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E / II 3B27-20 34-5052/R15 Amphetamine/ Methamphetamine II

Customer Service Read Highlighted Changes United States: 1-877-4ABBOTT International: Call your Abbott Representative Revised April, 2008

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.

Key to symbols used

List Number Expiration Date

In Vitro Diagnostic Medical Device Lot Number

Store at 2-8°C Calibrator (A-F)

Control Low, Medium, High Store at 15-30˚C (L, M, H)

Consult instructions for use Reagent Pack

Manufacturer Reaction Vessels

Sample Cups

Authorized Representative

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

Colors: PMS 3165 33B27-1C-20_Eng_ReIn.inddB27-1C-20_Eng_ReIn.indd 1 PMS 222 44/24/2008/24/2008 2:26:472:26:47 PPMM Black LE: Pam DTP: Scott NAME REAGENTS Amphetamine/Methamphetamine II REAGENT PACK, 100 TESTS INTENDED USE AxSYM Amphetamine/Methamphetamine II Reagent Pack The AxSYM Amphetamine/Methamphetamine II assay is a semi- (3B27-20)* quantitative reagent system for the detection of amphetamine and • 1 Bottle (5.2 mL) < 0.01% Amphetamine/Methamphetamine II methamphetamine in human urine. Measurements obtained aid in the Fluorescein Tracer in buffer with protein stabilizer. Preservative: diagnosis and treatment of amphetamine and/or methamphetamine use Sodium Azide. (Reagent Bottle 1) or abuse. • 1 Bottle (5.0 mL) < 25% Amphetamine/Methamphetamine II Antiserum The AxSYM Amphetamine/Methamphetamine II assay provides only a (Sheep) in buffer with protein stabilizer. Preservative: Sodium Azide. preliminary analytical test result. A more specific alternate chemical (Reagent Bottle 2) method must be used in order to obtain a confirmed analytical result. • 1 Bottle (5.4 mL) Pretreatment Solution, aqueous salt solution. Gas chromatography/mass spectrometry (GC/MS) is the preferred (Reagent Bottle 3) 1 confirmatory method. Clinical considerations and professional * 3B27-99 includes an AxSYM Amphetamine/Methamphetamine II judgement should be applied to any drug of abuse test result, Reagent Pack (100 tests) and reaction vessels (100 each). 3B27-20 particularly when preliminary positive results are used. includes these items for international shipments. SUMMARY AND EXPLANATION OF THE TEST CALIBRATORS The AxSYM Amphetamine/Methamphetamine II assay utilizes XSYSTEMS Amphetamine/Methamphetamine II Calibrators (1A99-06) Fluorescence Polarization Immunoassay (FPIA) technology. Refer to 6 Bottles (4 mL A, 2.5 mL each B-F) of XSYSTEMS Amphetamine/ the AxSYM System Operations Manual, Section 3, under Principles of Methamphetamine II Calibrators. Calibrator A contains human urine Operation for a discussion of this technology. diluent and Calibrators B through F contain d-Amphetamine prepared in Amphetamine and methamphetamine are central nervous system human urine diluent to yield the following concentrations: drugs. They are usually administered orally or by intravenous injection. These drugs are prescribed for treatment of obesity, narcolepsy d-Amphetamine and hypotension.2,3 Because of their stimulant effects, the drugs are Concentration commonly sold illicitly and abused. Bottle (ng/mL) (μmol/L) The AxSYM Amphetamine/Methamphetamine II assay is designed to perform at a variety of commonly used cut-off levels. The analyzer 0 0.00 has been factory set at 1000.00 ng/mL. SAMHSA (NIDA) recommends a 1000 ng/mL cut-off for screening assays detecting amphetamine 150 1.11 (Federal Register June 9, 1994). Abbott Laboratories recommends the use of this cut-off if appropriate for your client population. To configure 300 2.22 the cut-off in your laboratory, refer to the INSTRUMENT PROCEDURE section in this insert. 