ALBUMIN BCG

7D53-22
304570/R01

ALBUMIN BCG
This package insert contains information to run the Albumin BCG assay on the ARCHITECT c Systems and the
AEROSET System.

NOTE: This package insert must be read carefully prior to product use. Package insert instructions must be
followed accordingly. Reliability of assay results cannot be guaranteed if there are any deviations from the
instructions in this package insert.

Customer Support
United States: 1-877-4ABBOTT
Canada: 1-800-387-8378 (English speaking customers)
1-800-465-2675 (French speaking customers)
International: Call your local Abbott representative

Symbols in Product Labeling

Calibrator 1 Reagent 1

Calibrator 2 Catalog number/List number

Concentration Serial number

Contents of kit Consult instructions for use

Authorized Representative in the

Contains mercury. Dispose of properly.
European Community

Ingredients Manufacturer

In vitro diagnostic medical device Temperature limitation

Batch code/Lot number Use by/Expiration date

May 2010
©2010 Abbott Laboratories

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NAME SPECIMEN COLLECTION AND HANDLING
ALBUMIN BCG Suitable Specimens
Serum and plasma are acceptable specimens.
INTENDED USE
• Serum: Use serum collected by standard venipuncture techniques
The Albumin BCG assay is used for the quantitation of albumin in
into glass or plastic tubes with or without gel barriers. Ensure
human serum or plasma.
complete clot formation has taken place prior to centrifugation.
When processing samples, separate serum from blood cells or
SUMMARY AND EXPLANATION OF TEST gel according to the specimen collection tube manufacturer’s
Albumin is the major serum protein in normal individuals. Elevated instructions.
serum albumin levels are usually the result of dehydration. Decreased Some specimens, especially those from patients receiving
albumin levels are found in a wide variety of conditions, including anticoagulant or thrombolytic therapy, may take longer to complete
kidney disease, liver disease, malabsorption, malnutrition, severe burns, their clotting processes. Fibrin clots may subsequently form in these
infections, and cancer. sera and the clots could cause erroneous test results.
PRINCIPLES OF PROCEDURE • Plasma: Use plasma collected by standard venipuncture techniques
into glass or plastic tubes. Acceptable anticoagulants are lithium
The Albumin BCG procedure is based on the binding of bromcresol heparin (with or without gel barrier) and sodium heparin. Ensure
green specifically with albumin to produce a colored complex. The centrifugation is adequate to remove platelets. When processing
absorbance of the complex at 628 nm is directly proportional to the samples, separate plasma from blood cells or gel according to the
albumin concentration in the sample. specimen collection tube manufacturer’s instructions.
Methodology: Bromcresol Green
For total sample volume requirements, refer to the instrument-specific
REAGENTS ASSAY PARAMETERS section of this package insert and Section 5 of
the instrument-specific operations manual.
Reagent Kit
7D53 Albumin BCG is supplied as a liquid, ready-to-use, single Specimen Storage
reagent kit which contains: Serum and Plasma
10 x 84 mL Temperature Maximum Bibliographic
Estimated tests per kit: 2,607 Storage Reference
Calculation is based on the minimum reagent fill volume per kit. 20 to 25°C 2.5 months 5
Reactive Ingredients Concentration 2 to 8°C 5 months 5, 6
Bromcresol Green 0.27 mmol/L -20°C 3 months 5
TRIS 55 mmol/L Guder et al.5 suggest storage of frozen specimens at -20°C for
Succinic Acid 100 mmol/L no longer than the time interval cited above. However, limitations
of laboratory equipment make it necessary in practice for clinical
Thimerosal 0.250 g/L laboratories to establish a range around -20°C for specimen storage.
This temperature range may be established from either the freezer
REAGENT HANDLING AND STORAGE manufacturer’s specifications or your laboratory standard operating
procedure(s) for specimen storage.
Reagent Handling
Remove air bubbles, if present in the reagent cartridge, with a new NOTE: Stored specimens must be inspected for particulates. If present,
applicator stick. Alternatively, allow the reagent to sit at the appropriate mix and centrifuge the specimen to remove particulates prior to testing.
storage temperature to allow the bubbles to dissipate. To minimize
volume depletion, do not use a transfer pipette to remove the bubbles. PROCEDURE
CAUTION: Reagent bubbles may interfere with proper detection of Materials Provided
reagent level in the cartridge, causing insufficient reagent aspiration 7D53 Albumin BCG Reagent Kit
which could impact results.
Materials Required but not Provided
Reagent Storage • 1E65 Multiconstituent Calibrator
Unopened reagents are stable until the expiration date when stored 3 x 5 mL (not required for this assay)
at 15 to 30°C.
3 x 5 mL
Reagent stability is 42 days if the reagent is uncapped and onboard.
• Control Material
WARNINGS AND PRECAUTIONS • Saline (0.85% to 0.90% NaCl) for specimens that require dilution

