Immunoglobulin M 1E01-20 30-3962/R3
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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 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 reportable range) Materials Provided 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