1000 7.40 Selection of the cut-off value should be based upon review of your laboratory’s and clients’ needs, sensitivity of available confirmation 3000 22.20 methods and the sensitivity and cross-reactivity data of the assay itself. 8000 59.20 BIOLOGICAL PRINCIPLES OF THE PROCEDURE Preservative: Sodium Azide. The AxSYM Amphetamine/Methamphetamine II assay is based on Fluorescence Polarization Immunoassay (FPIA) technology. The AxSYM Abbott manufactures internal reference standards for Amphetamine/ Amphetamine/Methamphetamine II Reagents and sample are pipetted in Methamphetamine II using d-Amphetamine Sulfate [purity ≥98.0%, the following sequence: Assay (Dried Basis)]. Amphetamine/Methamphetamine II Calibrators are manufactured gravimetrically and tested against these internal reference SAMPLING CENTER standards. • Sample, pretreatment, and aliquot of antibody and Solution 4 (Line CONTROLS Diluent) required for one test are pipetted by the sampling probe into a well of the Reaction Vessel (RV). XSYSTEMS Multiconstituent Controls (9687-12) • An aliquot of the antibody is diluted in the cuvette. 2 Bottles each of Low, Medium and High (4.5 mL each) in human urine diluent to read within the following ranges: • Fluorescein tracer is diluted in a well of the RV. The RV is immediately transferred into the Processing Center. Further d-Amphetamine pipetting is done in the Processing Center with the processing probe. Concentration Range PROCESSING CENTER • An aliquot of the sample/pretreatment/antibody mixture and Solution Bottle (ng/mL) (μmol/L) (ng/mL) (μmol/L) 4 (Line Diluent) are transferred to the cuvette of the RV. 500 3.70 304.67 - 695.33 2.25 - 5.15 • After an incubation period, a second aliquot of the sample/antibody/ pretreatment mixture, and AxSYM Amphetamine/Methamphetamine II 1500 11.10 983.52 - 2016.48 7.28 - 14.92 Fluorescein Tracer is transferred to the cuvette. 4000 29.60 2859.85 - 5140.15 21.16 - 38.04 • Amphetamine and/or methamphetamine from the sample and the Preservative: Sodium Azide. AxSYM Amphetamine/Methamphetamine II Fluorescein Tracer compete for binding sites on the antibody molecule. OTHER REAGENTS • The intensity of polarized fluorescent light is measured by the FPIA AxSYM Probe Cleaning Solution (9A35-05) optical assembly. 2 Bottles (220 mL each) AxSYM Probe For further information, refer to the AxSYM System Operations Manual, Cleaning Solution containing 2% Tetraethylammoniumhydroxide (TEAH). Section 3. Solution 4 (Line Diluent) (8A46) 1 Bottle (10 L) Solution 4 (Line Diluent) containing 0.1 M Phosphate Buffer. Preservatives: Sodium Azide and Antimicrobial Agent. WARNINGS AND PRECAUTIONS For In Vitro Diagnostic Use. SAFETY PRECAUTIONS • CAUTION: This product contains material derived from human urine. Human urine sourced from healthy adults has not been shown to be a source of infectious agents, however, it is recommended that these reagents and human specimens be handled as potentially infectious material. Use precautions as specified in the OSHA Standard on Bloodborne Pathogens or other appropriate biosafety guidelines.4,5,6,7 2

