IMMUNOGLOBULIN M

1E01-20
30-3962/R3

IMMUNOGLOBULIN M
This package insert contains information to run the Immunoglobulin M 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

Calibrators 1 through 5 Catalog number/List number

Concentration Serial number

Authorized Representative in the
Consult instructions for use
European Community
Ingredients Manufacturer

In vitro diagnostic medical device Temperature limitation

Batch code/Lot number Use by/Expiration date

Reagent 1

Reagent 2

December 2009
©2004, 2009 Abbott Laboratories

1
NAME REAGENT HANDLING AND STORAGE (Continued)
IMMUNOGLOBULIN M Reagent Storage
Unopened reagents are stable until the expiration date when stored
INTENDED USE at 2 to 8°C.
The Immunoglobulin M (IgM) assay is used for the quantitation of IgM in Reagent onboard stability is approximately 57 days if quality control
human serum or plasma. results meet acceptance criteria. If quality control results do not meet
acceptance criteria, refer to the QUALITY CONTROL section of this
SUMMARY AND EXPLANATION OF TEST package insert.
IgM, primarily present as a pentamer, is the first immunoglobulin class
produced during an initial immune response and antigen-IgM complexes WARNINGS AND PRECAUTIONS
actively fix complement. The large molecular size of the pentamer
enables direct cross-linking and agglutination of particulate and cellular
Precautions for Users
antigens. Because IgM is involved in primary immune response, 1. For in vitro diagnostic use.
presence of IgM is useful in assessing whether a particular infection 2. Do not use components beyond the expiration date.
is acute (IgM present) or chronic (IgG predominate class present). 3. Do not mix materials from different kit lot numbers.
Additionally, IgM is the first immunoglobulin class to be synthesized by a 4. Do not mix fresh reagent with in-use reagents.
fetus or newborn and IgM antibodies do not cross the placenta.1 5. CAUTION: This product requires the handling of human specimens.
Polyclonal IgM increases may indicate a viral infection, such as It is recommended that all human sourced materials be considered
viral hepatitis or infectious mononucleosis, or the early response to potentially infectious and be handled in accordance with the OSHA
bacterial or parasitic infection. Levels are often increased in rheumatoid Standard on Bloodborne Pathogens.3 Biosafety Level 24 or other
arthritis, chronic hepatocellular disease, and other chronic disorders. appropriate biosafety practices5,6 should be used for materials that
Elevated levels are also seen with hyper-IgM dysgammaglobulinemia, contain or are suspected of containing infectious agents.
active sarcoidosis, collagen vascular disease, and nephrotic 6. This product contains sodium azide. For a specific listing, refer to the
syndrome. Monoclonal IgM increases are seen in Waldenstrom’s REAGENTS section. Contact with acids liberates very toxic gas. This
macroglobulinemia, malignant lymphoma, reticulosis, and cold agglutinin material and its container must be disposed of in a safe way.
hemolysis disease. Small IgM monoclonal bands can accompany a NOTE: Refer to Section 8 of the instrument-specific operations
variety of neoplasms, particularly of the GI tract.2 manual for proper handling and disposal of reagents containing
sodium azide.
Decreased IgM levels are usually not due to primary IgM deficiency.
Secondary IgM deficiency may be associated with IgA or IgG For product not classified as dangerous per European Directive
1999/45/EC as amended, safety data sheet available for professional
type multiple myeloma, protein-losing enteropathies, burns, or
