IMMUNOGLOBULIN A

9D98-20
304565/R06

IMMUNOGLOBULIN A
This package insert contains information to run the Immunoglobulin A assay on the ARCHITECT c Systems and the
AEROSET System.

NOTE: Changes Highlighted

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

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Calibrators 1 through 5 Serial number
European Community
Calibrator 1 Ingredients Consult instructions for use

Calibrator 2 In vitro diagnostic medical device Manufacturer

Calibrator 3 Batch code/Lot number Temperature limitation

Calibrator 4 Reagent 1 Use by/Expiration date

Calibrator 5 Reagent 2

Concentration Catalog number/List number

March 2010
©2004, 2010 Abbott Laboratories

1
NAME
IMMUNOGLOBULIN A
INTENDED USE
The Immunoglobulin A (IgA) assay is used for the quantitation of IgA in
human serum or plasma.
SUMMARY AND EXPLANATION OF TEST
Approximately 10% to 15% of serum immunoglobulin is IgA. Serum
IgA is predominantly in a monomeric form with 10% to 15% as a
dimer. Secretory IgA, found in tears, sweat, saliva, milk, colostrum,
and gastrointestinal and bronchial secretions, is synthesized mainly by
plasma cells in gastrointestinal and bronchial mucous membranes and
lactating breast ductules. Secretory IgA is composed of two monomers
linked by a secretory molecule. This secretory component protects the
IgA polymer from proteolytic enzymatic degradation. IgA can initiate
complement activation by the alternative pathway.1 Secretory IgA plays
a major role in the protection of the respiratory, genitourinary, and
gastrointestinal tracts against infection. The specific role of serum IgA
is still unclear; it may be important in virus neutralization.2
Indications for serum IgA quantitation include recurrent infections,
especially of the lower respiratory or gastrointestinal tract; anaphylactic
transfusion reaction; diagnosis of ataxia telangiectasia; differentiation
of M-components in myeloma; and evaluation of progression of IgA
myeloma.2
IgA does not cross the placenta and, as a result, IgA levels in infants’
sera are very low.2 Serum IgA levels do not reach adult concentrations
until 12 years of age.3 Approximately one out of every 700 caucasians
is genetically IgA deficient. Of these individuals, about one-fourth
develop anti-IgA antibodies and are at risk of undergoing severe
anaphylactic reactions to plasma or other blood product transfusions.
Inherited IgA deficiency is also seen in ataxia telangiectasia and in
combined immunodeficiency disorders. Individuals with absent IgA
have a higher than expected incidence of rheumatic disorders and
lymphoma. Secondary IgA deficiency is seen with non-IgA multiple
myeloma or macroglobulinemia, and with nephrotic syndrome.2
Elevated IgA levels are associated with both polyclonal (more than
IgA affected) as well as monoclonal increases. Polyclonal increases
include: chronic liver disease, chronic infections (especially of GI and
respiratory tracts), neoplasia of lower GI tract, inflammatory bowel
disease, and autoimmune diseases such as rheumatoid arthritis.
Monoclonal increases include: IgA multiple myeloma and, occasionally,
other lymphomas.2
PRINCIPLES OF PROCEDURE
The IgA assay is an immunoturbidimetric procedure that measures
increasing sample turbidity caused by the formation of insoluble
immune complexes when antibody to IgA is added to the sample.
Sample containing IgA is incubated with a buffer ( ) and a sample
blank determination is performed prior to the addition of IgA antibody
( ). In the presence of an appropriate antibody in excess, the IgA
concentration is measured as a function of turbidity.
Methodology: Immunoturbidimetric
REAGENTS
Reagent Kit
9D98 Immunoglobulin A is supplied as a liquid, ready-to-use,
two-reagent kit which contains:
4 x 20 mL
4 x 8 mL