33B27-1C-20_Eng_ReIn.inddB27-1C-20_Eng_ReIn.indd 2 44/24/2008/24/2008 2:26:512:26:51 PPMM • This product contains sodium azide; for a specific listing, refer to the REAGENTS section. Contact with acids liberates very toxic gas. This Assay Parameters material and its container must be disposed of in a safe way. 1 Long Assay Name (English): Amphet/Meth_ II For product not classified as dangerous per European Directive 6 Abbrev Assay Name (English): Amph_Met 1999/45/EC as amended - Safety data sheet available for professional user on request. 11 Assay Number: 516 HANDLING PRECAUTIONS 12 Assay Version: * • Do not use kits beyond the expiration date or a maximum of 13 Calibration Version: * 224 cumulative hours on-board the AxSYM System. • Do not mix reagents from different reagent packs regardless of lot 14 Assay File Revision: * number. 15 Assay Enabled > ON Refer to the AxSYM System Operations Manual, Sections 7 and 8, for 17 Assay Type: FPIA a more detailed discussion of safety and handling precautions during system operation. 18 Standard Cal Reps > 2 STORAGE INSTRUCTIONS 21 Cal A Concentration: 0.00 22 Cal B Concentration: 150.00 The AxSYM Amphetamine/Methamphetamine II Reagent 23 Cal C Concentration: 300.00 Pack, XSYSTEMS Amphetamine/Methamphetamine II Calibrators, and XSYSTEMS Multiconstituent Controls must be stored at 2-8°C. They may 24 Cal D Concentration: 1000.00 be used immediately after removing them from the refrigerator. 25 Cal E Concentration: 3000.00 Calibrators and Controls should be returned to 2-8°C storage immediately after use. 26 Cal F Concentration: 8000.00 Reagents are stable until the expiration date when stored and handled 43 Default Dilution Protocol > UNDILUTED as directed. 44 Default Calibration Method > Standard Cal The AxSYM Amphetamine/Methamphetamine II Reagent Pack may be on-board the AxSYM System for a maximum of 224 cumulative hours; 45 Selected Result Concentration Units > ng/mL for example 28 eight hour shifts. Recalibration may be required to obtain 46 Selected Result Decimal Places > 2 maximum on-board reagent stability. More frequent use of controls may be required to monitor reagent performance within the same lot. Refer to 62 Blank I-Max background intensity: * the AxSYM System Operations Manual, Sections 2 and 5 and Appendices, 63 Min Tracer-Min net intensity: * for further information on tracking on-board time. 73 Low Limit - Normal/Therapeutic Range lower limit > 0.00 The AxSYM Probe Cleaning Solution and Solution 4 74 High Limit - Normal/Therapeutic Range upper limit > 0.00 (Line Diluent) must be stored at 15-30°C. 75 Low Extreme Value > 0.00 INSTRUMENT PROCEDURE 76 High Extreme Value > 0.00 Assay File Installation 80 Interpretation Option to use > 1 The AxSYM Amphetamine/Methamphetamine II Assay File must be installed on the AxSYM System from the following software disk, prior to 84 Hold results with POS interpretation > OFF performing the Amphetamine/Methamphetamine II assay: 85 Hold results with NEG interpretation > OFF • 3D54-09, or higher (224 hours on-board Stability) 91 Low Range Undiluted: * Refer to the AxSYM System Operations Manual, Section 2, for proper installation procedures. 92 High Range Undiluted: * AxSYM Amphetamine/Methamphetamine II Assay Parameters 116 Positive Interpretation Cutoff > 1000.00 The default values for the assay parameters used for the AxSYM 117 Negative Interpretation Cutoff > 1000.00 Amphetamine/Methamphetamine II assay are listed below. Assay NOTE: Parameter 45 can be edited to the alternate result unit parameters that can be edited contain a (>) symbol. These parameters can be displayed and edited according to the procedure in the AxSYM μg/mL or μmol/L. System Operations Manual, Section 2: Installation Procedures and Special Requirements. In order to obtain values for the parameters with The AxSYM Amphetamine/Methamphetamine II values available for an asterisk (*), review the specific Assay Parameter Screen. Press PRINT parameter #80 (Interpretation Option to use) are: to print the assay parameters. POS Interp NEG Interp GRY Interp 1. POSITIVE NEGATIVE NONE 2. NONE NONE NONE Refer to the AxSYM System Operations Manual for a detailed description of Instrument Procedures. Editable Interpretation Cut-Off AxSYM Drugs of Abuse/Toxicology Assay Disk 3D54-09, or higher, installed on AxSYM System Software Version 3.6, or higher, provides the ability to edit the Interpretation range. Assay Parameters “116 Positive Interpretation Cutoff” and “117 Negative Interpretation Cutoff” have a default setting of 1000.00 ng/mL. Any result at or above the cut-off will provide a POSITIVE interpretation along with a numerical value. Any result below the cut-off will provide a NEGATIVE interpretation along with the numerical value. This assay parameter may be edited to a cut-off appropriate for your client population. When using interpretations, Assay Parameters 116 and 117 MUST be edited to the same value to avoid an incorrect interpretation being provided for a result. Refer to the AxSYM System Operations Manual, Section 2, for further information on editing assay parameters.

