03805148 Rev.

B 2007-05

Albumin (ALB)
System New Information
ADVIA 1200
® Initial release of combined methods
ADVIA 1650/1800 Initial release of combined methods
ADVIA 2400 Initial release of combined methods

NOTE: For an explanation of the symbols in this document and associated products,
refer to Understanding the Symbols located on the introductory page of the Methods
Directory.

Method Summary
Item Description
Method Principle BCG Dye Binding
Specimen Type Human serum and plasma (lithium heparin)
On-board Stability ADVIA 1200: 60 days
ADVIA 1650/1800: 60 days
ADVIA 2400: 60 days
Reagent Storage Temperature 15–25°C
Calibration Frequency ADVIA 1200: 60 days
ADVIA 1650/1800: 60 days
ADVIA 2400: 60 days
Reagent Blank (RBL) Frequency At time of method calibration
Reaction Type Endpoint (EPA)
Measurement Wavelength 596/694 nm
Standardization BCG reference method
Analytical Range Serum/Plasma: 1 – 6 g/dL
(10 – 60 g/L)
Expected Values Serum/Plasma: 3.2 – 4.8 g/dL
(32 – 48 g/L)
Reagent Code 74011
Calibrator Siemens Medical Solutions Diagnostics Chemistry
Calibrator:
REF 09784096 (PN T03-1291-62)
Controls Siemens Diagnostics Assayed Chemistry Controls:
Control 1: REF 05788372 (PN T03-1220-62)
Control 2: REF 00944686 (PN T03-1221-62)

English - 1
Intended Use
For in vitro diagnostic use in the quantitative determination of albumin in human serum
and plasma (lithium heparin) on the ADVIA Chemistry systems. Such measurements
are used in the diagnosis and treatment of chronic inflammatory diseases, collagen
diseases, and liver and kidney disorders.

Summary and Explanation 1

The Albumin (ALB) method is based on the method of Doumas, Watson, and Biggs and
uses bromocresol green solution (BCG) as a binding dye.

Principles of the Procedure

Serum or plasma albumin quantitatively binds to BCG to form an albumin-BCG
complex that is measured as an endpoint reaction at 596/694 nm.

Reaction Equation

BCG + Albumin BCG Albumin complex

Reagents
The reagents are packaged as listed below. Components of the package are available
as a kit only.

REF (PN)
Container Size Symbol Contents Amount No. of Tests
07622536 Albumin Reagent 4 x 232
(B01-4121-01) (ADVIA 1200)
4 x 555
70-mL Reagent 1 4 x 68 mL (ADVIA 1650/
1800/2400)

Components and Concentrations

Reagent Component Concentration

Reagent 1 Bromocresol Green 0.2 mmol/L
Sodium azide 0.02%

NOTE: Sodium azide can react with copper and lead plumbing to form explosive metal
azides. If disposal into a drain is in compliance with federal, state, and local
requirements, flush reagents with a large amount of water to prevent the buildup of
azides.

For In Vitro Diagnostic Use.

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 Reagent Preparation and Use
Reagents are ready to use. Before use, gently swirl the reagent to dislodge bubbles
and assure homogeneity.

On-board Reagent Stability (OBS)

System Stability
ADVIA 1200 60 days
ADVIA 1650/1800 60 days
ADVIA 2400 60 days

For all systems, unopened reagents are stable until the expiration date printed on the
product label when stored at 15° – 25°C. Do not freeze reagents.

For additional details, refer to the Methods Introduction section of the system-specific
Operator’s Guide.

Sample Handling
Siemens Diagnostics recommends using serum or plasma (lithium heparin) for this
method. The use of icteric, hemolyzed, and lipemic samples may cause a significant
interference with this method.

For additional details, refer to Sample Collection and Preparation in the Methods
Introduction section of the system-specific Operator’s Guide.

For instructions on how to load reagents and run samples, refer to the Daily Operations
section of the system-specific Operator’s Guide.

Materials Required but not Provided

The following list contains the materials required, but not provided, to perform this
method:
• sample containers
• system solutions
• calibrator and control materials (refer to the Method Summary section for the REFs)

For storage and stability information, refer to the package insert.

Calibration
Refer to the package insert supplied with the Siemens Diagnostics Chemistry Calibrator
(REF 09784096; PN T03-1291-62) for handling instructions and values. For setup and
use instructions, refer to the Calibration Overview section of the system-specific
Operator’s Guide.

Albumin (ALB) English - 3

 Calibration Frequency
Perform a calibration when this method is implemented on the system and at least at
the minimum calibration frequency, as shown in the following table:

Minimum Calibration
System Frequency*
ADVIA 1200 60 days
ADVIA 1650/1800 60 days
ADVIA 2400 60 days
*or whenever indicated by quality control data

Siemens Diagnostics recommends calibrating new reagent packs if the previous

reagent pack was calibrated any time during its on-board stability, other than as a fresh
pack.
Recalibrate after the following events:
• when the reagent lot number changes
• after replacing critical optical or hydraulic components
• when indicated by quality control procedures

Individual laboratory quality control programs and procedures may require more
frequent calibration.