Precautions for Users Assay Procedure

1. For in vitro diagnostic use.
2. Do not use components beyond the expiration date.
3. Do not mix materials from different kit lot numbers.
4. Contains mercury: Dispose of properly.
5. CAUTION: This product requires the handling of human
specimens. It is recommended that all human sourced
materials be considered potentially infectious and be
handled in accordance with the OSHA Standard on
Bloodborne Pathogens.1 Biosafety Level 22 or other
appropriate biosafety practices3,4 should be used for
materials that contain or are suspected of containing
infectious agents.
For a detailed description of how to run an assay, refer to Section 5 of
the instrument-specific operations manual.
Specimen Dilution Procedures
The ARCHITECT c Systems and the AEROSET System have automatic
dilution features; refer to Section 2 of the instrument-specific operations
manual for additional information.
Serum and Plasma: Specimens with albumin values exceeding
10.5 g/dL (105 g/L) are flagged and may be diluted by following either
the Automated Dilution Protocol or the Manual Dilution Procedure.
Automated Dilution Protocol
If using the Automated Dilution Protocol, the system performs a dilution
of the specimen and automatically corrects the concentration by
multiplying the result by the appropriate dilution factor. To set up the
automatic dilution feature, refer to Section 2 of the instrument-specific
operations manual for additional information.