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33B27-1C-20_Eng_ReIn.inddB27-1C-20_Eng_ReIn.indd 3 44/24/2008/24/2008 2:26:512:26:51 PPMM SAMPLE COLLECTION AND PREPARATION FOR ANALYSIS Assay Procedure • The urine sample must be collected in a clean, previously unused Sections 5 and 6 of the AxSYM System Operations Manual contain container. Samples should be refrigerated (2-8°C) upon collection detailed steps for performing assay calibration and sample testing and stored frozen (-10°C or colder) if not analyzed within 48 hours.8,9 procedures. Frozen samples must be thawed and mixed thoroughly prior to Prior to ordering tests, confirm that the System inventory of Reaction analysis. Sodium azide (0.1%), boric acid (0.1%) and sodium fluoride Vessels and Solution 4 (Line Diluent) is sufficient. (0.013%) may be used as urine preservatives. The operator may obtain an Orderlist Report by pressing PRINT. The • The AxSYM System does not provide the capability of verifying printout contains sample placement information and minimum STAT sample type. It is the responsibility of the operator to verify the sample cup volume requirements for all tests ordered. It is recommended correct sample type(s) is (are) used in the AxSYM Amphetamine/ that this report be referenced when loading samples into sample segments. Methamphetamine II assay. When using Host Order Query, the Orderlist Report is not available. Refer • As thimerosal poses a potential health hazard at levels required to the AxSYM System Operations Manual, Section 5: Ordering Patient for preserving samples, it is not commonly used as a preservative. Samples, for a description of the Host Order Query option. Samples containing thimerosal may give falsely elevated results. CAUTION: When operating the AxSYM System, always observe the • Inspect all samples for bubbles. Remove bubbles prior to analysis. following: • When shipped, samples must be packaged and labeled in compliance • The System status must be WARMING, PAUSED, READY, or with applicable federal and international regulations covering the STOPPED before adding or removing sample segments, reagent transport of clinical samples and etiologic agents. packs or Reaction Vessels (RVs). Refer to the AxSYM System Operations Manual, Section 5, for a detailed • An “Error Code 5066 Matrix cell not detected, trap door, processing discussion of on-board sample storage constraints. center” may be displayed when the instrument homes the motors. Sample Volume If performing only FPIA (and/or REA) assays, select OK to proceed The sample volume required to perform a single Amphetamine/ with testing. Methamphetamine II test on the AxSYM System varies depending on • Do not open the Interior Waste Door or the AxSYM Processing Center the type of sample container used. For sample cups, a ROUTINE test Cover while any test is in process. If opened, all processing will stop. requires 150 μL and a STAT test requires 100 μL. For every additional Tests in process will be terminated and must be repeated. Amphetamine/Methamphetamine II test (ROUTINE or STAT) from the • When testing is completed, it is recommended that samples and same container, an additional 50 μL of sample is required. the AxSYM Amphetamine/Methamphetamine II Reagent Pack are The sample cup minimum volumes for both STAT and ROUTINE tests removed from the Sampling Center to maximize the on-board