Estimated tests per kit: 373
Calculation is based on the minimum reagent fill volume per kit.
Reactive Ingredients Concentration
TRIS 100 mmol/L
Polyethylene Glycol 30 g/L
Sodium Azide 0.1%
Anti-human IgA goat serum 50%
TRIS 100 mmol/L
Sodium Azide 0.1%
2
REAGENT HANDLING AND STORAGE
Reagent Handling
Remove air bubbles, if present in the reagent cartridge, with a new
applicator stick. Alternatively, allow the reagent to sit at the appropriate
storage temperature to allow the bubbles to dissipate. To minimize
volume depletion, do not use a transfer pipette to remove the bubbles.
CAUTION: Reagent bubbles may interfere with proper detection of
reagent level in the cartridge, causing insufficient reagent aspiration
which could impact results.
Reagent Storage
Unopened reagents are stable until the expiration date when stored
at 2 to 8°C.
Reagent onboard stability is approximately 28 days if quality control
results meet acceptance criteria. If quality control results do not meet
acceptance criteria, refer to the QUALITY CONTROL section of this
package insert.
WARNINGS AND PRECAUTIONS
Precautions for Users
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. Do not mix fresh reagent with in-use reagents.
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.4 Biosafety Level 25 or other
appropriate biosafety practices6,7 should be used for materials that
contain or are suspected of containing infectious agents.
6. This product contains sodium azide. For a specific listing, refer to
the REAGENTS section of this package insert. Contact with acids
liberates very toxic gas. This material and its container must be
disposed of in a safe way.
NOTE: Refer to Section 8 of the instrument-specific operations
manual for proper handling and disposal of reagents containing
sodium azide.
For product not classified as dangerous per European Directive
1999/45/EC as amended, safety data sheet available for professional
user on request.
SPECIMEN COLLECTION AND HANDLING
Suitable Specimens
Serum and plasma are acceptable specimens.
• Serum: Use serum collected by standard venipuncture techniques
into glass or plastic tubes with or without gel barriers. Ensure
complete clot formation has taken place prior to centrifugation.
When processing samples, separate serum from blood cells or
gel according to the specimen collection tube manufacturer’s
instructions.
Some specimens, especially those from patients receiving
anticoagulant or thrombolytic therapy, may take longer to complete
their clotting processes. Fibrin clots may subsequently form in these
sera and the clots could cause erroneous test results.
• Plasma: Use plasma collected by standard venipuncture
techniques into glass or plastic tubes. Acceptable anticoagulants
are lithium heparin (with or without gel barrier), sodium heparin,
and EDTA. Ensure centrifugation is adequate to remove platelets.
When processing samples, separate plasma from blood cells or
gel according to the specimen collection tube manufacturer’s
instructions.
For total sample volume requirements, refer to the instrument-specific
ASSAY PARAMETERS section of this package insert and Section 5 of
the instrument-specific operations manual.
SPECIMEN COLLECTION AND HANDLING (Continued)
Specimen Storage
Serum and Plasma: Analyze fresh specimens if possible. Repeated
freeze/thaw cycles should be avoided to minimize potential protein
degradation.
Temperature Maximum Bibliographic
Storage Reference
20 to 25°C 8 months 8 4. Select <OK> to save the settings.
2 to 8°C 8 months 8, 9
-20°C 8 months 8 package insert for IgA Rerun Rules configuration.
Guder et al.8 suggest storage of frozen specimens at -20°C for no longer
than the time interval cited above. However, limitations of laboratory
equipment make it necessary in practice for clinical laboratories to
