Albumin FS *

Diagnostic reagent for quantitative in vitro determination of albumin in serum or plasma on photometric
systems

Order Information Materials required but not provided

Cat. No. Kit size NaCl solution 9 g/L
1 0220 99 10 021 R 5x 25 mL + 1 x 3 mL Standard General laboratory equipment
1 0220 99 10 026 R 6x 100 mL
1 0220 99 10 023 R 1x 1000 mL Specimen
1 0220 99 10 704 R 8x 50 mL
1 0220 99 10 917 R 10 x 60 mL
Serum, heparin plasma or EDTA plasma
1 0220 99 90 314 R 12 x 25 mL Stability [3]:
1 0200 99 10 030 6x 3 mL Standard 10 weeks at 20 – 25°C
5 months at 4 – 8°C
Summary [1,2] 3 months at –20°C
Albumin is an important binding and transport protein for various Only freeze once!
substances in plasma and the main contributor to the plasma Discard contaminated specimens!
osmotic pressure. Measurement of albumin in serum is used for
diagnosis and monitoring of liver diseases, e.g. liver cirrhosis. Assay Procedure
Furthermore, albumin levels indicate the health and nutritional
Application sheets for automated systems are available on
status of an individual and, therefore, are used for detecting
request.
malnutrition and for prognosis in elderly hospitalized patients.
Wavelength Hg 546 nm, 540 – 600 nm
Method Optical path 1 cm
Photometric test using bromocresol green Temperature 20 – 25°C/37°C
Measurement Against reagent blank
Principle
In the presence of bromocresol green at a slightly acid pH, serum Blank Sample or standard
albumin produces a color change of the indicator from yellow- Sample or standard - 10 µL
green to green-blue. Dist. Water 10 µL -
Reagent 1000 µL 1000 µL
Reagents Mix, incubate for approx. 10 min. and read the absorbance
against reagent blank within 60 min.
Components and Concentrations
Citrate buffer pH 4.2 30 mmol/L Calculation
Bromocresol green 0.26 mmol/L With standard or calibrator
Standard: 5 g/dL
Storage Instructions and Reagent Stability A Sample
Albu min [g/dL] = × Conc. Std / Cal [g/dL]
The reagent is stable up to the end of the indicated month of A Std / Cal
expiry, if stored at 2 – 25 °C, protected from light and
Conversion factor
contamination is avoided. Do not freeze the reagent!
The standard is stable up to the end of the indicated month of Albumin [g/dL] x 144.9 = Albumin [µmol/L]
expiry, if stored at 2 – 8 °C.
Calibrators and Controls
Warnings and Precautions For the calibration of automated photometric systems the DiaSys
1. The standard contains biological material. Handle the product TruCal U calibrator is recommended. The assigned values of
as potentially infectious according to universal precautions TruCal U have been made traceable to the reference material
and good clinical laboratory practices. ERM-DA470. For internal quality control DiaSys TruLab N and P
2. In very rare cases, samples of patients with gammopathy controls should be assayed. Each laboratory should establish
might give falsified results [6]. corrective action in case of deviations in control recovery.
3. Please refer to the safety data sheet and take the necessary
Cat. No. Kit size
precautions for the use of laboratory reagents. For diagnostic TruCal U 5 9100 99 10 063 20 x 3 mL
purposes, the results should always be assessed with the 5 9100 99 10 064 6 x 3 mL
patient`s medical history, clinical examinations and other TruLab N 5 9000 99 10 062 20 x 5 mL
findings. 5 9000 99 10 061 6 x 5 mL
4. For professional use only! TruLab P 5 9050 99 10 062 20 x 5 mL
5 9050 99 10 061 6 x 5 mL
Waste Management
Please refer to local legal requirements.
Reagent Preparation
The reagent and the standard are ready to use.

Albumin FS – Page 1 * fluid stable

Performance Characteristics Reference Range [4]
Adults: 3.5 – 5.2 g/dL
Measuring Range
35 – 52 g/L
The test has been developed to determine albumin concentrations 507 – 756 µmol/L
within a measuring range from 0.2 – 6 g/dL. When values exceed
this range samples should be diluted 1 + 1 with NaCl solution Each laboratory should check if the reference ranges are
(9 g/L) and the result multiplied by 2. transferable to its own patient population and determine own
reference ranges if necessary.
Specificity/Interferences
No interference was observed by ascorbic acid up to 30 mg/dL, Literature
bilirubin up to 40 mg/dL, hemoglobin up to 400 mg/dL and lipemia 1. Johnson AM, Rohlfs EM, Silverman LM. Proteins. In: Burtis
up to 500 mg/dL triglycerides. For further information on interfering CA, Ashwood ER. editors. Tietz textbook of clinical chemistry.
substances refer to Young DS [5]. rd
3 ed. Philadelphia: W. B. Saunders Company; 1999. p.477-
Sensitivity/Limit of Detection 540.
st
The lower limit of detection is 0.2 g/dL. 2. Thomas L. Clinical Laboratory Diagnostics. 1 ed. Frankfurt:
TH-Books Verlagsgesellschaft; 1998. p. 652-6.
Precision (at 25°C) 3. Guder WG, Zawta B et al. The Quality of Diagnostic Samples.
st
Intra-assay precision Mean SD CV 1 ed. Darmstadt: GIT Verlag; 2001; p. 14-5.
n = 20 [g/dL] [g/dL] [%] 4. Dati F, Schumann G, Thomas L, Aguzzi F, Baudner S,
Sample 1 3.52 0.03 0.91 Bienvenu J et al. Consensus of a group of professional
Sample 2 4.50 0.05 1.12 societies and diagnostic companies on guidelines for interim
Sample 3 6.89 0.12 1.79 reference ranges for 14 proteins in serum based on the
standardization against the IFCC/BCR/CAP reference
Inter-assay precision Mean SD CV material (CRM 470). Eur J Clin Chem Clin Biochem
n = 20 [g/dL] [g/dL] [%] 1996;34:517-20.
Sample 1 3.35 0.05 1.58 5. Young DS. Effects of Drugs on Clinical Laboratory Tests. 5th
Sample 2 4.32 0.06 1.44 ed. Volume 1 and 2. Washington, DC: The American
Sample 3 6.73 0.11 1.60 Assocation for Clinical Chemistry Press 2000.
6. Bakker AJ, Mücke M. Gammopathy interference in clinical
Method Comparison chemistry assays: mechanisms, detection and prevention.
A comparison of DiaSys Albumin FS (y) with a commercially ClinChemLabMed 2007;45(9):1240-1243.
available assay (x) using 59 samples gave following results:
y = 1.00 x – 0.11 g/dL; r = 0.998 Manufacturer
DiaSys Diagnostic Systems GmbH
IVD Alte Strasse 9 65558 Holzheim Germany

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