reagent are calculated by the AxSYM System. They are displayed on the Order pack use. Store Reagent Pack at 2-8°C. screen at the time the test(s) is (are) ordered and printed in the Orderlist SAMPLE DILUTION PROCEDURES Report. When using Host Order Query, the Order screen information and CAUTION: The automated dilution protocol, as described in the AxSYM the Orderlist Report are not available. Refer to AxSYM System Operations System Operations Manual, Section 5, CANNOT BE USED with the Manual, Section 5, for a description of the Host Order Query option. AxSYM Amphetamine/Methamphetamine II assay. If the assay is configured for auto retest, the additional sample volume Manual Dilution Protocol needed for the retest will not be displayed on the Order screen at the time If a numerical value is desired for patient samples reported as the test(s) is(are) ordered. Therefore, the total sample volume should > 8000 ng/mL, the urine sample may be manually diluted with XSYSTEMS include an additional 50 μL of sample. Amphetamine/Methamphetamine II Calibrator A, and repeated on the Refer to the AxSYM System Operations Manual, Section 5, for sample AxSYM System. The concentration reported by the AxSYM System must volume requirements in primary or aliquot tubes and calibrators/control be multiplied by the manual dilution factor to obtain the final sample requirements for multiple reagent lots. concentration. AxSYM AMPHETAMINE/METHAMPHETAMINE II Final Sample PROCEDURE Concentration = Reported Concentration x Manual Dilution Factor Materials Provided Manual • 3B27-99 AxSYM Amphetamine/Methamphetamine II (Volume of Sample + Volume of Dilution Reagent) Reagent Kit, containing: Dilution Factor = Volume of Sample AxSYM Amphetamine/Methamphetamine II QUALITY CONTROL PROCEDURES CALIBRATION 100 The AxSYM Amphetamine/Methamphetamine II assay must be calibrated Materials Required But Not Provided using a Standard Calibration (6 - point) procedure. • 1A99-06 XSYSTEMS Amphetamine/Methamphetamine II To review the detailed results of a calibration curve, refer to the AxSYM Calibrators System Operations Manual, Section 6. • 9687-12 XSYSTEMS Multiconstituent Controls Standard Calibration • 8A46 The Standard Calibration procedure is performed using XSYSTEMS Amphetamine/Methamphetamine II Calibrators A, B, C, D, E, and F in • 9A35-05 AxSYM duplicate. A single sample of all levels of controls must be tested to evaluate the assay calibration. • 8A76-01 Once the AxSYM Amphetamine/Methamphetamine II calibration is • Pipettes/Pipette tips (Optional) to deliver the volume specified on accepted and stored, all subsequent samples may be tested without the order screen further calibration unless: CAUTION: • A reagent pack with a new lot number is used • When manually dispensing sample into sample cups, verify that • Control values are out of their specific range dispensing equipment does not introduce cross contamination and Refer to the AxSYM System Operations Manual, Section 6, for: delivers the specified sample volume. Use a separate pipette tip for • Setting up an assay calibration each sample. • When recalibration may be necessary • For optimal performance, it is important to follow the routine • Calibration verification maintenance procedures defined in the AxSYM System Operations Manual, Section 9. If your laboratory requires more frequent maintenance, follow those procedures.

