Siemens Healthcare Diagnostics Inc.

Instructions for Use

2011-01

Albumin (ALB)
System New Information
ADVIA® 1200 Updates: New document number; Symbols page added
ADVIA 1650/1800 Updates: New document number; Symbols page added
ADVIA 2400 Updates: New document number; Symbols page added

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 Healthcare Diagnostics Chemistry Calibrator:
REF 09784096 (PN T03-1291-62)

© 2008 Siemens Healthcare Diagnostics Inc. All rights reserved.

Siemens Healthcare Diagnostics Inc., Tarrytown, NY 10591-5097 USA
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Albumin (ALB)

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)

Safety data sheets (MSDS/SDS) available on www.siemens.com/diagnostics.

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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Albumin (ALB)

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 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 (refer to the Method Summary section for the REFs)
• control materials

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

Calibration
Refer to the package insert supplied with the Siemens 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.

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Albumin (ALB)

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 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
Follow government regulations or accreditation requirements for quality control
frequency.

Siemens recommends the use of commercially available quality control materials 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 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, analyze at least 2 levels of controls daily.

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.

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Albumin (ALB)

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 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

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Albumin (ALB)

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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Albumin (ALB)

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

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Albumin (ALB)

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 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 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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Albumin (ALB)

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 Chemistry Calibrator 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.

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

www.siemens.com/diagnostics

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

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Albumin (ALB)

Understanding the Symbols

The following symbols may appear on the product labeling:

Symbol Definition Symbol Definition

In vitro diagnostic medical device Catalog number

Authorized Representative in the European

Manufacturer
Community

CE Mark with identification number of notified

CE Mark
body

Consult instructions for use Caution! Potential Biohazard

Do not freeze (> 0°C) Temperature limitation (2–8°C)

Lower limit of temperature ( 2°C) Upper limit of temperature ( -10°C)

Keep away from sunlight Use by

Store upright Contains sufficient for (n) tests

Batch code Printed with soy ink

2010-01 Date format (year-month) Recycle

Green dot

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