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PROCEDURE SPECIFIC PERFORMANCE CHARACTERISTICS
Manual Dilution Procedure Linearity
Manual dilutions should be performed as follows: Albumin BCG is linear up to 10.5 g/dL (105 g/L). Linearity was verified
• Use saline (0.85% to 0.90% NaCl) to dilute the sample. using Clinical and Laboratory Standards Institute (CLSI) protocol NCCLS
EP6-P.8
• The operator must enter the dilution factor in the patient or control
order screen. The system uses this dilution factor to automatically Limit of Detection (LOD)
correct the concentration by multiplying the result by the entered The LOD for Albumin BCG is 0.3 g/dL (3.0 g/L). The LOD is the
factor. mean concentration of an analyte-free sample + 2 SD, where
• If the operator does not enter the dilution factor, the result must SD = the pooled, within-run standard deviation of the analyte-free
be multiplied by the appropriate dilution factor before reporting the sample. A study performed on an ARCHITECT c System and the
result. AEROSET System produced an LOD for Albumin BCG of 0.07 g/dL
(0.7 g/L).
NOTE: If a diluted sample result is flagged indicating it is less than the
linear low limit, do not report the result. Rerun using an appropriate Limit of Quantitation (LOQ)
dilution. The LOQ for Albumin BCG is 0.31 g/dL (3.1 g/L). The LOQ is the
For detailed information on ordering dilutions, refer to Section 5 of the analyte concentration at which the CV = 20%.
instrument-specific operations manual.
Interfering Substances
CALIBRATION Interference studies were conducted using CLSI protocol NCCLS EP7-P.9
Calibration is stable for approximately 41 days (984 hours) and is Interference effects were assessed by Dose Response and Paired
required with each change in reagent lot number. Verify calibration Difference methods, at the medical decision level of the analyte.
with at least two levels of controls according to the established quality Interfering Interferent Concentration N Target Observed
control requirements for your laboratory. If control results fall outside Substance (g/dL) (% of Target)
acceptable ranges, recalibration may be necessary.
30 mg/dL (513 μmol/L) 4 4.1 99.1
For a detailed description of how to calibrate an assay, refer to Bilirubin
Section 6 of the instrument-specific operations manual. 60 mg/dL (1,026 μmol/L) 4 4.1 98.5
For information on calibrator standardization, refer to the 750 mg/dL (7.5 g/L) 4 3.9 108.6
Hemoglobin
Multiconstituent Calibrator package insert. 1,000 mg/dL (10 g/L) 4 3.9 111.8
1,000 mg/dL (10 g/L) 4 3.9 109.5
QUALITY CONTROL Intralipid
2,000 mg/dL (20 g/L) 4 3.9 119.1
The following is the recommendation of Abbott Laboratories for quality
control. As appropriate, refer to your laboratory standard operating Bilirubin solutions at the above concentrations were prepared by addition
procedure(s) and/or quality assurance plan for additional quality control of a bilirubin stock to human serum pools. Hemoglobin solutions at
requirements and potential corrective actions. the above concentrations were prepared by addition of hemolysate to
• Two levels of controls (normal and abnormal) are to be run every human serum pools. Intralipid solutions at the above concentrations were
24 hours. prepared by addition of Intralipid to human serum pools.
• If more frequent control monitoring is required, follow the established Interferences from medications or endogenous substances may affect
quality control procedures for your laboratory. results.10
• If quality control results do not meet the acceptance criteria Precision
defined by your laboratory, patient values may be suspect. Follow The imprecision of the Albumin BCG assay is ≤ 3.3% Total CV. Studies
the established quality control procedures for your laboratory. were performed using CLSI protocol NCCLS EP5-A.11 Representative
Recalibration may be necessary. data are summarized below.
• Review quality control results and acceptance criteria following a
change of reagent or calibrator lot. Control Level 1 Level 2
N 80 80
RESULTS Mean (g/dL) 4.1 2.7
Refer to the instrument-specific operations manual for information on
results calculations. SD 0.02 0.01
Within Run
• ARCHITECT System Operations Manual—Appendix C %CV 0.6 0.5
• AEROSET System Operations Manual—Appendix A SD 0.01 0.01
Between Run
Representative performance data are given in the EXPECTED VALUES %CV 0.3 0.5
and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this SD 0.05 0.03
package insert. Results obtained in individual laboratories may vary. Between Day
%CV 1.3 1.3
SD 0.06 0.04
LIMITATIONS OF THE PROCEDURE Total
Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC %CV 1.5 1.4
PERFORMANCE CHARACTERISTICS sections of this package insert. Method Comparison
EXPECTED VALUES Correlation studies were performed using CLSI protocol NCCLS EP9-A.12
Serum results from the Albumin BCG assay on the AEROSET System
Reference Range were compared with those from a commercially available bromcresol
Serum/Plasma7 green methodology.
Serum results from the Albumin BCG assay on an ARCHITECT c System
Range (g/dL) Range (g/L) were compared with the Albumin BCG assay on the AEROSET System.
0 to 4 days 2.8 to 4.4 28 to 44
AEROSET vs. ARCHITECT vs.
4 days to 14 years 3.8 to 5.4 38 to 54
Comparative Method AEROSET
Adult 3.5 to 5.0 35 to 50
N 98 96
> 60 years 3.4 to 4.8 34 to 48
Y - Intercept -0.124 0.179
Average is ≈0.3 g/dL (≈3 g/L) higher in ambulatory individuals. Correlation Coefficient 0.997 1.000
To convert results from g/dL to g/L, multiply g/dL by 10. Slope 1.070 0.961
It is recommended that each laboratory determine its own reference Range (g/dL)* 1.37 to 7.20 2.34 to 10.78
range based upon its particular locale and population characteristics. *AEROSET Range