user on request.
immunosuppressive therapy.2 IgM deficiency is associated with
increased, recurrent infections.1
SPECIMEN COLLECTION AND HANDLING
PRINCIPLES OF PROCEDURE Suitable Specimens
The IgM assay is an immunoturbidimetric procedure that measures Serum and plasma are acceptable specimens.
increasing sample turbidity caused by the formation of insoluble • Serum: Use serum collected by standard venipuncture techniques
immune complexes when antibody to IgM is added to the sample. into glass or plastic tubes with or without gel barriers. Ensure
Sample containing IgM is incubated with a buffer ( ) and a sample complete clot formation has taken place prior to centrifugation.
blank determination is performed prior to the addition of IgM antibody When processing samples, separate serum from blood cells or
( ). In the presence of an appropriate antibody in excess, the IgM gel according to the specimen collection tube manufacturer’s
concentration is measured as a function of turbidity. instructions.
Methodology: Immunoturbidimetric Some specimens, especially those from patients receiving
anticoagulant or thrombolytic therapy, may take longer to complete
REAGENTS their clotting processes. Fibrin clots may subsequently form in these
sera and the clots could cause erroneous test results.
Reagent Kit
• Plasma: Use plasma collected by standard venipuncture
1E01 Immunoglobulin M is supplied as a liquid, ready-to-use, techniques into glass or plastic tubes. Acceptable anticoagulants
two-reagent kit which contains: are lithium heparin (with or without gel barrier), sodium heparin,
4 x 20 mL and EDTA. Ensure centrifugation is adequate to remove platelets.
4 x 8 mL When processing samples, separate plasma from blood cells or
gel according to the specimen collection tube manufacturer’s
Estimated tests per kit: 373 instructions.
Calculation is based on the minimum reagent fill volume per kit. For total sample volume requirements, refer to the instrument-specific
ASSAY PARAMETERS section of this package insert and Section 5 of
Reactive Ingredients Concentration the instrument-specific operations manual.
TRIS 100 mmol/L Specimen Storage
Polyethylene Glycol 25 g/L Serum and plasma: Analyze fresh specimens if possible. Repeated
freeze/thaw cycles should be avoided to minimize potential protein
Sodium Azide 0.1% degradation.
Anti-human IgM goat serum 30% Temperature Maximum Bibliographic
TRIS 100 mmol/L Storage Reference
Sodium Azide 0.1% 20 to 25°C 2 months 7
2 to 8°C 4 months 7, 8
-20°C 6 months 7
REAGENT HANDLING AND STORAGE Guder et al.7 suggest storage of frozen specimens at -20°C for
Reagent Handling no longer than the time interval cited above. However, limitations
Remove air bubbles, if present in the reagent cartridge, with a new of laboratory equipment make it necessary in practice for clinical
applicator stick. Alternatively, allow the reagent to sit at the appropriate laboratories to establish a range around -20°C for specimen storage.
storage temperature to allow the bubbles to dissipate. To minimize This temperature range may be established from either the freezer
volume depletion, do not use a transfer pipette to remove the bubbles. manufacturer’s specifications or your laboratory standard operating
procedure(s) for specimen storage.
CAUTION: Reagent bubbles may interfere with proper detection of NOTE: Stored specimens must be inspected for particulates. If present,
reagent level in the cartridge, causing insufficient reagent aspiration mix and centrifuge the specimen to remove particulates prior to testing.
which could impact results.