establish a range around -20°C for specimen storage. This temperature
range may be established from either the freezer manufacturer’s
specifications or your laboratory standard operating procedure(s) for
specimen storage.
NOTE: Stored specimens must be inspected for particulates. If present,
mix and centrifuge the specimen to remove particulates prior to testing.
PROCEDURE
Materials Provided
9D98 Immunoglobulin A Reagent Kit
Materials Required but not Provided
• 1E78 Specific Proteins Multiconstituent Calibrator
1 x 1 mL
• Control Material
• Saline (0.85% to 0.90% NaCl) for specimens that require dilution
Assay Procedure
Due to the genetic heterogeneity of human IgA, its reaction with
antibodies is variable at higher concentrations. This affects the IgA
concentration at which the phenomenon of antigen excess, or prozone,
may be observed. The IgA assay uses a standard 1:5 sample dilution
to avoid antigen excess. Samples with low IgA concentrations are rerun
undiluted.
IgA is analyzed as follows:
• The sample is run using a 1:5 dilution.
• If a patient result flag “<” (ARCHITECT c Systems) or an LL result
error code (AEROSET) is generated, the system can be configured
to automatically rerun the sample undiluted.
Refer to the instrument-specific Configuration instructions that
follow and Section 2 of the instrument-specific operations manual.
• If the system is not configured to automatically rerun the sample,
a rerun must be ordered by the operator using the UNDILUTED
(ARCHITECT c Systems) or Dil 1 (AEROSET) dilution protocol.
For a detailed description of how to run an assay, refer to Section 5 of
the instrument-specific operations manual.
Configuration
To automatically rerun the sample undiluted, perform the following
instrument-specific steps. Refer to Section 2 of the instrument-specific
operations manual for additional information.
ARCHITECT c Systems—Configure Retest Rules
1. Select System from the menu bar, and then select Configuration.
2. Select the Assay settings option.
The Configuration screen - Assay settings - Assay Parameters view
displays.
3. Select Retest rules from the Assay categories list on the
Configuration screen.
4. Select IgA from the Assays list, and then select F6 - Configure.
5. Select Add rule.
6. Enter a name in the Rule name data entry box.
7. Enter the number of replicates in the Replicates data entry box, or
leave as 1.
8. Ensure the Result range option is selected.
• Edit the first Result range data entry box to be blank.
• Enter 25 mg/dL (0.25 g/L) in the second Result range data
entry box.
NOTE: If the reporting units are changed, the Result range values
must be edited with the appropriate conversion factor.
9. Select STD (1:5) as the Original dilution option.
10. Select UNDILUTED as the Retest dilution option.
11. Select Done to return to the Add/edit assay retest rules window.
12. Select Done to save your changes.
3
PROCEDURE (Continued)
AEROSET System—Configure Auto Rerun
1. Select <RUN> in the Action Area of the Main Display. The RUN
OPTIONS screen displays.
2. Select <SysCfg> in the right column of the RUN OPTIONS screen.
The SYSTEM CONFIGURATION screen displays.
3. Select the Auto Rerun option.
Refer to the AEROSET SYSTEM ASSAY PARAMETERS section of this
NOTE: Samples are not automatically returned to the sample arm
unless the Auto Return option is selected on the RUN OPTIONS screen.
NOTE: For AEROSET Software v1.03ER000 or higher, Auto Rerun
is not performed on non-bar code labeled samples; reruns must be
requested manually.
Specimen Dilution Procedures (for samples above the
reportable range)
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: Using the Standard (1:5) sample dilution,
specimens with IgA values exceeding five times the highest calibrator
