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.
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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 Precautions for Users enables direct cross-linking and agglutination of particulate and cellular 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 3 4 bacterial or parasitic infection. Levels are often increased in rheumatoid Standard on Bloodborne Pathogens. Biosafety Level 2 or other 5,6 arthritis, chronic hepatocellular disease, and other chronic disorders. appropriate biosafety practices 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 fi rst 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
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 RESULTS 3** 9.6 9.4 -0.2 98.0 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 12 9 EP7-P. Interference effects were assessed by Dose Response and results are obtained. 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 50.8 108.00 250 mg/dL (2.5 g/L) 4 53.9 92.28 Range* (mg/dL) Range* (g/L) 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 Bilirubin Male 22 to 240 0.22 to 2.40 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, Precision 4th ed. Hudson, OH: Lexi-Comp; 1996:410. 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 N808080Microbiological 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 Within Run Geneva: World Health Organization, 2004. %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 %CV 1.0 0.6 0.4 Guideline—Third Edition (M29-A3). Wayne, PA: Clinical and 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 Total 8. US Pharmacopeial Convention, Inc. General notices. In: US %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 N7893National 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: ‡‡ AB 297 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. 7 8