. 5 x 100 ml for Hitachi 717/911 AF01911100
6 x 100 ml for Hitachi 911 barc. AF01911100-B
10 x 67 ml for Hitachi 917/ AF01917067-B
LINEARITY
Modular-P
Up to 8 g/dl ( 80 g/l); samples with higher concentrations dilute 1+1 10 x 67 ml for Olympus AU AF01917067
with 0.9% NaCI solution. Multiply the result by 2. 10 x 25 ml for Selectra AF01SEL025

TEST SPECIFICATIONS
Reproducibility in Intraassay and Interassay on Hitachi 717:

Within run (n= 30) Between run (n= 30)

Mean SD Mean SD
Sample %CV %CV
g/dl g/dl g/dl g/dl
Level 1 3.4 0.07 2.12 3.6 0.06 1.64
Level 2 4.7 0.06 1.27 4.8 0.07 1.50
Level 3 6.5 0.13 1.97

TEST COMPARISION:
Comparision with a test of the market leader on the Hitachi 717:
n = 55; r = 0.9108; y = 1.0221x – 0.1875

Centronic GmbH Am Kleinfeld 11,

85456 Wartenberg/Germany
Phone: 0049-8762724300, Fax: 0049-8762724312
Edition 04/2013, TV-003-CE-003 e-mail: info@centronic-gmbh.com
web: www.centronic-gmbh.com