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 1:10
dilution of the specimen using 1:10 (ARCHITECT c Systems) or Dil 2
(AEROSET) and automatically corrects the concentration by multiplying
the result by the appropriate dilution factor.
Manual Dilution Procedure
Manual dilutions should be performed as follows:
• Use saline (0.85% to 0.90% NaCl) to dilute the sample.
Example: A manual 1:4 dilution performed using the Standard 1:5
dilution will result in a 1:20 diluted sample.
• The operator must enter the manual dilution factor in the patient
or control order screen. The system uses this dilution factor to
automatically correct the concentration by multiplying the result by
the entered factor.
• If the operator does not enter the dilution factor, the result must be
multiplied by the appropriate manual dilution factor before reporting
the result.
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
dilution.
For detailed information on ordering dilutions, refer to Section 5 of the
instrument-specific operations manual.
The patient result flag “>” or error code 1054 (ARCHITECT c Systems)
and EXT, LH, and RCD result error codes (AEROSET) may indicate
antigen excess. Dilute sample and rerun. Samples were tested for
antigen excess up to 6,270 mg/dL (62.70 g/L).
CALIBRATION
The linear high field of the assay parameters must be edited to the
concentration of the highest calibrator specified in the value sheet.
Calibration is stable for approximately 25 days (600 hours) and is
required with each change in reagent lot number. Verify calibration with
at least three levels of controls according to the established quality
control requirements for your laboratory. If control results fall outside
acceptable ranges, recalibration may be necessary.
A multi-point calibration (Spline) curve is generated using Specific
Proteins Multiconstituent Calibrator. The assay is configured to
automatically use a 1:25 dilution of the highest calibrator to create
the lowest non-zero calibrator. Refer to the instrument-specific ASSAY
PARAMETERS section of this package insert.
For a detailed description of how to calibrate an assay, refer to
Section 6 of the instrument-specific operations manual.
For information on calibrator standardization, refer to the Specific
Proteins Multiconstituent Calibrator package insert.
QUALITY CONTROL EXPECTED VALUES (Continued)
The following is the recommendation of Abbott Laboratories for quality A study was conducted using 120 serum samples from volunteers. Data
control. As appropriate, refer to your laboratory standard operating were analyzed as described by Solberg12 and Clinical and Laboratory
procedure(s) and/or quality assurance plan for additional quality control Standards Institute (CLSI) protocol NCCLS C28-A.13 From this study,
requirements and potential corrective actions. 95% of all specimens fell within 87 to 534 mg/dL (0.87 to 5.34 g/L),
• Three levels of quality control are to be run every 24 hours. with samples ranging from 66 to 550 mg/dL (0.66 to 5.50 g/L).
• If more frequent control monitoring is required, follow the It is recommended that each laboratory determine its own reference
established quality control procedures for your laboratory. range based upon its particular locale and population characteristics.
• If quality control results do not meet the acceptance criteria
defined by your laboratory, patient values may be suspect. Follow SPECIFIC PERFORMANCE CHARACTERISTICS
the established quality control procedures for your laboratory. Reportable Range (Accuracy by Recovery)
Recalibration may be necessary.
The IgA assay reportable range is from 5 mg/dL (0.05 g/L) to five times
• Review quality control results and acceptance criteria following a the highest calibrator concentration. Human serum containing a known