2
PROCEDURE Specimen Dilution Procedures (for samples above the
Materials Provided reportable range)
The ARCHITECT c Systems and the AEROSET System have automatic
1E01 Immunoglobulin M Reagent Kit
dilution features; refer to Section 2 of the instrument-specific operations
Materials Required but not Provided manual for additional information.
• 1E78 Specific Proteins Multiconstituent Calibrator Serum and plasma: Using the Standard (1:5) sample dilution,
1 x 1 mL specimens with IgM values exceeding five times the highest calibrator
• Control Material are flagged and may be diluted using the Automated Dilution Protocol
or the Manual Dilution Procedure.
• Saline (0.85% to 0.90% NaCl) for specimens that require dilution
Assay Procedure Automated Dilution Protocol
Due to the genetic heterogeneity of human IgM, its reaction with If using the Automated Dilution Protocol, the system performs a 1:10
antibodies is variable at higher concentrations. This affects the IgM dilution of the specimen using 1:10 (ARCHITECT c Systems) or Dil 2
concentration at which the phenomenon of antigen excess, or prozone, (AEROSET) and automatically corrects the concentration by multiplying
may be observed. The IgM assay uses a standard 1:5 sample dilution the result by the appropriate dilution factor.
to avoid antigen excess. Samples with low IgM concentrations are rerun Manual Dilution Procedure
undiluted. Manual dilutions should be performed as follows:
IgM is analyzed as follows: • Use saline (0.85% to 0.90% NaCl) to dilute the sample.
• The sample is run using a 1:5 dilution. Example: A manual 1:4 dilution performed using the Standard 1:5
• If the patient result flag “<” (ARCHITECT c Systems) or an LL result dilution will result in a 1:20 diluted sample.
error code (AEROSET) is generated, the system can be configured to
• The operator must enter the manual dilution factor in the patient
automatically rerun the sample undiluted.
or control order screen. The system uses this dilution factor to
Refer to the instrument-specific Configuration instructions that follow automatically correct the concentration by multiplying the result by
and Section 2 of the instrument-specific operations manual. the entered factor.
• If the system is not configured to automatically rerun the sample, • If the operator does not enter the dilution factor, the result must be
a rerun must be ordered by the operator using the UNDILUTED multiplied by the appropriate manual dilution factor before reporting
(ARCHITECT c Systems) or Dil 1 (AEROSET) dilution protocol. the result.
For a detailed description of how to run an assay, refer to Section 5 of NOTE: If a diluted sample result is flagged indicating it is less than the
the instrument-specific operations manual. linear low limit, do not report the result. Rerun using an appropriate
Configuration dilution.
To automatically rerun the sample undiluted, perform the following For detailed information on ordering dilutions, refer to Section 5 of the
instrument-specific steps. Refer to Section 2 of the instrument-specific instrument-specific operations manual.
operations manual for additional information. The patient result flag “>” or error code 1054 (ARCHITECT c Systems)
and EXT, LH, and RCD result error codes (AEROSET) may indicate
ARCHITECT c Systems—Configure Retest Rules antigen excess. Dilute sample and rerun. Samples were tested for
1. Select System from the menu bar, and then select Configuration. antigen excess up to 7,005 mg/dL (70.05 g/L).
2. Select the Assay settings option.
The Configuration screen - Assay settings - Assay Parameters view CALIBRATION
displays. The linear high field of the assay parameters must be edited to the
3. Select Retest rules from the Assay categories list on the concentration of the highest calibrator specified in the value sheet.
Configuration screen. Calibration is stable for approximately 57 days (1,368 hours) and is
4. Select IgM from the Assays list, and then select F6 - Configure. required with each change in reagent lot number. Verify calibration with
5. Select Add rule. at least three levels of controls according to the established quality
6. Enter a name in the Rule name data entry box. control requirements for your laboratory. If control results fall outside
acceptable ranges, recalibration may be necessary.
7. Enter the number of replicates in the Replicates data entry box, or
leave as 1. A multi-point calibration (Spline) curve is generated using Specific
8. Ensure the Result range option is selected. Proteins Multiconstituent Calibrator.
• Edit the first Result range data entry box to be blank. For a detailed description of how to calibrate an assay, refer to
Section 6 of the instrument-specific operations manual.
• Enter 25 mg/dL (0.25 g/L) in the second Result range data
entry box. For information on calibrator standardization, refer to the Specific
NOTE: If the reporting units are changed, the Result range values must Proteins Multiconstituent Calibrator package insert.
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.
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.
4. Select <OK> to save the settings.
Refer to the AEROSET SYSTEM ASSAY PARAMETERS section of this
package insert for IgM Rerun Rules configuration.
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.

