Haptoglobin 9D91-20 30-3966/R4
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HAPTOGLOBIN 9D91-20 30-3966/R4 HAPTOGLOBIN This package insert contains information to run the Haptoglobin 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 ABBOTT LABORATORIES ABBOTT Abbott Park, IL 60064, USA Max-Planck-Ring 2 65205 Wiesbaden Germany +49-6122-580 May 2007 ©2004, 2007 Abbott Laboratories 1 NAME REAGENT HANDLING AND STORAGE HAPTOGLOBIN Reagent Handling Remove air bubbles, if present in the reagent cartridge, with a new INTENDED USE applicator stick. Alternatively, allow the reagent to sit at the appropriate The Haptoglobin assay is used for the quantitation of haptoglobin in storage temperature to allow the bubbles to dissipate. To minimize human serum or plasma. volume depletion, do not use a transfer pipette to remove the bubbles. CAUTION: Reagent bubbles may interfere with proper detection of SUMMARY AND EXPLANATION OF TEST reagent level in the cartridge, causing insufficient reagent aspiration Haptoglobin is a protein synthesized in the liver that binds with the which could impact results. globin α-chains of hemoglobin A, F, S, or C. Haptoglobin does not bind methemoglobin, heme, or unusual forms of hemoglobin in which Reagent Storage the α-chain is missing. The haptoglobin-hemoglobin complex is rapidly Unopened reagents are stable until the expiration date when stored removed from circulation by the reticuloendothelial system to prevent/ at 2 to 8°C. minimize hemoglobin loss and to conserve iron.1 Reagent onboard stability is approximately 57 days if quality control Indications for haptoglobin quantitation include: anemia or other results meet acceptance criteria. If quality control results do not meet indicators of possible hemolysis; pregnancy-induced hypertension; acceptance criteria, refer to the QUALITY CONTROL section of this transfusion reactions (assay of pre- and post-transfusion samples); package insert. assessment of acute phase response; and evaluation of changes in the 2 α2-region of serum protein electrophoresis. WARNINGS AND PRECAUTIONS Decreased levels of haptoglobin are most frequently associated with Precautions for Users conditions of increased intravascular hemolysis or hemoglobin turnover, such as hemolytic anemias, intravascular hemolytic transfusion 1. For in vitro diagnostic use. reactions, and malaria. Extravascular hemolysis does not usually affect 2. Do not use components beyond the expiration date. haptoglobin concentrations. Other conditions associated with decreased 3. Do not mix materials from different kit lot numbers. haptoglobin levels are congenital anhaptoglobinemia (ahaptoglobinemia) 4. Do not mix fresh reagent with in-use reagents. and severe liver diseases where protein synthesis is affected.1 5. This product contains sodium azide; for a specific listing, refer to the Mechanical heart valves or vigorous athletic activity where repetitive REAGENTS section. Contact with acids liberates very toxic gas. This erythrocytic mechanical trauma may occur can cause sustained lower material and its container must be disposed of in a safe way. 1,2 haptoglobin levels. NOTE: Refer to Section 8 of the instrument-specific operations Elevated levels of haptoglobin are most frequently associated with manual for proper handling and disposal of reagents containing acute phase reactions (i.e., involving tissue infection, surgery, trauma, sodium azide. or necrosis).3 Other conditions associated with elevated haptoglobin 2 6. CAUTION: This product requires the handling of human specimens. levels are corticosteroid therapy and biliary obstruction. It is recommended that all human sourced materials be considered potentially infectious and be handled in accordance with the OSHA PRINCIPLES OF PROCEDURE Standard on Bloodborne Pathogens.4 Biosafety Level 25 or other The Haptoglobin assay is an immunoturbidimetric procedure that appropriate biosafety practices6,7 should be used for materials that measures increasing sample turbidity caused by the formation of contain or are suspected of containing infectious agents. insoluble immune complexes when antibody to haptoglobin is added to the sample. Sample containing haptoglobin is incubated with a buffer For product not classified as dangerous per European Directive (Reagent 1) and a sample blank determination is performed prior to 1999/45/EC as amended, safety data sheet available for