change of reagent or calibrator lot. concentration of IgA was diluted with saline and the resulting samples
were analyzed. Observed mean results across the reportable range were
RESULTS within 3 mg/dL (0.03 g/L) or 10%, whichever is greater, of the target
Refer to the instrument-specific operations manual for information on concentrations. Representative data are summarized below.
results calculations. %Recovery = (Observed Mean / Target Concentration) × 100
• ARCHITECT System Operations Manual—Appendix C
• AEROSET System Operations Manual—Appendix A Sample Target Observed Delta* Percent (%)
Representative performance data are given in the EXPECTED VALUES Concentration Mean (mg/dL) Recovery*
and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this (mg/dL) (mg/dL)
package insert. Results obtained in individual laboratories may vary.
1** 1.7 1.9 0.2 112.8
LIMITATIONS OF THE PROCEDURE 2** 3.3 3.6 0.2 106.5
Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC 3** 8.7 9.6 1.0 111.1
PERFORMANCE CHARACTERISTICS sections of this package insert.
4 15.9 15.9 0.0 100.0
The performance characteristics of IgA on an analyzer other than the
ARCHITECT c Systems or AEROSET System must be validated and 5 31.7 33.3 1.6 105.0
verified. 6 95.2 101.8 6.6 106.9
Results from samples containing paraproteins (abnormal monoclonal 7 317.4 323.4 6.0 101.9
antibodies) may incorrectly fall within the reference range. Samples
with elevated total protein concentrations or samples from patients with 8 634.8 690.6 55.8 108.8
suspected paraproteinemia can be screened using other laboratory 9 1,269.5 1,303.7 34.2 102.7
methods such as protein electrophoresis. In addition, analysis of one
or more diluted samples should be performed to ensure that consistent 10 2,539.1 2,578.3 39.2 101.6
results are obtained.10 11 3,173.9 3,145.3 -28.5 99.1
Turbidity and particles in the samples can interfere with the assay.
Therefore, particulate matter should be removed by centrifugation prior * Delta and %Recovery were calculated prior to rounding Target
to running the assay. Concentration and Observed Mean values.
** Run undiluted.
EXPECTED VALUES Limit of Quantitation (LOQ)
Reference Range The LOQ for IgA with undiluted samples is ≤ 3 mg/dL (0.03 g/L). The
LOQ is the analyte concentration at which the CV = 20%. Performance
Serum/Plasma11 studies produced an LOQ of 1.2 mg/dL (0.012 g/L).
Range* (mg/dL) Range* (g/L) Interfering Substances
0 to 3 months Interference studies were conducted using CLSI protocol NCCLS
Male 1 to 34 0.01 to 0.34 EP7-P.14 Interference effects were assessed by Dose Response and
Female 1 to 34 0.01 to 0.34 Paired Difference methods, at the medical decision level of the analyte.
> 3 months to 1 year Medical Decision Level 1
Male 8 to 91 0.08 to 0.91
Female 8 to 91 0.08 to 0.91 Interfering Interferent Concentration N Target Observed
Substance (mg/dL) (% of Target)
> 1 to 12 years
Male 21 to 291 0.21 to 2.91 30 mg/dL (513 μmol/L) 4 81.9 99.5
Female 21 to 282 0.21 to 2.82 Bilirubin
60 mg/dL (1,026 μmol/L) 4 81.9 98.4
> 12 to 60 years
1,000 mg/dL (10.0 g/L) 4 81.5 98.1
Male 63 to 484 0.63 to 4.84 Hemoglobin
Female 65 to 421 0.65 to 4.21 2,000 mg/dL (20.0 g/L) 4 81.5 96.3
> 60 years Human 750 mg/dL (8.5 mmol/L) 4 85.1 98.6
Male 101 to 645 1.01 to 6.45 triglyceride 1,000 mg/dL (11.3 mmol/L) 4 85.1 97.4
Female 69 to 517 0.69 to 5.17
1,000 mg/dL (10.0 g/L) 4 83.1 96.9
* Reference ranges are based on a 90% confidence interval for a large Intralipid
2,000 mg/dL (20.0 g/L) 4 83.1 69.9
North American caucasian population.
To convert results from mg/dL to g/L, multiply mg/dL by 0.01.
NOTE: The reportable range may not be suitable for the reference
range of certain populations. An alternate method should be used for
samples with results below the reportable range.