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33B27-1C-20_Eng_ReIn.inddB27-1C-20_Eng_ReIn.indd 4 44/24/2008/24/2008 2:26:512:26:51 PPMM The AxSYM System verifies that the results of an assay calibration meet EXPECTED VALUES the specifications assigned to selected validity parameters. An error Concentrations of drugs and/or metabolite(s) detected in urine have not message occurs when the calibration fails to meet a specification. Refer been correlated to drug levels in the bloodstream nor with degree of to the AxSYM System Operations Manual, Section 10, for an explanation impairment. The presence of a drug and/or metabolite(s) in urine is only of the corrective actions for the error code. Refer to the AxSYM System an indication of previous drug exposure.10 Operations Manual, Appendices, for an explanation of the calibration validity parameters that may be used by the AxSYM System. SPECIFIC PERFORMANCE CHARACTERISTICS Operator Verification Precision Precision was determined as described in the National Committee for An acceptable AxSYM Amphetamine/Methamphetamine II calibration 11 curve should have all controls within the acceptable ranges. Clinical Laboratory Standards (NCCLS) Protocol EP5-A. A three-member urine panel was assayed, using a single lot of reagents and a single QUALITY CONTROL calibration, in replicates of 2 at two separate times per day for 20 days The recommended control requirement for an AxSYM Amphetamine/ on 2 instruments. Data from this study yielded CVs of less than or equal Methamphetamine II assay is a single sample of at least two control to 12%. levels tested once every 24 hours, each day of use. Controls may be Representative data follow. placed in any position in the Sample Carousel. Instrument 1. If the quality control procedures in your laboratory require more frequent use of controls to verify test results, follow those procedures. Target Mean To achieve maximum on-board reagent stability, more frequent use of Control Concentration Concentration Value Within Run Total Run controls may be required to monitor reagent performance within the same Levels (ng/mL) (ng/mL) SD %CV SD %CV lot. Low 500 550.86 58.54 10.63 61.62 11.19 Ensure that assay control values are within the concentration ranges Medium 1500 1557.88 119.97 7.70 167.91 10.78 specified in the package insert. Refer to the REAGENTS, CONTROLS High 4000 3734.92 212.43 5.69 245.85 6.58 section of this package insert for XSYSTEMS Multiconstituent Control ranges. n=80 INDICATIONS OF INSTABILITY OR DETERIORATION OF REAGENTS Instrument 2. When an Amphetamine/Methamphetamine control value is out of the Target Mean specified range, it may indicate deterioration of the reagents or errors in Control Concentration Concentration Value Within Run Total Run technique. Associated test results may be invalid and require retesting. Levels (ng/mL) (ng/mL) SD %CV SD %CV Assay recalibration may be indicated. Refer to the AxSYM System Low 500 564.79 62.27 11.03 66.98 11.86 Operations Manual, Section 10, for further troubleshooting information. Medium 1500 1522.78 134.70 8.85 145.11 9.53 The AxSYM System has a capability to generate a Levey-Jennings plot of each assay’s quality control performance. Refer to the AxSYM System High 4000 3615.64 183.34 5.07 218.62 6.05 Operations Manual, Section 5, for further information. At the discretion n=80 of the laboratory, selected quality control rules may be applied to the Accuracy By Recovery quality control data. Two sets of calibrators and controls were prepared by adding known RESULTS quantities of d-amphetamine to human urine and AxSYM Solution 4 The AxSYM Amphetamine/Methamphetamine II assay is a semi-quantitative (Line Diluent) to levels of 150, 300, 500, 1000, 1500, 3000, 4000 and reagent system. The AxSYM Amphetamine/Methamphetamine II assay 8000 ng/mL. The analyzer was calibrated with urine calibrators and both provides only a preliminary analytical result. A more specific alternate sets of calibrators and controls were assayed relative to this calibration. chemical method must be used in order to obtain a confirmed analytical Percent recovery = 100 x (“concentration in Solution 4 (Line Diluent)” result. Gas chromatography/mass spectrometry (GC/MS) is the preferred divided by “concentration in urine”). 1 confirmatory method. Representative data follow. A Four Parameter Logistics Fit Method (4PLC, Y weighted) is used to generate the AxSYM Amphetamine/Methamphetamine II standard Added Concentration Concentration calibration curve. The calibration curve is stored in memory and Concentration in Urine in Solution 4 Percent (%) concentrations of drug in controls and unknown samples are calculated (ng/mL) (ng/mL) (ng/mL) Recovery from this curve using polarization values generated. 150.00 159.28 138.07 86.68 Alternate Result Units 300.00 301.90 285.49 94.56 The default result unit for AxSYM Amphetamine/Methamphetamine II is ng/mL. When selecting the alternate result unit μmol/L, the conversion 500.00 510.27 508.19 99.59 factor used by the AxSYM System is 0.0074. When selecting the alternate 1000.00 963.81 950.73 98.64 result unit μg/mL, the conversion factor used by the AxSYM System is 0.001. 1500.00 1569.44 1488.32 94.83 Flags 3000.00 3014.13 3243.96 107.63 Some results may contain information in the Flags field. For a description 4000.00 4048.28 4065.13 100.42 of the flags that may appear in this field, refer to the AxSYM System Operations Manual, Sections 1 and 2. 8000.00 7575.81 7702.10 101.67 Average Recovery = 98.0 ± 6.2% LIMITATIONS OF THE PROCEDURE Sensitivity As with all analyte determinations, the amphetamine/methamphetamine value should be used in conjunction with information available from The sensitivity of the AxSYM Amphetamine/Methamphetamine II assay clinical evaluation and other diagnostic procedures. was calculated to be 100.00 ng/mL. This sensitivity is defined as the Urine samples with a background intensity greater than the allowable lowest measurable concentration which can be distinguished from zero value are flagged with “Error Code 1065 Invalid test results, background with at least 95% confidence. intensity too high, (#).” These samples MUST NOT BE DILUTED AND RERUN. An alternate analysis method must be used on these samples.

