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Microsoft word - multi-drug 6-parameter _urine_ doac0006.doc

STORE AT 2 – 30°C ISO 13485 accredited company FOR IN-VITRO DIAGNOSTIC USE ONLY DOAC – MULTI-DRUG 6-PARAMETER DEVICE Page 1 of 3 MULTI-DRUG 6-PARAMETER The assay should not be used without proper supervision and is Fortress one Step Multi-6 Drug Test Panel is a one-step immunoassay in not intended for over the counter sales. which a chemically labeled drug (drug-protein conjugate) competes with the drug which may be present in urine for limited antibody Material Required But Not Provided: binding sites. The test device contains membrane strips which are pre- Specimen collection container coated with drug-protein conjugate (or antibody) on the test band. The colored antibodies (or drug-protein conjugate)-colloidal gold conjugate pads are placed at the end of the membrane. In the Specimen Collection: absence of drug in the urine, the solution of colored antibody (or Fortress one Step Multi-6 Drug Test Panel is formulated for use with Fortress one Step Multi-6 Drug Test Panel is a lateral flow, one-step drug-protein conjugate)-colloidal gold conjugate and urine moves urine specimens. Fresh urine does not require any special handing or panel immunoassay for the qualitative detection of Methadone, upward chromatographically by the capillary action across the pretreatment. Urine samples should be collected such that testing Methamphetamine, membrane. This solution then migrates to the immobilized drug- may be performed as soon as possible after the specimen collection, metabolite), Morphine, and 11-nor- tetrahydrocannol-9-carboxylic protein conjugate (or antibody) zone on the test band region. The preferably during the same day. The specimen may be refrigerated acid in human urine at the following cut-off concentrations. conjugate)-colloidal at 2-8°C for 2 days, or frozen at –20° C for a longer period of time. conjugate then attaches to the drug-protein conjugate (or antibody) Specimens that have been refrigerated must be equilibrated to room to form a visible line as the antibody complexes with the drug temperature prior to testing. Specimens previously frozen must be M-AMP Methamphetamine 1000ng/ml conjugate. Therefore, the formation of a visible precipitant in the test thawed, equilibrated to room temperature, and mixed thoroughly PCP Phencyclidine 25ng/ml zone occurs when the test urine is negative for the drug. When drug is prior to testing. COC Benzoylecgonine 300ng/ml present in the urine, the drug/metabolite antigen competes with MOR Morphine 300ng/ml drug-protein conjugate on the test band region for the limited Note: urine specimens, and all materials coming in contact with them, THC 11-nor-∆9-THC-9-COOH 50ng/ml antibody. When a sufficient concentration of drug is present, it will fill should be handled and disposed as if capable of transmitting the limited antibody binding sites. This will prevent attachment of the infection. Avoid contact with skin by wearing gloves and proper This assay provides only a preliminary analytical test result. A more conjugate)-colloidal laboratory attire. specific alternative chemical method must be used in order to obtain conjugate to the drug-protein conjugate (or antibody) zone on the a confirmed analytical result. Clinical consideration and professional test band region. Therefore, the absence of the color band on the judgment should be applied to any drug of abuse test result, test region indicates a positive result. Review "Specimen Collection" instructions. Test device, patient's particularly when preliminary positive results are indicated. samples, and controls should be brought to room temperature (20- A control band that has a different antigen/antibody reaction is 30°C) prior to testing. Do not open pouches until ready to perform the added to the immunochromatographic membrane strip at the control region (C) to indicate that the test has performed properly. Remove the test device from the protective pouch (bring the Within 8 minutes This control line should always appear regardless of the presence of device to room temperature before opening the pouch to avoid 24 months from date of production drug or metabolite. This means that negative urine will produces two condensation of moisture on the membrane) label the device colored bands, and positive urine will produce only one band. with patient or control identification. Immerse the sample strips in urine for about 10 seconds then place Urine based tests for drugs of abuse range from simple immunoassay the device on a flat surface (Approximately 50% of the sample test to complex analytical procedures. The