4
SPECIFIC PERFORMANCE CHARACTERISTICS BIBLIOGRAPHY
(Continued) 1. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical
Chemistry, 2nd ed. Philadelphia, PA: WB Saunders; 1994:678–80,
Interfering Substances (Continued) 686.
Medical Decision Level 2 2. Tietz NW, editor. Clinical Guide to Laboratory Tests, 3rd ed.
Philadelphia, PA: WB Saunders; 1995:354–7.
Interfering Interferent Concentration N Target Observed 3. Henry JB. Clinical Diagnosis and Management by Laboratory
Substance (mg/dL) (% of Target) Methods, 18th ed. Philadelphia, PA: WB Saunders; 1991:820.
30 mg/dL (513 μmol/L) 4 496.3 101.9 4. US Department of Labor, Occupational Safety and Health
Bilirubin Administration. 29 CFR Part 1910.1030. Bloodborne Pathogens.
60 mg/dL (1,026 μmol/L) 4 496.3 98.8
5. US Department of Health and Human Services. Biosafety in
1,000 mg/dL (10.0 g/L) 4 514.7 98.4 Microbiological and Biomedical Laboratories, 5th ed. Washington,
Hemoglobin
2,000 mg/dL (20.0 g/L) 4 514.7 96.0 DC: US Government Printing Office, January 2007.
750 mg/dL (8.5 mmol/L) 4 516.4 89.7 6. World Health Organization. Laboratory Biosafety Manual, 3rd ed.
Human
Geneva: World Health Organization, 2004.
triglyceride 1,000 mg/dL (11.3 mmol/L) 4 516.4 85.4
7. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
1,000 mg/dL (10.0 g/L) 4 459.5 99.5 Workers from Occupationally Acquired Infections; Approved
Intralipid Guideline—Third Edition (M29-A3). Wayne, PA: Clinical and
2,000 mg/dL (20.0 g/L) 4 459.5 88.2
Laboratory Standards Institute, 2005.
Bilirubin solutions at the above concentrations were prepared by 8. Guder WG, da Fonseca-Wollheim F, Heil W, et al. The Quality of
addition of a bilirubin stock to human serum pools. Hemoglobin Diagnostic Samples. Darmstadt, Germany: GIT Verlag; 2001:34–5.
solutions at the above concentrations were prepared by addition 9. US Pharmacopeial Convention, Inc. General notices. In: US
of hemolysate to human serum pools. Human triglyceride solutions Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18).
at the above concentrations were prepared by mixing an elevated Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11.
triglyceride human serum pool with a normal triglyceride human serum
pool. Intralipid solutions at the above concentrations were prepared by 10. Ledue TB, Collins MF, Ritchie RF. Development of
addition of Intralipid to human serum pools. immunoturbidimetric assays for fourteen human serum proteins on
the Hitachi 912. Clin Chem Lab Med 2002;40(5):520–8.
Precision 11. Ritchie RF, editor. Serum Proteins in Clinical Medicine, Vol 1. AACC,
The imprecision of the IgA assay is ≤ 4.1% Total CV. Representative 1996:11.01-13.
data from studies using CLSI protocol NCCLS EP5-A15 are summarized 12. Solberg HE. Establishment and Use of Reference Values. In: Burtis
below. CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry, 2nd
ed. Philadelphia, PA: WB Saunders; 1994:454–84.
Control Level 1 Level 2 Level 3
13. Sasse EA, Aziz KJ, Harris EK, et al. How to Define and Determine
N 80 80 80 Reference Intervals in the Clinical Laboratory; Approved Guideline
Mean (mg/dL) 104.4 206.9 307.7 (C28-A). Villanova, PA: The National Committee for Clinical
Laboratory Standards, 1995.
SD 1.22 2.15 2.56 14. Powers DM, Boyd JC, Glick MR, et al. Interference Testing in
Within Run
%CV 1.2 1.0 0.8 Clinical Chemistry; Proposed Guideline (EP7-P). Villanova, PA: The
National Committee for Clinical Laboratory Standards, 1986.
SD 0.59 1.79 2.48 15. Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision
Between Run
%CV 0.6 0.9 0.8 Performance of Clinical Chemistry Devices; Approved Guideline
(EP5-A). Wayne, PA: The National Committee for Clinical
SD 0.35 0.00 1.61 Laboratory Standards, 1999.
Between Day
%CV 0.3 0.0 0.5 16. Kennedy JW, Carey RN, Coolen RB, et al. Method Comparison
and Bias Estimation Using Patient Samples; Approved Guideline
SD 1.40 2.79 3.91 (EP9-A). Wayne, PA: The National Committee for Clinical
Total
%CV 1.3 1.4 1.3 Laboratory Standards, 1995.

