DIALAB Produktion und Vertrieb von chemisch – technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.

A – 2351 Wiener Neudorf, Austria, IZ-NÖ Süd, Hondastrasse, Objekt M55

Phone: ++43 (0) 2236 660910-0, Fax: ++43 (0) 2236 660910-30, e-mail: office@dialab.at

Liquid Reagent – ready to use STANDARD

(not included in the kit; has to be ordered separately)
Concentration 5 g/dL (50 g/L)
ALBUMIN Storage: 2 – 8 °C
BCG Stability: up to the indicated expiration date
Single Reagent CLOSE IMMEDIATELY AFTER USE!
INTERFERING SUBSTANCES
Diagnostic Reagent for quantitative in vitro determination
no interference up to:
of Albumin in human serum or plasma on photometric
Ascorbic acid 30 mg/dL
systems.
Bilirubin 40 mg/dL
Hemoglobin 400 mg/dL
Triglycerides 500 mg/dL
REF Kit Size Configuration
For further information on interfering substances refer to
D95557B 1 x 10 L Single Reagent
Young DS [5].
D97202B 1 x 1000 mL Single Reagent
D09550 4 x 250 mL Single Reagent MANUAL TEST PROCEDURE
D97203 5 x 100 mL Single Reagent Bring reagents and samples to room temperature.
D00204 5 x 50 mL Single Reagent Pipette into Blank Std./Cal. Sample
D00205 5 x 25 mL Single Reagent test tubes
D00206 5 x 10 mL Single Reagent
D51911 10 x 50 mL Single Reagent Reagent 1000 µL 1000 µL 1000 µL
D0401917 9 x 65 mL Single Reagent Sample - - 10 µL
DA0801 5 x 50 mL Single Reagent
DT1001 4 x 50 mL Single Reagent Std./Cal. - 10 µL -
DK0701 5 x 50 mL Single Reagent Dist. water 10 µL - -
DB0901 2 x 150 mL Single Reagent
Mix, Incubate for approx. 10 min. at 20 – 25 °C / 37 °C and
Additionally offered: read absorbance against reagent blank within 60 min.
D95555 1 x 3 mL Albumin Standard
D98485 5 x 3 mL Calibrator Diacal Auto CALCULATION
D98485SV 1 x 3 mL Calibrator Diacal Auto A Sample
Albumin (g/dL) = x Conc. of Std/Cal (g/dL)
D98481 12 x 5 mL Control normal Diacon N A Std/Cal
D14481 5 x 5 mL Control normal Diacon N
D98481SV 1 x 5 mL Control normal Diacon N UNIT CONVERSION
D98482 12 x 5 mL Control abnormal Diacon P g/dL x 10 = g/L
D14482 5 x 5 mL Control abnormal Diacon P g/dL x 144.9 = µmol/L
D98482SV 1 x 5 mL Control abnormal Diacon P REFERENCE RANGE [4] *
g/dL g/L µmol/L
TEST PARAMETERS Adults: 3.5 - 5.2 35 - 52 507 - 756
* Each laboratory should check if the reference ranges are
Method: Colorimetric, Endpoint, transferable to its own patient population and determine own reference
Increasing Reaction, BCG ranges if necessary.
Wavelength: Hg 546 nm, 540 – 600 nm DIAGNOSTIC IMPLICATION [1,2]
Temperature: 20 – 25 °C / 37 °C Measurement of albumin in serum is used for diagnosis and
Sample: Serum, heparin or EDTA plasma monitoring of liver diseases, e.g. liver cirrhosis. Furthermore,
Linearity: up to 6 g/dL albumin levels indicate the health and nutritional status of an
individual and, therefore, are used for detecting malnutrition
Sensitivity: The lower limit of detection is 0.2 g/dL
and for prognosis in elderly hospitalized patients.
REAGENT COMPOSITION TEST PRINCIPLE
COMPONENTS CONCENTRATION In the presence of bromocresol green at a slightly acid pH,
Citrate buffer, pH 4.2 30 mmol/L serum albumin produces a color change of the indicator from
Bromocresol green 0.26 mmol/L yellow-green to green-blue. The intensity of the blue-green
REAGENT PREPARATION color is proportional to the concentration of albumin in the
The reagent provided is ready for use. sample.