3
QUALITY CONTROL SPECIFIC PERFORMANCE CHARACTERISTICS
The following is the recommendation of Abbott Laboratories for quality Reportable Range (Accuracy by Recovery)
control. As appropriate, refer to your laboratory standard operating
procedure(s) and/or quality assurance plan for additional quality control The IgM assay reportable range is from 5 mg/dL (0.05 g/L) to five times
requirements and potential corrective actions. the highest calibrator concentration. Human serum containing a known
concentration of IgM was diluted with saline and the resulting samples
• Three levels of quality control are to be run every 24 hours were analyzed. Observed mean results across the reportable range
• Run three levels of quality control with each cartridge change. were within 5 mg/dL (0.05 g/L) or 10%, whichever is greater, of the
• If more frequent control monitoring is required, follow the established target concentrations. Representative data are summarized below.
quality control procedures for your laboratory. %Recovery = (Observed Mean / Target Concentration) × 100
• If quality control results do not meet the acceptance criteria
defined by your laboratory, patient values may be suspect. Follow Sample Target Observed Delta* Percent (%)
the established quality control procedures for your laboratory. Concentration Mean (mg/dL) Recovery*
Recalibration may be necessary. (mg/dL) (mg/dL)
• Review quality control results and acceptance criteria following a 1** 3.2 2.9 -0.3 89.2
change of reagent or calibrator lot. 2** 4.2 4.5 0.3 108.3
3** 9.6 9.4 -0.2 98.0
RESULTS
4 21.2 21.8 0.6 102.8
Refer to the instrument-specific operations manual for information on
results calculations. 5 49.0 47.6 -1.4 97.1
• ARCHITECT System Operations Manual—Appendix C 6 81.7 81.7 0.0 100.1
• AEROSET System Operations Manual—Appendix A 7 326.6 313.3 -13.3 95.9
Representative performance data are given in the EXPECTED VALUES 8 653.2 628.8 -24.4 96.3
and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this 9 979.8 945.1 -34.6 96.5
package insert. Results obtained in individual laboratories may vary.
10 1,306.4 1,269.9 -36.5 97.2
LIMITATIONS OF THE PROCEDURE 11 1,633.0 1,591.1 -41.9 97.4
Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC * Delta and %Recovery were calculated prior to rounding Target
PERFORMANCE CHARACTERISTICS sections of this package insert. Concentration and Observed Mean values.
The performance characteristics of IgM on an analyzer other than the ** Run undiluted.
ARCHITECT c Systems or AEROSET System must be validated and
verified. Limit of Quantitation
Results from samples containing paraproteins (abnormal monoclonal The LOQ for IgM is ≤ 2 mg/dL (0.02 g/L). The LOQ is the analyte
antibodies) may incorrectly fall within the reference range. Samples concentration at which the CV = 20%. Performance studies produced
with elevated total protein concentrations or samples from patients with an LOQ of 1.0 mg/dL (0.010 g/L).
suspected paraproteinemia can be screened using other laboratory Interfering Substances
methods such as protein electrophoresis. In addition, analysis of one Interference studies were conducted using CLSI protocol NCCLS
or more diluted samples should be performed to ensure that consistent EP7-P.12 Interference effects were assessed by Dose Response and
results are obtained.9 Paired Difference methods, at two medical decision levels of the
Turbidity and particles in the samples can interfere with the assay. analyte.
Therefore, particulate matter should be removed by centrifugation prior
to running the assay. Medical Decision Level 1
Interfering Interferent Concentration N Target Observed
EXPECTED VALUES Substance (mg/dL) (% of Target)
Reference Range 30 mg/dL (513 μmol/L) 4 50.8 109.79
Bilirubin
Serum/Plasma10 60 mg/dL (1,026 μmol/L) 4 50.8 108.00
Range* (mg/dL) Range* (g/L) 250 mg/dL (2.5 g/L) 4 53.9 92.28
Hemoglobin
Newborn 500 mg/dL (5.0 g/L) 4 53.9 88.20
Male 6 to 21 0.06 to 0.21 Human 750 mg/dL (8.5 mmol/L) 4 62.2 100.33
Female 6 to 21 0.06 to 0.21 triglyceride 1,000 mg/dL (11.3 mmol/L) 4 62.2 100.44
3 months to 1 year 1,000 mg/dL (10.0 g/L) 4 47.7 97.80
Intralipid
Male 17 to 143 0.17 to 1.43 2,000 mg/dL (20.0 g/L) 4 47.7 85.37
Female 17 to 150 0.17 to 1.50
> 1 to 12 years Medical Decision Level 2
Male 41 to 183 0.41 to 1.83 Interfering Interferent Concentration N Target Observed
Female 47 to 240 0.47 to 2.40 Substance (mg/dL) (% of Target)
> 12 years 30 mg/dL (513 μmol/L) 4 270.6 99.64
Male 22 to 240 0.22 to 2.40 Bilirubin
60 mg/dL (1,026 μmol/L) 4 270.6 98.33
Female 33 to 293 0.33 to 2.93
1,000 mg/dL (10.0 g/L) 4 223.9 96.89
* Reference ranges are based on a 90% confidence interval for a Hemoglobin
2,000 mg/dL (20.0 g/L) 4 223.9 95.20
large North American caucasian population.
To convert results from mg/dL to g/L, multiply mg/dL by 0.01. Human 750 mg/dL (8.5 mmol/L) 4 290.5 101.81
Confirmation of the reference ranges for individuals > 12 years of age triglyceride 1,000 mg/dL (11.3 mmol/L) 4 290.5 101.83
was conducted using serum samples from 25 males and 52 females, 1,000 mg/dL (10.0 g/L) 4 275.6 99.65
based on Clinical and Laboratory Standards Institute (CLSI) protocol Intralipid
NCCLS C28-A2.11 2,000 mg/dL (20.0 g/L) 4 275.6 95.14
It is recommended that each laboratory determine its own reference Bilirubin solutions at the above concentrations were prepared by
range based upon its particular locale and population characteristics. addition of a bilirubin stock to human serum pools. Hemoglobin
solutions at the above concentrations were prepared by addition
of hemolysate to human serum pools. Human triglyceride solutions
at the above concentrations were prepared by mixing an elevated
triglyceride human serum pool with a normal triglyceride human serum
pool. Intralipid solutions at the above concentrations were prepared by
addition of Intralipid to human serum pools.