Method Comparison TRADEMARKS

Correlation studies were performed using CLSI protocol NCCLS The ARCHITECT c System family of instruments consists of c 4000,
EP9-A.16 c 8000, and c 16000 instruments.
Serum results from the IgA assay on the AEROSET System were AEROSET, ARCHITECT, c 4000, c 8000, c 16000, c System, and
compared with those from a commercially available immunoturbidimetric SmartWash are trademarks of Abbott Laboratories in various
methodology. jurisdictions.
Serum results from the IgA assay on an ARCHITECT c System were All trademarks are property of their respective owners.
compared with the IgA assay on the AEROSET System.
AEROSET vs. ARCHITECT
Comparative Method vs. AEROSET
N 87 101
Y - Intercept -5.45 7.41
Correlation Coefficient 0.998 1.000
Slope 1.05 0.99
Mean %Bias 1.8 2.5
Range (mg/dL) 17.0 to 518.6 18.3 to 3,351.4

Abbott Laboratories ABBOTT

Abbott Park, IL 60064 USA Max-Planck-Ring 2
65205 Wiesbaden
Germany
304565/R06 +49-6122-580

5
ARCHITECT c SYSTEMS ASSAY PARAMETERS

Immunoglobulin A 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: IgA Type: Photometric Version: † Assay: IgA
Number: 1057
COMPONENT REAGENT / ASSAY WASH Volume Replicates
● Reaction definition о Reagent / Sample о Validity checks Cuvette Trig 10% Detergent B 345
Reaction mode: End up
Primary Secondary Read times
Wavelength: 700 / None Main: 31 – 33 Immunoglobin A Serum/Plasma—Conventional Units
Last required read: 33
Absorbance range: ___ – ___ Color correction: ___ – ___
Sample blank type: Self Blank: 14 – 16 Configure assay parameters — Results
о General о Calibration о SmartWash ● Results о Interpretation
Assay: IgA Assay number: 1057
о Reaction definition ● Reagent / Sample о Validity checks Dilution default range: Result units: mg/dL
R1 R2
Low-Linearity: 5
Reagent: IGA00 Reagent volume: 167 47
High-Linearity: 630§
Diluent: Saline Water volume: ___ ___
Gender and age specific ranges:*
Diluent dispense mode: Type 0 Dispense mode: Type 0 Type 0
GENDER AGE (UNITS) NORMAL** EXTREME
Diluted Default Male 0 – 130 (Y) 63 – 484
Dilution name Sample sample Diluent Water Dilution factor dilution
Female 0 – 130 (Y) 65 – 421
STD (1:5) : 20.0 6.5 80 ___ = 1:5.00 ● Either 0 – 130 (Y) 63 – 484
UNDILUTED : 6.5 ___ ___ ___ = 1:1.00 о
1:10 : 10.0 6.5 90 ___ = 1:10.00 о
Configure result units
о Reaction definition о Reagent / Sample ● Validity checks Assay: IgA
Reaction check: Rate Subtraction Version: †
A B Result units: mg/dL
Read Time: 29 – 33 11 – 15 Decimal places: 0 [Range 0 – 4]
Calculation limits: -0.1000 – 0.0200 Correlation factor: 1.0000
Maximum absorbance variation: ___ Intercept: 0.0000

Configure assay parameters — Calibration Immunoglobin A Serum/Plasma—SI Units

о General ● Calibration о SmartWash о Results о Interpretation
Assay: IgA Calibration method: Spline 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: IgA Assay number: 1057
SP Blank: Water 0‡ Dilution default range: Result units: g/L
Cal 1: SP5†† ‡‡ Value from Low-Linearity: 0.05
Replicates: 3 [Range 1 – 3] Cal 2: SP1 ‡‡ Value from High-Linearity: 6.30§
Cal 3: SP2 ‡‡ Value from Gender and age specific ranges:*
Cal 4: SP3 ‡‡ Value from GENDER AGE (UNITS) NORMAL** EXTREME
Cal 5: SP4 ‡‡ Value from Male 0 – 130 (Y) 0.63 – 4.84
Cal 6: SP5 ‡‡ Value from Female 0 – 130 (Y) 0.65 – 4.21
Either 0 – 130 (Y) 0.63 – 4.84
о Calibrators ● Volumes о Intervals о Validity checks
Calibrator: SP Diluted Configure result units
Calibrator level Sample sample Diluent Water
Assay: IgA
Blank: Water 6.5 ___ ___ ___
Version: †
Cal 1: SP5†† 4.0 6.5 96 ___
Result units: g/L
Cal 2: SP1 6.5 ___ ___ ___
Decimal places: 2 [Range 0 – 4]
Cal 3: SP2 6.5 ___ ___ ___
Correlation factor: 1.0000
Cal 4: SP3 6.5 ___ ___ ___
Intercept: 0.0000
Cal 5: SP4 6.5 ___ ___ ___
Cal 6: SP5 6.5 ___ ___ ___

о Calibrators о Volumes
Calibration intervals:
Full interval: 600
Calibration type:
Adjust type: None
о Calibrators о Volumes
Blank absorbance range:
Span:
Span absorbance range:
Expected cal factor:
Expected cal factor tolerance %:
* User defined.
● Intervals о Validity checks ** Reference range is from > 12 years to 60 years of age.
(hours) † Due to differences in instrument systems and unit configurations,
version numbers may vary.
†† Instrument automatically dilutes SP5 for use as Cal 1.
‡ Displays the number of decimal places defined in the decimal
о Intervals ● Validity checks places parameter field.
_____ – _____
‡‡ Refer to the concentration specified in the calibrator value sheet.
Blank – Blank In ARCHITECT software version 5.00 and above, these values are
_____ – _____ defined on the Configure calibrator set screen.
0.00
0 § Edit to highest calibrator concentration specified in the calibrator
value sheet.