professional the addition of haptoglobin antibody (Reagent 2). In the presence of user on request. an appropriate antibody in excess, the haptoglobin concentration is measured as a function of turbidity. SPECIMEN COLLECTION AND HANDLING Methodology: Immunoturbidimetric Suitable Specimens Serum and plasma are acceptable specimens. REAGENTS • Serum: Use serum collected by standard venipuncture techniques Reagent Kit into glass or plastic tubes with or without gel barriers. Ensure 9D91 Haptoglobin is supplied as a liquid, ready-to-use, two-reagent complete clot formation has taken place prior to centrifugation. kit which contains: Separate serum from red blood cells or gel as soon after collection as possible. 3 x 17 mL Some specimens, especially those from patients receiving 3 x 7 mL anticoagulant or thrombolytic therapy, may take longer to complete Estimated tests per kit: 230 their clotting processes. Fibrin clots may subsequently form in these sera and the clots could cause erroneous test results. Calculation is based on the minimum reagent fill volume per kit. • Plasma: Use plasma collected by standard venipuncture techniques Reactive Ingredients Concentration into glass or plastic tubes. Acceptable anticoagulants are lithium heparin (with or without gel barrier), sodium heparin, and EDTA. TRIS 100 mmol/L Ensure centrifugation is adequate to remove platelets. Separate plasma from red blood cells or gel as soon after collection as Polyethylene Glycol 30 g/L possible. Sodium Azide 0.1% Refer to the specimen collection tube manufacturer’s instructions for Anti-human haptoglobin goat serum 50% processing and handling requirements. TRIS 100 mmol/L For total sample volume requirements, refer to the instrument-specific Sodium Azide 0.1% ASSAY PARAMETERS section of this package insert and Section 5 of the instrument-specific operations manual. 2 SPECIMEN COLLECTION AND HANDLING (Continued) CALIBRATION Specimen Storage The linear high field of the assay parameters must be edited to the concentration of the highest calibrator specified in the value sheet. Serum and plasma: Analyze fresh specimens if possible. Repeated freeze/thaw cycles should be avoided to minimize potential protein Calibration is stable for approximately 57 days (1,368 hours) and is degradation. required with each change in reagent lot number. Verify calibration with at least three levels of controls according to the established quality Temperature Maximum Bibliographic control requirements for your laboratory. If control results fall outside Storage Reference acceptable ranges, recalibration may be necessary. A multi-point calibration (Spline) curve is generated using Specific 2 to 8°C 1 week 8, 9 Proteins Multiconstituent Calibrator. -20°C 2 weeks 2 For a detailed description of how to calibrate an assay, refer to Section 6 of the instrument-specific operations manual. Teitz2 suggests storage of frozen specimens at -20°C for no longer than the time interval cited above. However, limitations of laboratory For information on calibrator standardization, refer to the Specific equipment make it necessary in practice for clinical laboratories to Proteins Multiconstituent Calibrator package insert. establish a range around -20°C for specimen storage. This temperature range may be established from either the freezer manufacturer’s QUALITY CONTROL specifications or your laboratory standard operating procedure(s) for The following is the recommendation of Abbott Laboratories for quality specimen storage. control. As appropriate, refer to your laboratory standard operating NOTE: Stored specimens must be inspected for particulates. If present, procedure(s) and/or quality assurance plan for additional quality control mix and centrifuge the specimen to remove particulates prior to testing. requirements and potential corrective actions. • Three levels of quality control are to be run every 24 hours. PROCEDURE • If more frequent control monitoring is required, follow the established Materials Provided quality control procedures for your laboratory. 9D91 Haptoglobin Reagent Kit • If quality control results do not meet the acceptance criteria defined by your laboratory, patient values may be suspect. Follow Materials Required but not Provided the established quality control procedures for your laboratory. • 1E78 Specific Proteins Multiconstituent Calibrator Recalibration may be necessary. 1 x 1 mL • Review quality