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33B27-1C-20_Eng_ReIn.inddB27-1C-20_Eng_ReIn.indd 5 44/24/2008/24/2008 2:26:512:26:51 PPMM Specificity The following compounds do not cross-react above the sensitivity Cross-reactivity was tested for amphetamine, methamphetamine and (100.00 ng/mL) of the AxSYM Amphetamine/ Methamphetamine II assay amphetamine metabolites. The following compounds cross-react (Compounds tested at 100,000 ng/mL, unless otherwise indicated): above the sensitivity (100.00 ng/mL) of the AxSYM Amphetamine/ Acetaminophen Hydrocodone Methamphetamine II assay. Acetylsalicylic Acid Hydromorphone COMPOUND CONCENTRATION TESTED Albuterol * Ibuprofen (ng/mL) Alprazolam Isoproterenol d,l-Amphetamine 1,000 * l-Amphetamine 3,000 Amobarbital Ketoprofen 4-Chloroamphetamine 1,000 Amoxicillin Meperidine d-Methamphetamine 1,000 Ampicillin Methadone d,l-Methamphetamine 3,000 Aspartame Methadone Primary Benzocaine Metabolite (EDDP) l-Methamphetamine 8,000 Benzoic Acid 4-Methyl-2,5-dimethoxy- Benzoylecgonine Methylprylon amphetamine (DOM) 100,000 * Buprenorphine Morphine 3,4-Methylenedioxyamphetamine Butabarbital Naloxone (MDA) 3,000 Naltrexone 3,4-Methylenedioxy-N- Calcium Hypochlorite * Naproxen ethylamphetamine (MDE) 8,000 Chloramphenicol Niacinamide 3,4-Methylenedioxy- Chlordiazepoxide methamphetamine (MDMA) 3,000 Chloroquine Oxycodone Cross-reactivity was also tested with compounds that have similar Chlorpheniramine Oxymorphone chemical structure or are used concurrently. The following compounds Cholesterol * Penicillin G cross-react above the sensitivity (100.00 ng/mL) of the AxSYM * Ciprofloxacin Phenobarbital Amphetamine/Methamphetamine II assay. Clindamycin COMPOUND CONCENTRATION TESTED Phenylbutazone (ng/mL) Codeine * Benztropine Methanesulfonate 1,000,000 Diazepam Pipemidic Acid Benzylamine 1,000,000 Digoxin # Progesterone 1,000,000 Dihydrocodeine * Cyclohexylamine 1,000,000 Dihydromorphine ** 50,000 Diphenhydramine Quinine Fluoxetine 1,000,000 Ecgonine Salicylic Acid Isometheptene 50,000 ** Secobarbital 100,000 * Epinephrine Serotonin 100,000 * Erythromycin Sulindac Estriol Tetracycline 100,000 * Fenoprofen # 11-Nor-delta-9-THC-9- 100,000 * Furosemide carboxylic Acid 5-Methoxytryptamine 100,000 Gentisic Acid Metoprolol 1,000,000 Glutethimide Tolbutamide Mexiletine 100,000 * Guaiacol Glyceryl Ether Norfloxacin 1,000,000 Nylidrin 100,000 * Histamine Trimethoprim Ofloxacin 1,000,000 Hydralazine 100,000 # Tested at 10,000 ng/mL 100,000 * Tested at 1,000,000 ng/mL 10,000 ** Tested at 3,000,000 ng/mL Phenyltoloxamine 1,000,000 Interference 10,000 The compounds listed below, added to human urine, resulted in less than Ranitidine 1,000,000 10% error in detecting drug when assayed with the AxSYM Amphetamine/ 1,000,000 Methamphetamine II assay. Sertraline 1,000,000 Timolol 1,000,000 Compound Concentration Tested Trimethobenzamide 100,000 100,000 Acetone 1 g/dL 100,000 Ascorbic Acid 1.5 g/dL Bilirubin 0.25 mg/dL Creatinine 500 mg/dL Ethanol 1 g/dL Glucose 2 g/dL Hemoglobin (lysed red blood cells) 115 mg/dL Oxalic Acid 100 mg/dL Riboflavin 2 mg/dL Sodium Chloride 6 g/dL Total Protein 0.05 g/dL Urea 6 g/dL