4
SPECIFIC PERFORMANCE CHARACTERISTICS BIBLIOGRAPHY
(Continued) 1. Jacobs DS, DeMott WR, Grady HJ, et al. Laboratory Test Handbook,
4th ed. Hudson, OH: Lexi-Comp; 1996:410.
Precision
The imprecision of the IgM assay is ≤ 4.4% Total CV. Representative 2. Tietz NW, editor. Clinical Guide to Laboratory Tests, 3rd ed.
data from studies using CLSI protocol NCCLS EP5-A13 are summarized Philadelphia, PA: WB Saunders; 1995:360–3.
below. 3. US Department of Labor, Occupational Safety and Health
Administration. 29 CFR Part 1910.1030. Bloodborne Pathogens.
Control Level 1 Level 2 Level 3 4. US Department of Health and Human Services. Biosafety in
N 80 80 80 Microbiological and Biomedical Laboratories, 5th ed. Washington,
DC: US Government Printing Office, January 2007.
Mean (mg/dL) 50.1 135.9 187.3
5. World Health Organization. Laboratory Biosafety Manual, 3rd ed.
SD 1.24 2.19 3.41 Geneva: World Health Organization, 2004.
Within Run
%CV 2.5 1.6 1.8 6. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
SD 0.50 0.80 0.76 Workers from Occupationally Acquired Infections; Approved
Between Run Guideline—Third Edition (M29-A3). Wayne, PA: Clinical and
%CV 1.0 0.6 0.4
Laboratory Standards Institute, 2005.
SD 0.20 0.00 1.65
Between Day 7. Guder WG, da Fonseca-Wollheim F, Heil W, et al. The Quality of
%CV 0.4 0.0 0.9 Diagnostic Samples. Darmstadt, Germany: GIT Verlag; 2001:34–5.
SD 1.35 2.33 3.86 8. US Pharmacopeial Convention, Inc. General notices. In: US
Total
%CV 2.7 1.7 2.1 Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18).
Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11.
Method Comparison 9. Ledue TB, Collins MF, Ritchie RF. Development of
Correlation studies were performed using CLSI protocol NCCLS immunoturbidimetric assays for fourteen human serum proteins on
EP9-A.14 the Hitachi 912. Clin Chem Lab Med 2002;40(5):520–8.
Serum results from the IgM assay on the AEROSET System were 10. Ritchie RF, editor. Serum Proteins in Clinical Medicine, Vol 1. AACC,
compared with those from a commercially available immunoturbidimetric 1996:11.01-14.
methodology.
11. Sasse EA, Doumas BT, Miller WG, et al. How to Define and
Serum results from the IgM assay on an ARCHITECT c System were Determine Reference Intervals in the Clinical Laboratory; Approved
compared with the IgM assay on the AEROSET System. Guideline—Second Edition (C28-A2). Wayne, PA: The National
Committee for Clinical Laboratory Standards, 2000.
AEROSET vs. ARCHITECT
12. Powers DM, Boyd JC, Glick MR, et al. Interference Testing in
Comparative Method vs. AEROSET Clinical Chemistry; Proposed Guideline (EP7-P). Villanova, PA: The
N 78 93 National Committee for Clinical Laboratory Standards, 1986.
13. Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision
Y - Intercept 5.24 -2.18 Performance of Clinical Chemistry Devices; Approved Guideline
Correlation Coefficient 0.998 1.000 (EP5-A). Wayne, PA: The National Committee for Clinical
Slope 1.04 0.96 Laboratory Standards, 1999.
14. Kennedy JW, Carey RN, Coolen RB, et al. Method Comparison
Mean %Bias 9.2 -6.8 and Bias Estimation Using Patient Samples; Approved Guideline
Range (mg/dL) 10.2 to 244.4 14.2 to 1,698.8 (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
30-3962/R3 +49-6122-580

