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I Digoxin 1P32 48-1968/R3 en system i Digoxin 1P32 48-1968/R3 Read Highlighted Changes Revised February 2009 i Digoxin Customer Service United States: 1-877-4ABBOTT International: Call your Abbott Representative This package insert must be read carefully prior to use. Package insert instructions must be followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. Key to symbols used List Number Reaction Vessels In Vitro Diagnostic Medical Device Sample Cups Lot Number Septum Expiration Date Replacement Caps Store at 2-8°C Reagent Lot Assay CD-ROM Consult instructions for use Control Number Authorized Representative Serial Number Manufacturer Caution: Irritant See REAGENTS section for a full explanation of symbols used in reagent component naming. 1 11P32-49-25_Eng_ReIn.inddP32-49-25_Eng_ReIn.indd 1 22/5/2009/5/2009 2:02:232:02:23 PPMM Size: 26.0” x 9.8” 3.3” x 2.5” Color: PMS 329 LE: Glenn DTP: Scott WARNINGS AND PRECAUTIONS WARNING: Digoxin values for specimens from patients who have For in vitro diagnostic use. received DIGIBIND or DIGIFAB therapy may be impacted. See SPECIFIC PERFORMANCE CHARACTERISTICS, Interfering Safety Precautions Substances section. • CAUTION: This product requires the handling of human specimens. It is recommended that all human sourced materials be considered potentially infectious and handled in accordance with the OSHA NAME Standard on Bloodborne Pathogens.5 Biosafety Level 26 or other ARCHITECT i Digoxin appropriate biosafety practices7,8 should be used for materials that INTENDED USE contain or are suspected of containing infectious agents. The ARCHITECT i Digoxin assay is an in vitro chemiluminescent • The Microparticles and Assay Diluent contain methylisothiazolones, microparticle immunoassay (CMIA) for the quantitative measurement of which are components of ProClin, and are classified per applicable digoxin in human serum or plasma on the ARCHITECT i System with STAT European Community (EC) Directives as: Irritant (Xi). The following protocol capability. The measurements obtained are used to aid in the are the appropriate Risk (R) and Safety (S) phrases. diagnosis and treatment of digoxin overdose and in monitoring levels of R43 May cause sensitization by skin contact. digoxin to help ensure appropriate therapy. S24 Avoid contact with skin. SUMMARY AND EXPLANATION OF TEST S35 This material and its container must be disposed of in a safe way. Digoxin is a potent cardiac glycoside prescribed for the treatment of S37 Wear suitable gloves. patients suffering from congestive heart failure1 or from some types of S46 If swallowed, seek medical advice cardiac arrhythmias.2 Monitoring of serum or plasma digoxin levels is immediately and show this container or label. performed because the drug has a low therapeutic ratio (a small difference between therapeutic and tissue toxic levels) and because the symptoms • The Conjugate contains methylisothiazolones, which are components of drug overdose may resemble the original condition for which the drug of ProClin, and are classified per applicable European Community (EC) was prescribed.3 Also, digoxin dosage may require adjustment when renal Directives as: Irritant (Xi). The following are the appropriate Risk (R) function is impaired3 or when drugs known to alter the pharmacokinetics and Safety (S) phrases. of digoxin (e.g., quinidine, verapamil, or amiodarone) are coadministered.4 R36/38 Irritating to eyes and skin. Monitoring serum or plasma digoxin levels along with other clinical data can R43 May cause sensitization by skin contact. aid the physician in adjusting patient dosage to achieve optimal therapeutic S24/25 Avoid contact with skin and eyes. effect while avoiding subtherapeutic or toxic dosage levels.3 S26 In case of contact with eyes, rinse BIOLOGICAL PRINCIPLES OF THE PROCEDURE immediately with plenty of water and seek medical advice. The ARCHITECT i Digoxin assay is a one-step STAT immunoassay for the S35 This material and its container must be quantitative measurement of digoxin in human serum or plasma using disposed of in a safe way. CMIA technology with flexible assay protocols, referred to as Chemiflex. S37 Wear suitable gloves. Sample, anti-digoxin coated paramagnetic microparticles, assay diluent, S46 If swallowed, seek medical advice and digoxigenin acridinium-labeled conjugate are combined to create a immediately and show this container or label. reaction mixture. The anti-digoxin coated microparticles bind to digoxin present in the sample and to the digoxigenin acridinium-labeled conjugate. • For product not classified as dangerous per European Directive After washing, pre-trigger and trigger solutions are added to the reaction 1999/45/EC as amended - Safety data sheet available for professional