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BIBLIOGRAPHY
1. US Department of Labor, Occupational Safety and Health
Administration. 29 CFR Part 1910.1030. Bloodborne Pathogens.
2. US Department of Health and Human Services. Biosafety in
Microbiological and Biomedical Laboratories, 5th ed. Washington,
DC: US Government Printing Office, January 2007.
3. World Health Organization. Laboratory Biosafety Manual, 3rd ed.
Geneva: World Health Organization, 2004.
4. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved
Guideline—Third Edition (M29-A3). Wayne, PA: Clinical and
Laboratory Standards Institute, 2005.
5. Guder WG, da Fonseca-Wollheim F, Heil W, et al. The Quality of
Diagnostic Samples. Darmstadt, Germany: GIT Verlag; 2001:14–5.
6. US Pharmacopeial Convention, Inc. General notices. In: US
Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18).
Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11.
7. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical
Chemistry, 2nd ed. Philadelphia, PA: WB Saunders; 1994:2177.
8. Passey RB, Bee DE, Caffo A, et al. Evaluation of the Linearity
of Quantitative Analytical Methods; Proposed Guideline (EP6-P).
Villanova, PA: The National Committee for Clinical Laboratory
Standards, 1986.
9. Powers DM, Boyd JC, Glick MR, et al. Interference Testing in Clinical
Chemistry; Proposed Guideline (EP7-P). Villanova, PA: The National
Committee for Clinical Laboratory Standards, 1986.
10. Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed.
Washington, DC: AACC Press; 1995:3-16–3-22.
11. Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision
Performance of Clinical Chemistry Devices; Approved Guideline
(EP5-A). Wayne, PA: The National Committee for Clinical Laboratory
Standards, 1999.
12. Kennedy JW, Carey RN, Coolen RB, et al. Method Comparison and
Bias Estimation Using Patient Samples; Approved Guideline
(EP9-A). Wayne, PA: The National Committee for Clinical
Laboratory Standards, 1995.

TRADEMARKS
The ARCHITECT c System family of instruments consists of c 4000,
c 8000, and c 16000 instruments.
AEROSET, ARCHITECT, c 4000, c 8000, c 16000, c System, and
SmartWash are trademarks of Abbott Laboratories in various
jurisdictions.
All trademarks are property of their respective owners.

Abbott Laboratories ABBOTT

Abbott Park, IL 60064 USA Max-Planck-Ring 2
65205 Wiesbaden
Germany
304570/R01 +49-6122-580

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ARCHITECT c Systems ASSAY PARAMETERS

Albumin BCG Serum/Plasma—Conventional and SI Units

Configure assay parameters — General Configure assay parameters — SmartWash

● General о Calibration о SmartWash о Results о Interpretation о General о Calibration ● SmartWash о Results о Interpretation
Assay: AlbG Type: Photometric Version: † Assay: AlbG
Number: 1015
COMPONENT REAGENT / ASSAY WASH Volume Replicates
● Reaction definition о Reagent / Sample о Validity checks R1 ALBG0 Water 300 1
Reaction mode: End up
R1 ALKP0 Water 300 1
Primary Secondary Read times
R1 TRIG0 Water 300 1
Wavelength: 628 / 700 Main: 4 – 6
Cuvette Trig 10% Detergent B 345
Last required read: 6
Absorbance range: ___ – ___ Color correction: ___ – ___
Sample blank type: None
Albumin BCG Serum/Plasma—Conventional Units

