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Cocaine Metabolite 3B24-20 34-5076/R9 Cocaine Metabolite E Cocaine Metabolite 3B24-20 34-5076/R9 Cocaine Metabolite Customer Service United States: 1-877-4ABBOTT International: Call your Abbott Representative 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. Read Highlighted Changes Revised September, 2008 Key to symbols used List Number Expiration Date In Vitro Diagnostic Medical Device Lot Number Store at 2-8°C Calibrator (A-F) Store at 15-30°C Control Low, Medium, High (L, M, H) Consult instructions for use Sample Cups Reagent Pack Manufacturer Authorized Representative Reaction Vessels See REAGENTS section for a full explanation of symbols used in reagent component naming. Abbott Laboratories Diagnostics Division Abbott Park, IL 60064 USA Printed in USA 1 33B24-1C-20_Eng_ReIn.inddB24-1C-20_Eng_ReIn.indd 1 99/17/2008/17/2008 111:38:481:38:48 AAMM Colors: PMS 3165 PMS 222 BLACK LE: Pam DTP: Scott NAME • Cocaine Metabolite from the sample and the AxSYM Cocaine Cocaine Metabolite Metabolite Fluorescein Tracer compete for binding sites on the antibody molecule. INTENDED USE • The intensity of polarized fluorescent light is measured by the FPIA The AxSYM Cocaine Metabolite assay is a semi-quantitative reagent optical assembly. system for the detection of the primary urinary metabolite of Cocaine, benzoylecgonine in human urine. Measurements obtained are used as an For further information, refer to the AxSYM System Operations Manual, aid in the diagnosis and treatment of cocaine use or abuse. Section 3. The AxSYM Cocaine Metabolite assay provides only a preliminary REAGENTS analytical test result. A more specific alternate chemical method REAGENT PACK, 100 TESTS must be used in order to obtain a confirmed analytical result. Gas AxSYM Cocaine Metabolite Reagent Pack (3B24-20) * chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.1 Clinical considerations and professional • 1 Bottle (5.4 mL) < 5% Cocaine Metabolite Antiserum (Sheep) judgment should be applied to any drug of abuse test result, particularly in buffer with protein stabilizer. Preservative: Sodium Azide. when preliminary positive results are used. (Reagent Bottle 1). • 1 Bottle (4.0 mL) Pretreatment Solution, buffer with protein stabilizer. SUMMARY AND EXPLANATION OF TEST Preservative: Sodium Azide. (Reagent Bottle 2). The AxSYM Cocaine Metabolite assay utilizes Fluorescence Polarization • 1 Bottle (5.3 mL) < 0.01% Cocaine Metabolite Fluorescein Tracer Immunoassay (FPIA) technology. Refer to the AxSYM System Operations in buffer with surfactant and protein stabilizer. Preservative: Sodium Manual, Section 3, under Principles of Operation for a discussion of this Azide. (Reagent Bottle 3). technology. * 3B24-99 includes an AxSYM Cocaine Metabolite Reagent Pack Cocaine is a frequently abused drug. The drug is administered by nasal (100 Tests) and reaction vessels (100 each). 3B24-20 includes these insufflation, intravenous injection or in the free base form as smoke items for international shipments. inhalation. The urinary elimination of cocaine and its metabolite begins within 20 minutes of its intranasal administration.2-6 A single dose is excreted CALIBRATORS in a 24-hour urine as cocaine (1 - 9 %), benzoylecgonine (35 - 54 %), XSYSTEMS Cocaine Metabolite Calibrators (9670-06) ecgonine methyl ester (32 - 49 %) and ecgonine (not quantitated).2 6 Bottles (4 mL A, 2.5 mL each B-F) of XSYSTEMS Cocaine Metabolite The Cocaine Metabolite assay is designed to perform at a variety of Calibrators. Calibrator A contains human urine and Calibrators B through commonly used cut-off levels. The analyzer has been factory set at F contain benzoylecgonine prepared in human urine to yield the following 300.00 ng/mL. NIDA recommends a 300 ng/mL cut-off for screening assays concentrations: detecting Cocaine Metabolite (Federal Register June 9, 1994). Abbott Laboratories recommends the use of this cut-off, if appropriate for your Benzoylecgonine Concentration client population. To configure the cut-off in your laboratory refer to the INSTRUMENT PROCEDURE section in this insert. Bottle (ng/mL) (μmol/L) Selection of the cut-off value should be based on review of the laboratory’s 0 0.00 and it’s clients’ needs, sensitivity of available confirmation methods and 300 1.04 the sensitivity and cross-reactivity data of the assay itself. 1000 3.46 2000 6.91 BIOLOGICAL PRINCIPLES OF THE PROCEDURE 3000 10.37 The AxSYM Cocaine Metabolite assay is based on Fluorescence 5000 17.28 Polarization Immunoassay (FPIA) technology. The AxSYM Cocaine Preservative: Sodium Azide. Metabolite Reagents and sample are pipetted in the following sequence: CONTROLS SAMPLING CENTER XSYSTEMS Multiconstituent Controls (9687-12) • Sample and all AxSYM Cocaine Metabolite Reagents required for one test are pipetted by the sampling probe into various wells of a 2 Bottles each of Low, Medium and High (4.5 mL each) prepared in human Reaction Vessel (RV). urine diluent to read within the following ranges: • Sample and Solution 4 (Line Diluent) are pipetted into one well of Benzoylecgonine the RV. Concentration Range The RV is immediately transferred into the Processing Center. Further Bottle (ng/mL) (μmol/L) (ng/mL) (μmol/L) pipetting is done in the Processing Center with the processing probe. 