REAGENT STABILITY AND STORAGE PERFORMANCE CHARACTERISTICS

Conditions: Protect from light LINEARITY
Close immediately after use The assay is linear from 0.2 to 6 g/dL.
Avoid contamination Samples with albumin concentrations higher than 6 g/dL
Do not freeze the reagent. should be diluted 1 + 1 with NaCl solution (9 g/L) and the
Storage: at 2 – 25 °C result multiplied by 2.
Stability: up to the indicated expiration date PRECISION (at 25 °C)
SAMPLE STABILITY AND STORAGE Intra-assay Mean SD CV
Stability [3]: 15 – 25 °C 10 weeks n = 20 [g/dL] [g/dL] [%]
4 – 8 °C 5 months Sample 1 3.52 0.03 0.91
- 20 °C 3 months Sample 2 4.50 0.05 1.12
Only freeze once! Sample 3 6.89 0.12 1.79
Discard contaminated specimens. Inter-assay Mean SD CV
MATERIALS REQUIRED BUT NOT PROVIDED n = 20 [g/dL] [g/dL] [%]
Sample 1 3.35 0.05 1.58
NaCl solution (9 g/L)
Sample 2 4.32 0.06 1.44
General laboratory equipment
Sample 3 6.73 0.11 1.60

S:\pm\allg\Inserts_PM\Inserts_word\clinical chemistry\albumin_rev02.doc Page 1 of 2 DI M. Wagner Rev.02, 03.06.2014.

 DIALAB Produktion und Vertrieb von chemisch – technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
A – 2351 Wiener Neudorf, Austria, IZ-NÖ Süd, Hondastrasse, Objekt M55
Phone: ++43 (0) 2236 660910-0, Fax: ++43 (0) 2236 660910-30, e-mail: office@dialab.at

METHOD COMPARISON
A comparison of Dialab Albumin (y) with a commercially
available assay (x) using 59 samples gave following results:
y = 1.00 x – 0.11 g/dL; r = 0.998.
QUALITY CONTROL
All control sera with Albumin values determined by this
method can be used.
We recommend the Dialab controls Diacon N (control serum
with values in the normal range) and Diacon P (control serum
with values in the abnormal range).
CALIBRATION
The assay requires the use of an albumin standard or an
albumin calibrator.
We recommend the Dialab Albumin Standard and the Dialab
multi calibration serum Diacal Auto.
The assigned values of Diacal Auto have been made
traceable to the reference material ERM-DA470.
AUTOMATION
Special adaptations for automated analyzers can be made on
request.
WARNINGS AND PRECAUTIONS
1. In very rare cases, samples of patients with gammopathy
might give falsified results.
2. Please refer to the safety data sheets and take the
necessary precautions for the use of laboratory reagents.
3. For diagnostic purposes, the results should always be
assessed with the patient’s medical history, clinical
examinations and other findings.
WASTE MANAGEMENT
Please refer to local legal requirements.
REFERENCES
1. Johnson AM, Rohlfs EM, Silverman LM. Proteins. In:
Burtis CA, Ashwood ER. editors. Tietz textbook of clinical
rd
chemistry. 3 ed. Philadelphia: W.B. Saunders Company;
1999. p.447-540.
st
2. Thomas L. Clinical Laboratory Diagnostics. 1 ed.
Frankfurt: TH-Books Verlagsgesellschaft; 1998. p.652-6.
3. Guder WG, Zawta B et al. The Quality of Diagnostic
st
Samples. 1 ed. Darmstadt: GIT Verlag; 2001; p.14-5.
4. Dati F, Schumann G, Thomas L, Aguzzi F, Baudner S,
Bienvenu J et al. Consensus of a group of professional
societies and diagnostic companies on guidelines for
interim reference ranges for 14 proteins in serum based
on the standardization against the IFCC/BCR/CAP
reference material (CRM 470). Eur J Clin Chem Clin
Biochem 1996; 34: 517-20.
5. Young DS. Effects of Drugs on Clinical Laboratory Tests.
th
5 ed. Volume 1 and 2. Washington, DC: The American
Association for Clinical Chemistry Press 2000.

S:\pm\allg\Inserts_PM\Inserts_word\clinical chemistry\albumin_rev02.doc Page 2 of 2 DI M. Wagner Rev.02, 03.06.2014.