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AEROSET SYSTEM ASSAY PARAMETERS

Immunoglobulin A Serum/Plasma—Conventional Units Immunoglobulin A Serum/Plasma—SI Units

Assay Configuration: Outline Page Assay Configuration: Outline Page
Assay Name Assay # Line Assay Name Assay # Line
IgA 57 A-Line IgA 57 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 63 484 0.0 0.0* * * 0.0* 0.0 0.63 4.84 0.0 0.0* *
5 L-Linear Range-H 630§ 0.05 L-Linear Range-H 6.30§
Reference Ranges* Reference Ranges*
Age Male Female Age Male Female
0 Year 63 – 484 65 – 421 0 Year 0.63 – 4.84 0.65 – 4.21
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 700 / ___ 31 – 33 / 0 – 0 0.0 END UP 700 / ___ 31 – 33 / 0 – 0 0.0
Sample Blank Test Blank Read Time Abs Window Abs Limits Sample Blank Test Blank Read Time Abs Window Abs Limits
IgA ( 57 ) 14 – 16 0–0 0.0 – 0.0 IgA ( 57 ) 14 – 16 0–0 0.0 – 0.0
S.Vol DS.Vol D.Vol W.Vol S.Vol DS.Vol D.Vol W.Vol
Standard 20.0 6.5 80 0 Rgt Name/Pos Standard 20.0 6.5 80 0 Rgt Name/Pos
Dil 1 6.5 0.0 0 0 Diluent: DILUENT C–10* Dil 1 6.5 0.0 0 0 Diluent: DILUENT C–10*
Dil 2 10.0 6.5 90 0 Type# 0 Dil 2 10.0 6.5 90 0 Type# 0
Rgt Name/Pos R.Vol W.Vol Type# Rgt Name/Pos R.Vol W.Vol Type#
Reagent 1 IGA0011 – ___* 167 0 0 Reagent 1 IGA0011 – ___* 167 0 0
Reagent 2 IGA0012 – ___* 47 0 0 Reagent 2 IGA0012 – ___* 47 0 0
Reaction Check Read Time – A/B Range Minimum Reaction Check Read Time – A/B Range Minimum
RATE SUB 29 – 33 / 11 – 15 -0.1 – 0.02 0.0 RATE SUB 29 – 33 / 11 – 15 -0.1 – 0.02 0.0
Factor/Intercept Decimal Places Units Factor/Intercept Decimal Places Units
1.0 / 0.0 0 mg/dL 1.0 / 0.0 2 g/L

Assay Configuration: Calibration Page Assay Configuration: Calibration Page

Calib Mode Interval (H) Calib Mode Interval (H)
Spline 600 Spline 600
Blank/Calib Replicates Extrapolation % Span Span Abs Range Blank/Calib Replicates Extrapolation % Span Span Abs Range
3/3 1 BLK – 1 0.0 – 0.0 3/3 1 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 6.5 0.0 0 0 0.0 – 0.0 BLK Water 6.5 0.0 0 0 0.0 – 0.0
C1 SP 5†† 4.0 6.5 96 0 Cal Deviation C1 SP 5†† 4.0 6.5 96 0 Cal Deviation
C2 SP 1 6.5 0.0 0 0 0.0 C2 SP 1 6.5 0.0 0 0 0.0
C3 SP 2 6.5 0.0 0 0 FAC Limit (%) C3 SP 2 6.5 0.0 0 0 FAC Limit (%)
C4 SP 3 6.5 0.0 0 0 10 C4 SP 3 6.5 0.0 0 0 10
C5 SP 4 6.5 0.0 0 0 C5 SP 4 6.5 0.0 0 0
C6 SP 5 6.5 0.0 0 0 C6 SP 5 6.5 0.0 0 0

Assay Configuration: SmartWash Page Assay Configuration: SmartWash Page

Rgt Probe Rgt Probe
Reagent Wash Vol Reagent Wash Vol
— — — — — —
Cuvette Cuvette
Assay Name Wash Vol Assay Name Wash Vol
— — — — — —
Sample Probe Sample Probe
Wash Wash
— —

Assay Configuration: Rerun Rules Page Assay Configuration: Rerun Rules Page
LL : Linear Low Dil 1 LL : Linear Low Dil 1

Refer to Assay Configuration in Section 2 of the AEROSET System Operations Manual for information regarding assay parameters.
* User defined or instrument defined.
** Reference range is from > 12 years to 60 years of age.
§ Edit to highest calibrator concentration specified in the calibrator value sheet.
†† Instrument automatically dilutes SP 5 for use as C1.

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