5
ARCHITECT c SYSTEMS ASSAY PARAMETERS

Immunoglobulin M 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: IgM Type: Photometric Version: † Assay: IgM
Number: 1059 COMPONENT REAGENT / ASSAY WASH Volume Replicates
● Reaction definition о Reagent / Sample о Validity checks R1 AMIK9 Detergent A 345 1
Reaction mode: End up R1 VANCO Detergent A 345 1
Primary Secondary Read times R1 GENT9 Detergent A 345 1
Wavelength: 340 / 700 Main: 31 – 33 R1 DIG00 Detergent A 345 1
Last required read: 33 R1 TOBRA Detergent A 345 1
Absorbance range: ___ – ___ Color correction: ___ – ___ R1 DGT0B Detergent A 345 1
Sample blank type: Self Blank: 14 – 16 R2 AMIK9 Detergent A 345 1
R2 VANCO Detergent A 345 1
о Reaction definition ● Reagent / Sample о Validity checks R2 GENT9 Detergent A 345 1
R1 R2 R2 DIG00 Detergent A 345 1
Reagent: IGM00 Reagent volume: 167 47 R2 TOBRA Detergent A 345 1
Diluent: Saline Water volume: ___ ___ R2 DGT0B Detergent A 345 1
Diluent dispense mode: Type 0 Dispense mode: Type 0 Type 0 Cuvette Trig 10% Detergent B 345
Diluted Default
Dilution name Sample sample Diluent Water Dilution factor dilution Immunoglobulin M Serum/Plasma—Conventional Units
STD (1:5) : 20.0 3.0 80 ___ = 1:5.00 ●
UNDILUTED : 3.0 ___ ___ ___ = 1:1.00 о Configure assay parameters — Results
1:10 : 10.0 3.0 90 ___ = 1:10.00 о о General о Calibration о SmartWash ● Results о Interpretation
Assay: IgM Assay number: 1059
Dilution default range: Result units: mg/dL
о Reaction definition о Reagent / Sample ● Validity checks Low-Linearity: 5
Reaction check: Rate Subtraction
High-Linearity: 297‡‡
A B
Gender and age specific ranges:*
Read time: 20 – 23 10 – 13
GENDER AGE (UNITS) NORMAL** EXTREME
Calculation limits: -0.1000 – 0.0750
Male 0 – 130 (Y) 22 – 240
Maximum absorbance variation: ___ Female 0 – 130 (Y) 33 – 293
Either 0 – 130 (Y) 22 – 293
Configure assay parameters — Calibration
о General ● Calibration о SmartWash о Results о Interpretation
Assay: IgM Calibration method: Spline Configure result units
● Calibrators о Volumes о Intervals о Validity checks Assay: IgM
Calibrator set: Calibrator level: Concentration: Version: †
SP Blank: Water 0†† Result units: mg/dL
Cal 1: SP1 ‡ Decimal places: 0 [Range 0 – 4]
Replicates: 3 [Range 1 – 3] Cal 2: SP2 ‡ Correlation factor: 1.0000
Cal 3: SP3 ‡ Intercept: 0.0000
Cal 4: SP4 ‡
Cal 5: SP5 ‡
Immunoglobulin M Serum/Plasma—SI Units
о Calibrators ● Volumes о Intervals о Validity checks Configure assay parameters — Results
Calibrator: SP Diluted
Calibrator level Sample sample Diluent Water о General о Calibration о SmartWash ● Results о Interpretation
Blank: Water 3.0 ___ ___ ___ Assay: IgM Assay number: 1059
Cal 1: SP1 3.0 ___ ___ ___ Dilution default range: Result units: g/L
Cal 2: SP2 3.0 ___ ___ ___ Low-Linearity: 0.05
Cal 3: SP3 3.0 ___ ___ ___ High-Linearity: 2.97‡‡
Cal 4: SP4 3.0 ___ ___ ___ Gender and age specific ranges:*
Cal 5: SP5 3.0 ___ ___ ___ GENDER AGE (UNITS) NORMAL** EXTREME
Male 0 – 130 (Y) 0.22 – 2.40
Female 0 – 130 (Y) 0.33 – 2.93
о Calibrators о Volumes ● Intervals о Validity checks Either 0 – 130 (Y) 0.22 – 2.93
Calibration intervals:
Full interval: 1368 (hours)
Calibration type: Configure result units
Adjust type: None
Assay: IgM
Version: †
о Calibrators о Volumes о Intervals ● Validity checks Result units: g/L
Blank absorbance range: _____ – _____ Decimal places: 2 [Range 0 – 4]
Span: Blank – Blank Correlation factor: 1.0000
Span absorbance range: _____ – _____ Intercept: 0.0000
Expected cal factor: 0.00
Expected cal factor tolerance %: 0
* User defined.
** Reference range is for > 12 years of age.
† 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 in the calibrator value sheet. In ARCHITECT software version 5.00 and above, these values are defined on the
Configure calibrator set screen.
‡‡ Edit to highest calibrator concentration specified in the calibrator value sheet.
6
AEROSET SYSTEM ASSAY PARAMETERS

