Albumin FS*

Order Information Specimen

Cat. No. Kit size Human serum or heparin plasma
1 0220 99 10 021 6x 25 mL
1 0220 99 10 026 6x 100 mL Only use suitable tubes or collection containers for specimen
1 0220 99 10 023 1x 1000 mL collection and preparation.
1 0220 99 10 704 8x 50 mL
1 0220 99 10 917 10 x 60 mL When using primary tubes, follow the manufacturer's instructions.
Stability [4]:
Intended Use 10 weeks at 20 – 25°C
Diagnostic reagent for quantitative in vitro determination of albumin 5 months at 4 – 8°C
in human serum or heparin plasma on automated photometric 3 months at –20°C
systems.
Only freeze once. Discard contaminated specimens.
Summary Assay Procedure
Albumin is an important binding and transport protein for various
Basic settings for BioMajesty® JCA-BM6010/C
substances in plasma and the main contributor to the plasma
osmotic pressure. Measurement of albumin in serum is used for Wavelength 596/694 nm
diagnosis and monitoring of liver diseases, e.g. liver cirrhosis. Temperature 37°C
Furthermore, albumin levels indicate the health and nutritional Measurement Endpoint
status of an individual and, therefore, are used for detecting Sample/Calibrator 1.0 µL
malnutrition and for prognosis in elderly hospitalized patients. [1,2] Reagent 90 µL
Addition reagent Cycle 19 (286 s)
Method Absorbance Cycle 7/9 (95 s/122 s)
Photometric test using bromocresol green Calibration Linear
In the presence of bromocresol green at a slightly acid pH, serum
albumin produces a color change of the indicator from yellow-green Calculation
to green-blue. With calibrator
A Sample
Reagent Albumin [g/dL] = x Conc. Cal. [g/dL]
A Cal.
Components and Concentrations
Citrate buffer pH 4.2 30 mmol/L Conversion Factor
Bromocresol green 0.26 mmol/L Albumin [g/dL] x 144.9 = Albumin [µmol/L]
Storage and Stability Calibrators and Controls
Reagent is stable up to the date of expiry indicated on the kit, if DiaSys TruCal U is recommended for calibration. Calibrator values
stored at 2 - 25°C and contamination is avoided. Do not freeze and have been made traceable to the reference material ERM-DA470.
protect from light. Albumin Standard FS may be used alternatively for calibration. Use
The in-use stability of the reagent is 18 months. DiaSys TruLab N and P for internal quality control. Quality control
must be performed after calibration. Control intervals and limits have
Warnings and Precautions to be adapted to the individual requirements of each laboratory.
1. In very rare cases, samples of patients with gammopathy might Results must be within the defined ranges. Follow the relevant legal
give falsified results [3]. requirements and guidelines. Each laboratory should establish
2. In case of product malfunction or altered appearance that could corrective action in case of deviations in control recovery.
affect the performance, contact the manufacturer. Cat. No. Kit size
3. Any serious incident related to the product must be reported to TruCal U 5 9100 99 10 063 20 x 3 mL
the manufacturer and the competent authority of the Member 5 9100 99 10 064 6 x 3 mL
State where the user and/or patient is located. TruLab N 5 9000 99 10 062 20 x 5 mL
4. Please refer to the safety data sheets (SDS) and take the 5 9000 99 10 061 6 x 5 mL
necessary precautions for the use of laboratory reagents. For TruLab P 5 9050 99 10 062 20 x 5 mL
diagnostic purposes, the results should always be assessed 5 9050 99 10 061 6 x 5 mL
with the patient’s medical history, clinical examinations and Albumin Standard FS 1 0200 99 10 030 6 x 3 mL
other findings.
5. For professional use only. Performance Characteristics
Waste Management Data evaluated on BioMajesty® JCA-BM6010/C
Refer to local legal requirements for chemical disposal regulations Exemplary data mentioned below may slightly differ in case of
as stated in the relevant SDS to determine the safe disposal. deviating measurement conditions.
Warning: Handle waste as potentially biohazardous material. Measuring range up to 6 g/dL.
Dispose of waste according to accepted laboratory instructions and When values exceed this range samples should be diluted
procedures. 1 + 1 with NaCl solution (9 g/L) and the result multiplied by 2.
Reagent Preparation Limit of detection** 0.1 g/dL
The reagent is ready to use. Interfering substance Interferences
≤ 10% up to
Materials Required Ascorbic acid 30 mg/dL
General laboratory equipment
Bilirubin (conjugated and unconjugated) 60 mg/dL
Hemoglobin 300 mg/dL
Lipemia (triglycerides) 1200 mg/dL
For further information on interfering substances, refer to the literature [5-
7].

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 Precision
Within run (n=20) Sample 1 Sample 2 Sample 3
Mean [g/dL] 3.26 4.03 4.48
CV [%] 1.00 0.63 1.02
Between day (n=20) Sample 1 Sample 2 Sample 3
Mean [g/dL] 3.96 4.53 2.46
CV [%] 0.73 0.98 1.42
Method comparison (n=100)
Test x Competitor Albumin
Test y DiaSys Albumin FS
Slope 0.987
Intercept 0.168 g/dL
Coefficient of correlation 0.997
** lowest measurable concentration which can be distinguished from zero;
mean + 3 SD (n = 20) of an analyte free specimen.

Reference Range [8]

Adults: 3.5 – 5.2 g/dL 507 – 756 µmol/L
Each laboratory should check if the reference ranges are
transferable to its own patient population and determine own
reference ranges if necessary.

Literature
1. Johnson AM, Rohlfs EM, Silverman LM. Proteins. In: Burtis CA,
Ashwood ER. editors. Tietz textbook of clinical chemistry. 3rd
ed. Philadelphia: W. B. Saunders Company; 1999. p. 477-540.
2. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt:
TH-Books Verlagsgesellschaft; 1998. p. 652-6.
3. Bakker AJ, Mücke M. Gammopathy interference in clinical
chemistry assays: mechanisms, detection and prevention.
ClinChemLabMed 2007;45(9):1240-1243.
4. Guder WG, Zawta B et al. The Quality of Diagnostic Samples.
1st ed. Darmstadt: GIT Verlag; 2001; p. 14-5.
5. Young DS. Effects of Drugs on Clinical Laboratory Tests. 5th
ed. Volume 1 and 2. Washington, DC: The American
Assocation for Clinical Chemistry Press 2000.
6. Young DS. Effects on Clinical Laboratory Tests - Drugs
Disease, Herbs & Natural Products, https://clinfx.wiley.com/
aaccweb/aacc/, accessed in February 2021. Published by
AACC Press and John Wiley and Sons, Inc.
7. Sonntag O, Scholer A. Drug interference in clinical chemistry:
recommendation of drugs and their concentrations to be used
in drug interference studies. Ann Clin Biochem. 2001
Jul;38:376-85.
8. 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.
Additions and/or changes in the document are highlighted in grey.
For deletions, please refer to the customer information for the
corresponding edition number of the package inserts.
DiaSys Diagnostic Systems GmbH
Alte Strasse 9 65558 Holzheim
Germany
www.diasys-diagnostics.com

* Fluid Stable

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