о Reaction definition ● Reagent / Sample о Validity checks Configure assay parameters — Results
R1
Reagent: ALBG0 Reagent volume: 280 о General о Calibration о SmartWash ● Results о Interpretation
Diluent: Saline Water volume: ___ Assay: AlbG Assay number: 1015
Diluent dispense mode: Type 0 Dispense mode: Type 0 Dilution default range: Result units: g/dL
Low-Linearity: 0.4‡‡
Diluted Default High-Linearity: 10.5
Dilution name Sample sample Diluent Water Dilution factor dilution
Gender and age specific ranges:
STANDARD : 2.4 ___ ___ ___ = 1:1.00 ● GENDER AGE (UNITS) NORMAL EXTREME
_________ : ___ ___ ___ ___ = о Either 0 – 130 (Y) 3.5 – 5.0
_________ : ___ ___ ___ ___ = о
Configure result units
о Reaction definition о Reagent / Sample ● Validity checks
Reaction check: None Assay: AlbG
Version: †
Result units: g/dL
Decimal places: 1 [Range 0 – 4]
Maximum absorbance variation: ___ Correlation factor: 1.0000
Intercept: 0.0000
Configure assay parameters — Calibration
о General ● Calibration о SmartWash о Results о Interpretation Albumin BCG Serum/Plasma—SI Units
Assay: AlbG Calibration method: Linear
Configure assay parameters — Results
● Calibrators о Volumes о Intervals о Validity checks о General о Calibration о SmartWash ● Results о Interpretation
Calibrator set: Calibrator level: Concentration: Assay: AlbG Assay number: 1015
MCC Blank: Water 0†† Dilution default range: Result units: g/L
Cal 1: MCC2 ‡ Low-Linearity: 4‡‡
Replicates: 3 [Range 1 – 3] Cal 2: MCC2 ‡ High-Linearity: 105
Gender and age specific ranges:
о Calibrators ● Volumes о Intervals о Validity checks GENDER AGE (UNITS) NORMAL EXTREME
Calibrator: MCC Diluted Either 0 – 130 (Y) 35 – 50
Dilu-
Calibrator level Sample sample Water
ent
Blank: Water 2.4 ___ ___ ___
Cal 1: MCC2 35.0 2.4 65 ___
Cal 2: MCC2 2.4 ___ ___ ___
Configure result units
Assay: AlbG
о Calibrators о Volumes ● Intervals о Validity checks Version: †
Calibration intervals:
Full interval: 984 (hours) Result units: g/L
Calibration type: Decimal places: 0 [Range 0 – 4]
Adjust type: None Correlation factor: 1.0000
Intercept: 0.0000
о Calibrators о Volumes о Intervals ● Validity checks
Blank absorbance range: _____ – _____
Span: Blank – Blank
Span absorbance range: _____ – _____
Expected cal factor: 0.00
Expected cal factor tolerance %: 0

† Due to differences in instrument systems and unit configurations, version numbers may vary.
†† Displays the number of decimal places defined in the decimal places parameter field.
‡ Refer to the concentration specified on calibrator labeling or value sheet. In ARCHITECT software version 5.00 and above, these values are
defined on the Configure calibrator set screen.
‡‡ The linear low value (Low-Linearity) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.

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AEROSET SYSTEM ASSAY PARAMETERS

Albumin BCG Serum/Plasma—Conventional Units Albumin BCG Serum/Plasma—SI Units

Assay Configuration: Outline Page Assay Configuration: Outline Page

Assay Name Assay # Line Assay Name Assay # Line
AlbG 15 A-Line AlbG 15 A-Line
Quantitative Ranges Quantitative Ranges
Min Text Min Panic-L L-Reference-H Panic-H Max Max Text Min Text Min Panic-L L-Reference-H Panic-H Max Max Text
* 0.0* 0.0 3.5 5.0 0.0 0.0* * * 0.0* 0.0 35 50 0.0 0.0* *
0.4** L-Linear Range-H 10.5 4** L-Linear Range-H 105
Reference Ranges* Reference Ranges*
Age Male Female Age Male Female
0 Year 0.0 – 0.0 0.0 – 0.0 0 Year 0.0 – 0.0 0.0 – 0.0
0.0 – 0.0 0.0 – 0.0 0.0 – 0.0 0.0 – 0.0
0 Year 0 Year
0.0 – 0.0 0.0 – 0.0 0.0 – 0.0 0.0 – 0.0
0 Year 0.0 – 0.0 0.0 – 0.0 0 Year 0.0 – 0.0 0.0 – 0.0
Qualitative Ranges N/A Qualitative Ranges N/A