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

Assay Configuration: Outline Page Assay Configuration: Outline Page
Assay Name Assay # Line Assay Name Assay # Line
IgM 59 B-Line IgM 59 B-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 22 293 0.0 0.0* * * 0.0* 0.0 0.22 2.93 0.0 0.0* *
5 L-Linear Range-H 297‡‡ 0.05 L-Linear Range-H 2.97‡‡
Reference Ranges* Reference Ranges*
Age Male Female Age Male Female
0 Year 22 – 240 33 – 293 0 Year 0.22 – 2.40 0.33 – 2.93
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 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 340 / 700 31 – 33 / 0 – 0 0.0 END UP 340 / 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
IgM ( 59 ) 14 – 16 0–0 0.0 – 0.0 IgM ( 59 ) 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 3.0 80 0 Rgt Name/Pos Standard 20.0 3.0 80 0 Rgt Name/Pos
Dil 1 3.0 0.0 0 0 Diluent: DILUENT D–18* Dil 1 3.0 0.0 0 0 Diluent: DILUENT D–18*
Dil 2 10.0 3.0 90 0 Type# 0 Dil 2 10.0 3.0 90 0 Type# 0
Rgt Name/Pos R.Vol W.Vol Type# Rgt Name/Pos R.Vol W.Vol Type#
Reagent 1 IGM0011 – ___* 167 0 0 Reagent 1 IGM0011 – ___* 167 0 0
Reagent 2 IGM0012 – ___* 47 0 0 Reagent 2 IGM0012 – ___* 47 0 0
Reaction Check Read Time – A/B Range Minimum Reaction Check Read Time – A/B Range Minimum
RATE SUB 20 – 23 / 10 – 13 -0.1 – 0.075 0.0 RATE SUB 20 – 23 / 10 – 13 -0.1 – 0.075 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 1368 Spline 1368
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 3.0 0.0 0 0 0.0 – 0.0 BLK Water 3.0 0.0 0 0 0.0 – 0.0
C1 SP 1 3.0 0.0 0 0 Cal Deviation C1 SP 1 3.0 0.0 0 0 Cal Deviation
C2 SP 2 3.0 0.0 0 0 0.0 C2 SP 2 3.0 0.0 0 0 0.0
C3 SP 3 3.0 0.0 0 0 FAC Limit (%) C3 SP 3 3.0 0.0 0 0 FAC Limit (%)
C4 SP 4 3.0 0.0 0 0 10 C4 SP 4 3.0 0.0 0 0 10
C5 SP 5 3.0 0.0 0 0 C5 SP 5 3.0 0.0 0 0

Assay Configuration: SmartWash Page Assay Configuration: SmartWash Page

Rgt Probe Rgt Probe
Reagent Wash Vol Reagent Wash Vol
IRON042 AlkW 345 IRON042 AlkW 345
IRON052 AlkW 345 IRON052 AlkW 345
VANCO51 AlkW 345 VANCO51 AlkW 345
VANCO52 AlkW 345 VANCO52 AlkW 345
AMIK941 AlkW 345 AMIK941 AlkW 345
AMIK942 AlkW 345 AMIK942 AlkW 345
DIG0051 AlkW 345 DIG0051 AlkW 345
DIG0012 AlkW 345 DIG0012 AlkW 345
TOBRA41 AlkW 345 TOBRA41 AlkW 345
TOBRA42 AlkW 345 TOBRA42 AlkW 345
DGT0B11 AlkW 345 DGT0B11 AlkW 345
DGT0B12 AlkW 345 DGT0B12 AlkW 345
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 for > 12 years of age.
‡‡ Edit to highest calibrator concentration specified in the calibrator value sheet.
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