500 1.73 342.66 - 657.34 1.184 - 2.272 PROCESSING CENTER 1500 5.18 1098.20 - 1901.80 3.795 - 6.573 3000 10.37 2185.92 - 3814.08 7.554 - 13.182 • An aliquot of the predilution mixture, pretreatment/antibody mixture and Solution 4 (Line Diluent) are transferred to the cuvette of the RV. Preservative: Sodium Azide. • After an incubation period, a second aliquot of the antibody/pretreatment The calibrators and controls are matched to an Abbott internal reference mixture, Cocaine Metabolite Fluorescein Tracer and a second aliquot standard. This internal reference standard is manufactured by gravimetric of the predilution mixture are transferred to the cuvette. methods using benzoylecgonine anhydrous (not less than purity 99%) at each concentration level. OTHER REAGENTS AxSYM Probe Cleaning Solution (9A35-05) 2 Bottles (220 mL each) AxSYM Probe Cleaning Solution containing 2% Tetraethylammoniumhydroxide (TEAH). 2 33B24-1C-20_Eng_ReIn.inddB24-1C-20_Eng_ReIn.indd 2 99/17/2008/17/2008 111:38:531:38:53 AAMM Solution 4 (Line Diluent) (8A46) 1 Bottle (10 L) Solution 4 (Line Diluent) The AxSYM Probe Cleaning Solution and Solution 4 containing 0.1 M Phosphate Buffer. Preservatives: Sodium Azide and (Line Diluent) must be stored at 15 - 30°C. Antimicrobial Agent. INSTRUMENT PROCEDURE WARNINGS AND PRECAUTIONS Assay File Installation For In Vitro Diagnostic Use. The AxSYM Cocaine Metabolite Assay File must be installed on the AxSYM SAFETY PRECAUTIONS System from one of the following software disks, prior to performing • CAUTION: This product contains material derived from human urine. Cocaine Metabolite assays: Human urine sourced from healthy adults has not been shown to • 9B65-02 or 3D54-01 (112 hours on-board Stability) be a source of infectious agents, however, it is recommended that • 3D54-02, or higher (336 hours on-board Stability) all human samples and reagents should be handled as potentially infectious material. Use precautions as specified in the OSHA Refer to the AxSYM System Operations Manual, Section 2, for proper Standard on Bloodborne Pathogens or other equivalent biosafety installation procedures. guidelines.7,8,9,10 AxSYM Cocaine Metabolite Assay Parameters • This product contains sodium azide; for a specific listing, refer to the The default values for the assay parameters used for the AxSYM Cocaine REAGENTS section. Contact with acids liberates very toxic gas. This Metabolite assay are listed below. Assay parameters that can be edited material and its container must be disposed of in a safe way. contain a (>) symbol. These parameters can be displayed and edited • For product not classified as dangerous per European Directive according to the procedure in the AxSYM System Operations Manual, 1999/45/EC as amended - Safety data sheet available for professional Section 2: Installation Procedures and Special Requirements. In order user on request. to obtain values for the parameters with an asterisk (*), review the specific Assay Parameter screen. Press PRINT to print the assay parameters. HANDLING PRECAUTIONS Assay Parameters • Do not use Reagent Packs beyond the expiration date or the maximum on-board stability. A maximum of 336 cumulative hours on-board 1 Long Assay Name (English): Cocaine_Met the AxSYM System are available when using assay file version 6 Abbrev Assay Name (English): Cocaine 11 Assay Number: 500 1 00 400 or higher (located on the Abused Drugs/Toxicology Assay 12 Assay Version: * Disk 3D54-02 or higher). A maximum of 112 cumulative hours on-board 13 Calibration Version: * the AxSYM System are available when using assay file version 14 Assay File Revision: * 1 00 300 (located on the Abused Drugs/Toxicology Assay Disk 15 Assay Enabled > ON 3D54-01; or assay version 1 00 200 located on the Cocaine Metabolite 17 Assay Type: FPIA Assay Disk 9B65-02). 18 Standard Cal Reps > 2 • Do not mix reagents from different reagent packs regardless of 21 Cal A Concentration: 0.00 22 Cal B Concentration: 300.00 lot number. 23 Cal C Concentration: 1000.00 Refer to the AxSYM System Operations Manual, Sections 7 and 8, for 24 Cal D Concentration: 2000.00 a more detailed discussion of safety and handling precautions during 25 Cal E Concentration: 3000.00 system operation. 26 Cal F Concentration: 5000.00 43 Default Dilution Protocol > UNDILUTED STORAGE INSTRUCTIONS 44 Default Calibration Method > Standard Cal 45 Selected Result Concentration Units > ng/mL The AxSYM Cocaine Metabolite Reagent Pack, 46 Selected Result Decimal Places > 2 XSYSTEMS Cocaine Metabolite Calibrators and XSYSTEMS Multiconstituent 62 Blank I-Max background intensity: * Controls must be stored at 2 - 8°C. They may be used immediately after 63 Min Tracer-Min net intensity: * 73 Low Limit - Normal/Therapeutic Range lower limit > 0.00 removing them from the refrigerator.
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