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33B27-1C-20_Eng_ReIn.inddB27-1C-20_Eng_ReIn.indd 6 44/24/2008/24/2008 2:26:522:26:52 PPMM The presence of detergents in samples potentially interferes with BIBLIOGRAPHY immunoassay results. 1. Hawks RL. Analytical Methodology. In: Chiang CN, Hawks RL, eds. Bleach (hypochlorite) is a strong oxidizing agent. As a consequence, Urine testing for drugs of abuse. National Institute on Drug Abuse bleach may cause oxidation of some analytes, thus reducing the amount (NIDA). Research Monograph 73. Rockville, MD: Department of available for analysis. This may result in lower analytic results, regardless Health and Human Services, 1986; 35-8. of the methodology.12 2. Smith DE, Wesson DR, Buxton ME, Seymour RB, Ungerleider JT, There is the possibility that other substances and/or factors not listed Morgan JP, Mandell AJ, Jara G. Amphetamine use, misuse, and above may interfere with the test and cause false results. abuse: Proceedings of the National Amphetamine Conference. 1978. Accuracy By Correlation with Reference Assays Boston, MA: GK Hall & Co., 1979:3-17. The AxSYM Amphetamine/Methamphetamine II assay was evaluated 3. Baselt RC, Cravey RH. Disposition of toxic drugs and chemicals in for concordance to TDx and GC/MS by assaying drug-free and drug man. 4th Edition. Foster City, CA: Chemical Toxicology Institute, containing urine samples for amphetamine and methamphetamine. 1995:44-7,475-7. Samples were analyzed on-site at Abbott Laboratories on AxSYM and 4. US Department of Labor, Occupational Safety and Health TDx. GC/MS analysis of these samples was performed at a reference Administration, 29 CFR Part 1910.1030, Occupational Exposure to laboratory in Tennessee. Concordance is related to selected cut-off. The Bloodborne Pathogens. performance of AxSYM Amphetamine/Methamphetamine II assay was 5. US Department of Health and Human Services. Biosafety in evaluated at several cut-off levels (cut-off is the level above which the Microbiological and Biomedical Laboratories. 5th ed. Washington, AxSYM flags a sample as positive for the desired analyte). The cut-off for DC: US Government Printing Office; January 2007. GC/MS methodology is chosen by the reference laboratory. 6. World Health Organization. Laboratory Biosafety Manual. 3rd ed. TP+TN Geneva: World Health Organization; 2004. % Concordance = 100 x 7. Clinical and Laboratory Standards Institute. Protection of Laboratory TP+FP+TN+FN Workers from Occupationally Acquired Infections: Approved TP = True positives Guideline - Third Edition. CLSI Document M29-A3. Wayne, TN = True negatives PA: Clinical and Laboratory Standards Institute, 2005. FP = False positives 8. National Institute on Drug Abuse and Department of Health and FN = False negatives Human Services. The NIDA Guidelines. Subpart B, Section 2.4 (c, h). Federal Register, Vol. 59, No. 110, 9 June 1994: 29921-22. 300 ng/mL n=175 TDx Pos* TDx Neg GC/MS Pos GC/MS Neg 9. NCCLS. Urine Drug Testing in the Clinical Laboratory; Approved AxSYM Pos 173 0 174 0 Guideline. NCCLS document T/DM8-A (ISBN 1-56238-197-0). NCCLS, Wayne, PA, 1999:17. AxSYM Neg 0 1 0 1 10. Baselt RC. Urine drug screening by immunoassay: Interpretation of % CONCORDANCE results. In: Baselt RC, ed. Advances in analytical toxicology. Foster AxSYM vs. TDx = 100% City, CA: Biomedical Publications, 1984; Vol. 1: 81-123. AxSYM vs. GC/MS = 100% 11. NCCLS. Evaluation of precision performance of clinical 1000 ng/mL n=175 TDx Pos* TDx Neg GC/MS Pos GC/MS Neg chemistry devices; Approved Guideline. NCCLS Document EP5-A (ISBN 1-56238-368-X). NCCLS, Wayne, PA, 1999. AxSYM Pos 158 1 160 0 12. Fieser, LF, Fieser M. Reagents for Organic Synthesis. New York: AxSYM Neg 0 15 14 1 John Wiley & Sons, Inc., 1967-1984: Vols. 1-11. % CONCORDANCE AxSYM vs. TDx = 99% AxSYM, REA, TDx and XSYSTEMS are trademarks of Abbott Laboratories, AxSYM vs. GC/MS = 92% Abbott Park, IL, 60064 USA. 3000 ng/mL n=175 TDx Pos* TDx Neg GC/MS Pos GC/MS Neg ABBOTT AxSYM Pos 128 1 130 0 Max-Planck-Ring 2 AxSYM Neg 3 42 44 1 65205 Wiesbaden Germany % CONCORDANCE +49-6122-580 AxSYM vs. TDx = 97% AxSYM vs. GC/MS = 75% Manufactured for 8000 ng/mL n=175 TDx Pos* TDx Neg GC/MS Pos GC/MS Neg Abbott Laboratories, Abbott Park IL AxSYM Pos 105 0 106 0 by Abbott Diagnostics International, LTD. Barceloneta, Puerto Rico AxSYM Neg 8 61 68 1 % CONCORDANCE April, 2008 AxSYM vs. TDx = 95% AxSYM vs. GC/MS = 61% ©1995, 2008 Abbott Laboratories * Result on one TDx sample was not reportable because Blank I exceeded the maximum allowable background. AxSYM “Positive” = Concentration greater than or equal to the cut-off, 300, 1000, 3000 or 8000 ng/mL of d-Amphetamine TDx “Positive” = Concentration greater than or equal to the cut-off, 300, 1000, 3000 or 8000 ng/mL of d-Amphetamine GC/MS “Positive” = Concentration greater than or equal to 100 ng/mL of amphetamine or methamphetamine

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