Reagent Blank (RBL) Frequency

The RBL is measured at the time of method calibration.

Quality Control
Siemens Diagnostics recommends running Siemens Diagnostics Assayed Chemistry
Control 1 (REF 05788372; PN T03-1220-62) and Control 2 (REF 00944686; PN T03-
1221-62). If used, integrate these controls into your clinical laboratory’s quality control
program and procedures. Siemens Diagnostics has not evaluated the use of other
control materials with this method.

You can use commercially available assay controls with at least 2 levels (low and high).

A satisfactory level of performance is achieved when the analyte values obtained are
within the Acceptable Control Range for the system as published in the package insert
provided with the Siemens Diagnostics Assayed Chemistry Controls or within your
range, as determined by an appropriate internal laboratory quality control scheme.

The actual frequency of control in a laboratory is based on many factors, such as

workflow, system experience, and government regulation. Each laboratory should
evaluate the controls based on the frequency established by their laboratory
guidelines.

When the method is performed, Siemens Diagnostics recommends analyzing at least 2

levels of controls daily.

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 Also, assay controls under the following conditions:
• whenever you use a new reagent lot
• following the performance of any system maintenance, cleaning, or
troubleshooting procedure
• after performing a new calibration

For more information, refer to the Quality Control Overview section of the
system-specific Operator’s Guide.

Limitations of the Procedure 2

A number of substances cause physiological changes in serum or plasma analyte
concentrations. A comprehensive discussion of possible interfering substances, their
serum or plasma concentrations, and their possible physiological involvements is
beyond the scope of this document. Consult listed reference for specific details on
known potential interfering substances.2

As with any chemical reaction, you must be alert to the possible effect on results of
unknown interferences from medications or endogenous substances. The laboratory
and physician must evaluate all patient results in light of the total clinical status of the
patient.

Interferences
At the Analytical Parameters (Serum) window, you can set up the
ADVIA Chemistry system to flag different levels of lipemia (turbidity), hemolysis, and
icterus for samples run on the system.

Siemens Diagnostics tested the following potential inteferents and found the results
shown below:

ADVIA 1200
ALB Sample
Interferent Interferent Level Concentration Interference*
Bilirubin 25 mg/dL 3.5 g/dL NSI
(428 µmol/L) (34.9 g/L)
Hemolysis 525 mg/dL 3.5 g/dL NSI
(hemoglobin) (5.25 g/L) (35.0 g/L)
Lipemia 625 mg/dL 3.6 g/dL NSI
(from Intralipid) (7.06 mmol/L)** (35.8 g/L)
* NSI = No Significant Interference. A percentage effect ≥10% is considered significant
interference.
**as triolein

Albumin (ALB) English - 5

 ADVIA 1650/1800
ALB Sample
Interferent Interferent Level Concentration Interference*
Bilirubin 30 mg/dL 2.6 g/dL NSI
(513 µmol/L) (26 g/L)
3.8 g/dL NSI
(38 g/L)
Hemolysis 250 mg/dL 2.6 g/dL NSI
(hemoglobin) (2.5 g/L) (26 g/L)
3.8 g/dL NSI
(38 g/L)
525 mg/dL 2.6 g/dL +11.5%
(5.25 g/L) (26 g/L)
3.8 g/dL NSI
(38 g/L)
Lipemia 280 mg/dL 2.6 g/dL NSI
(from Intralipid) (3.16 mmol/L)** (26 g/L)
3.8 g/dL NSI
(38 g/L)
650 mg/dL 2.6 g/dL +11.5%
(7.35 mmol/L)** (26 g/L)
3.8 g/dL +10.5%
(38 g/L)
* NSI = No Significant Interference. A percentage effect ≥10% is considered significant
interference.
**as triolein

ADVIA 2400
ALB Sample
Interferent Interferent Level Concentration Interference*
Bilirubin 22.5 mg/dL 3.2 g/dL +9.4%
(385 µmol/L) (31.8 g/L)
4.7 g/dL NSI
(46.8 g/L)
30 mg/dL 3.2 g/dL +12.8%
(513 µmol/L) (31.8 g/L)
4.7 g/dL NSI
(46.8 g/L)
Hemolysis 500 mg/dL 3.3 g/dL NSI
(hemoglobin) (5 g/L) (33.0 g/L)
Lipemia 625 mg/dL 2.7 g/dL NSI
(from Intralipid) (7.06 mmol/L)** (26.9 g/L)
* NSI = No Significant Interference. A percentage effect > 10% is considered significant
interference.
**as triolein

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Performance Characteristics
Precision 3
Each sample was assayed 2 times per run, 1 or 2 runs per day, for at least 20 days.
Precision estimates were computed according to CLSI document EP05-A2, Evaluation
of Precision Performance of Quantitative Measurement Methods; Approved Guideline.3

Data contained in this section represent typical performance for

ADVIA Chemistry systems. Your laboratory data may differ from these values.