Assay Configuration: Base Page Assay Configuration: Base Page

Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex AbsMaxVar Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex AbsMaxVar
END UP 628 / 700 4–6/0–0 0.0 END UP 628 / 700 4–6/0–0 0.0
Sample Blank Test Blank Read Time Abs Window Abs Limits Sample Blank Test Blank Read Time Abs Window Abs Limits
_____ ( ___ ) 0–0 0–0 0.0 – 0.0 _____ ( ___ ) 0–0 0–0 0.0 – 0.0
S.Vol DS.Vol D.Vol W.Vol S.Vol DS.Vol D.Vol W.Vol
Standard 2.4 0.0 0 0 Rgt Name/Pos Standard 2.4 0.0 0 0 Rgt Name/Pos
Dil 1 2.4 0.0 0 0 Diluent: DILUENT C-10* Dil 1 2.4 0.0 0 0 Diluent: DILUENT C-10*
Dil 2 2.4 0.0 0 0 Type# 0 Dil 2 2.4 0.0 0 0 Type# 0
Rgt Name/Pos R.Vol W.Vol Type# Rgt Name/Pos R.Vol W.Vol Type#
Reagent 1 ALBG061 – ___* 280 0 0 Reagent 1 ALBG061 – ___* 280 0 0
Reaction Check Read Time – A/B Range Minimum Reaction Check Read Time – A/B Range Minimum
___________ 1–1/1–1 0.0 – 0.0 0.0 ___________ 1–1/1–1 0.0 – 0.0 0.0
Factor/Intercept Decimal Places Units Factor/Intercept Decimal Places Units
1.0 / 0.0 1 g/dL 1.0 / 0.0 0 g/L

Assay Configuration: Calibration Page Assay Configuration: Calibration Page

Calib Mode Interval (H) Calib Mode Interval (H)
Linear 984 Linear 984
Blank/Calib Replicates Extrapolation % Span Span Abs Range Blank/Calib Replicates Extrapolation % Span Span Abs Range
3/3 0 BLK – 1 0.0 – 0.0 3/3 0 BLK – 1 0.0 – 0.0
Sample S.Vol DS.Vol D.Vol W.Vol Blk Abs Range Sample S.Vol DS.Vol D.Vol W.Vol Blk Abs Range
BLK Water 2.4 0.0 0 0 0.0 – 0.0 BLK Water 2.4 0.0 0 0 0.0 – 0.0
C1 MCC2 35.0 2.4 65 0 Cal Deviation C1 MCC2 35.0 2.4 65 0 Cal Deviation
C2 MCC2 2.4 0.0 0 0 0.0 C2 MCC2 2.4 0.0 0 0 0.0
FAC Limit (%) FAC Limit (%)
10 10

Assay Configuration: SmartWash Page Assay Configuration: SmartWash Page

Rgt Probe Rgt Probe
Reagent Wash Vol Reagent Wash Vol
ALBG061 Water 300 ALBG061 Water 300
ALKP061 Water 300 ALKP061 Water 300
TRIG061 Water 300 TRIG061 Water 300
ALKP041 Water 300 ALKP041 Water 300
ALKP051 Water 300 ALKP051 Water 300
Cuvette Cuvette
Assay Name Wash Vol Assay Name Wash Vol
— — — — — —
Sample Probe Sample Probe
Wash Wash
— —

Refer to Assay Configuration in Section 2 of the AEROSET System Operations Manual for information regarding assay parameters.
* User defined or instrument defined.
** The linear low value (L-Linear Range) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.

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