mixture. The resulting chemiluminescent reaction is measured as relative user on request. light units (RLUs). An indirect relationship exists between the amount of • For information on the safe disposal of sodium azide and a detailed digoxin in the sample and the RLUs detected by the ARCHITECT i System discussion of safety precautions during system operation, refer to the optics. ARCHITECT System Operations Manual, Section 8. For additional information on system and assay technology, refer to the Handling Precautions ARCHITECT System Operations Manual, Section 3. • Do not use reagents beyond the expiration date. REAGENTS • Do not pool reagents within a kit or between reagent kits. Reagent Kit, 100 Tests • Before loading the ARCHITECT i Digoxin Reagent Kit on the system Note: Some kit sizes are not available in all countries or for use on all for the first time, the microparticle bottle requires mixing to resuspend ARCHITECT i Systems. Please contact your local distributor. microparticles that may have settled during shipment. For microparticle ARCHITECT i Digoxin Reagent Kit (1P32) mixing instructions, refer to the PROCEDURE, Assay Procedure • 1 Bottle (6.6 mL) Anti-digoxin (mouse, monoclonal) section of this package insert. coated microparticles in TRIS buffer with protein (bovine) stabilizer. • Septums MUST be used to prevent reagent evaporation and Preservative: ProClin 300. contamination and to ensure reagent integrity. Reliability of assay • 1 Bottle (5.9 mL) Digoxigenin acridinium-labeled results cannot be guaranteed if septums are not used according to conjugate in citrate buffer. Preservative: ProClin 300. the instructions in this package insert. • 1 Bottle (10.0 mL) Assay Diluent containing • To avoid contamination, wear clean gloves when placing a septum goat serum with EDTA disodium. Preservatives: ProClin 300 and on an uncapped reagent bottle. ProClin 950. • Once a septum has been placed on the reagent bottle, do not invert the bottle as this will result in reagent leakage and may Other Reagents compromise assay results. ARCHITECT i Pre-Trigger Solution • Over time, residual liquids may dry on the septum surface. These • Pre-Trigger Solution containing 1.32% (w/v) are typically dried salts and have no effect on assay efficacy. hydrogen peroxide. • For a detailed discussion of handling precautions during system ARCHITECT i Trigger Solution operation, refer to the ARCHITECT System Operations Manual, • Trigger Solution containing 0.35 N sodium Section 7. hydroxide. ARCHITECT i Wash Buffer • Wash Buffer containing phosphate buffered saline solution. Preservative: antimicrobial agents. 2 11P32-49-25_Eng_ReIn.inddP32-49-25_Eng_ReIn.indd 2 22/5/2009/5/2009 2:02:332:02:33 PPMM Storage Instructions • For accurate results, serum and plasma specimens should be free of fibrin, red blood cells, and other particulate matter. Serum specimens from patients receiving anticoagulant or thrombolytic therapy may • The ARCHITECT i Digoxin Reagent Kit must be stored contain fibrin due to incomplete clot formation. at 2-8°C in an upright position and may be used immediately after • Use caution when handling patient specimens to prevent cross removal from 2-8°C storage. contamination. Use of disposable pipettes or pipette tips is • When stored and handled as directed, reagents are stable until the recommended. expiration date. • For optimal results, inspect all specimens for bubbles. Remove bubbles • The ARCHITECT i Digoxin Reagent Kit may be stored on board the with an applicator stick before analysis. Use a new applicator stick ARCHITECT i System with STAT protocol capability for a maximum for each specimen to prevent cross contamination. of 30 days. After 30 days, the reagent kit must be discarded. For Preparation for Analysis information on tracking onboard time, refer to the ARCHITECT System • Follow the tube manufacturer’s processing instructions for serum Operations Manual, Section 5. and plasma collection tubes. Gravity separation is not sufficient for • Reagents may be stored on or off the ARCHITECT i System. If reagents specimen preparation. are removed from the system, store them at 2-8°C (with septums and • Mix thawed specimens thoroughly by low speed vortexing or by replacement caps) in an upright position. For reagents stored off the inverting 10 times. Visually inspect the specimens. If layering or system, it is recommended that they be stored in their original trays and stratification is observed, continue mixing until specimens are visibly boxes to ensure they remain upright. If the microparticle bottle does homogeneous. not remain upright (with a septum installed) while in refrigerated • To ensure consistency in results, specimens must be transferred to storage off the system, the reagent
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