Conversion factor: g/dL x 10 = g/L

ADVIA 1200
Within-Run Total

Specimen Type Level SD CV (%) SD CV (%)

Common Units (g/dL)

Serum 2.3 0.02 0.9 0.04 1.8
Serum 2.8 0.03 1.1 0.05 1.7
Serum 3.8 0.04 1.0 0.07 1.8
SI Units (g/L)
Serum 23 0.2 0.9 0.4 1.8
Serum 28 0.3 1.1 0.5 1.7
Serum 38 0.4 1.0 0.7 1.8

ADVIA 1650/1800
Within-Run Total

Specimen Type Level SD CV (%) SD CV (%)

Common Units (g/dL)

Serum 2.1 0.03 1.6 0.05 2.4
Serum 3.4 0.03 1.0 0.06 1.8
SI Units (g/L)
Serum 21 0.3 1.6 0.5 2.4
Serum 34 0.3 1.0 0.6 1.8

Albumin (ALB) English - 7

 ADVIA 2400
Within-Run Total

Specimen Type Level SD CV (%) SD CV (%)

Common Units (g/dL)

Serum 2.2 0.03 1.4 0.04 1.8
Serum 3.9 0.02 0.6 0.04 1.1
SI Units (g/L)
Serum 22 0.3 1.4 0.4 1.8
Serum 39 0.2 0.6 0.4 1.1

Analytical Range
This method is linear from 1 – 6 g/dL (10 – 60 g/L) for serum and plasma.

Siemens Diagnostics has validated an automatic rerun condition for this method that
extends the reportable range up to 12 g/dL (120 g/L) for serum and plasma.

Expected Values 4
The expected values for this method are 3.2 – 4.8 g/dL (32 – 48 g/L).

Siemens Diagnostics provides this information for reference. Each laboratory should
establish its own normal range. You can enter normal range values and abnormal
range values at the Analytical Parameters (Chemistry) window.

System Correlation
The performance of the applicable method (y) was compared with the performance of
the same method on the comparison system (x).

ADVIA 1200
Specimen Type Comparison System (x) N Regression Equation Sy.x r Sample Range
Serum ADVIA 1650 260 y= 1.03x + 0.07 0.08 0.992 1.1 – 5.4 g/dL
y= 1.03x + 0.70 0.80 0.992 11 – 54 g/L
Plasma* ADVIA 1650 (serum) 45 y= 0.95x + 0.25 0.06 0.970 4.0 – 5.2 g/dL
y= 0.95x + 2.50 0.60 0.970 40 – 52 g/L
Serum Reference Method 53 y= 0.92x + 0.46 0.23 0.981 1.3 – 5.9 g/dL
y= 0.92x + 4.60 2.30 0.981 13 – 59 g/L
*lithium heparin

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ADVIA 1650/1800
Regression
Specimen Type Comparison System (x) N Equation Sy.x r Sample Range
Serum Technicon DAX® 156 y = 0.86x + 0.55 0.19 0.969 1.6 – 5.3 g/dL
y = 0.86x + 5.50 1.90 0.969 16 – 53 g/L
Plasma* ADVIA 1650 (serum) 58 y = 0.96x + 0.29 0.05 0.978 4.5 – 5.7 g/dL
y = 0.96x + 2.90 0.50 0.978 45 – 57 g/L
Serum Reference Method 33 y = 0.92x + 0.35 0.07 0.998 1.3 – 5.6 g/dL
y = 0.92x + 3.50 0.70 0.998 13 – 56 g/L
*lithium heparin

ADVIA 2400
Regression
Specimen Type Comparison System (x) N Equation Sy.x r Sample Range
Serum ADVIA 1650 329 y = 0.97x + 0.09 0.09 0.994 1.6 – 5.5 g/dL
y = 0.97x + 0.90 0.85 0.994 16 – 55 g/L
Serum Reference Method 33 y = 0.94x + 0.33 0.08 0.998 1.3 – 5.6 g/dL
y = 0.94x + 3.30 0.80 0.998 13 – 56 g/L

Standardization
The ADVIA ALB method is traceable to a BCG reference method, which uses reference
materials from the National Institute of Standards and Technology (NIST), via patient
sample correlation. See the correlation data in System Correlation for the relationship.
Assigned values of Siemens Diagnostics Chemistry Calibrator and
Siemens Diagnostics Assayed Chemistry Controls are traceable to this
standardization.

Bibliography
1. Doumas BT, Biggs HG. Determination of serum albumin. In: Cooper CA, ed.
Standard Methods of Clinical Chemistry. New York, NY: Academic Press, Inc.;
1972:175.
2. Young DS. Effects of Drugs on Clinical Laboratory Tests. 3rd ed. Washington:
AACC Press (1990).
3. Clinical and Laboratory Standards Institute (formerly NCCLS). Evaluation of
Precision Performance of Quantitative Measurement Methods; Approved Guideline
- Second Edition. Wayne, PA: Clinical and Laboratory Standards Institute; 2004.
NCCLS Document EP05-A2.
4. Data on file.

Albumin (ALB) English - 9

Technical Assistance
For customer support, please contact your local technical support provider or
distributor.

Trademarks
Technicon DAX and ADVIA are trademarks of Siemens Medical Solutions Diagnostics.
Intralipid is a trademark of KabiVitrium, Inc.

© 2007 Siemens Medical Solutions Diagnostics. All rights reserved.

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