speed and sensitivity of The test kit should be stored refrigerated or at room temperature strips should be immersed in the urine to obtain the appropriate immunoassays have made them the most widely accepted method 2-30oC (36-86°F) in the sealed pouch for the duration of the shelf-life. amount of sample for the test). Do not al ow urine to touch plastic for testing urine for drugs of abuse. device when immersing the sample strips. Warnings And Precautions: Read result within 3 to 8 minutes. Do not read results after 8 Fortress one Step Multi-6 Drug Test Panel is based on the principle of the FOR IN VITRO DIAGNOSTIC USE highly specific immunochemical reactions of antigens and antibodies For professional use only. which are used for the analysis of specific compounds in biological Urine specimens may be potentially infectious. Proper handling fluids. One Step Multi-6 Drug Test Panel is a rapid, visual, competitive and disposal methods should be established. panel immunoassay that can be used for the simultaneous, qualitative Avoid cross-contamination of urine samples by using a new methamphetamine, specimen collection container and specimen pipette for each benzoylecgonine (cocaine metabolite) morphine, and 11-nor- tetrahydrocannabinol-9-carboxylic acid in human urine. Fortress Diagnostics Limited, Unit 2C Antrim Technology Park, Antrim BT41 1QS (United Kingdom) TEL: +44 (0) 2894 487676 FAX: +44 (0) 2894 469933 www.Fortressdiagnostics.com

STORE AT 2 – 30°C ISO 13485 accredited company FOR IN-VITRO DIAGNOSTIC USE ONLY DOAC – MULTI-DRUG 6-PARAMETER DEVICE Page 2 of 3 One-Step Multi-6 The assay is designed for use with human urine only. (Positive/Negative) (Positive/Negative) A positive result with any of the tests indicates only the presence of a drug/metabolite and does not indicate or measure There is a possibility that technical or procedural errors as well other substances as factors not listed may interfere with the test and cause false results. See SPECIFICITY for lists of substances that will produce positive results, or that do not interfere with test If it is suspected that the samples have been mislabeled or tampered with, a new specimen should be collected and the test should be repeated. 11-nor-∆9-THC-9-COOH Quality Control: Good laboratory practice recommends the use of control materials to ensure proper kit performance. Quality control specimens are Precision: The precision of Fortress one Step Multi-6 Drug Test Panel available from commercial sources. When testing the positive and was determined by conducting the test with spiked controls. The negative controls, use the same assay procedure as with a urine control at the concentration of 50% below the cut-off should give a Interpretation Of Results: negative result and the control at the concentration of 50% above Negative: Two colored lines adjacent to each drug name should be the cut-off should give a positive result. observed in the viewing window. The line in the test region (T) is the drug Performance Characteristics: probe line; the line in the control region (C) is the control line, which is used Accuracy: The accuracy of One Step Multi-6 Drug Test Panel was Specificity: The specificity for One Step Multi-6 Drug Test Panel was to indicate proper performance of the device. The test line intensity may evaluated in comparison to a commercially available immunoassay. tested by adding various drugs, drug metabolites, and other be weaker or stronger than that of the control line. One hundred twenty (120) urine samples, collected from presumed compounds that are likely to be present in urine. All compounds were non-user volunteers, have been tested by both methods. Of these prepared in drug-free normal human urine. Positive: Only one colored line appears in the control region (C). The urine specimens tested, all were found negative by both methods absence of a test line indicates a positive result for that drug. (100% agreement on negative samples). The following structurally related compounds produced positive results when tested at levels equal to or greater than the concentrations Invalid: No line appears in the control region. Under no circumstances Approximately seventy (70) urine samples for each of five specific should a positive sample be identified until the control line (c) forms in drugs, obtained from a clinical laboratory where the concentrations the viewing area. If the control line (c) does not form, the test result is of drugs were determined by GC/MS, were tested with One Step Concentration(ng/ml) inconclusive and the assay should be repeated. Multi-6 Drug Test Panel and a commercially available immunoassay. The results are presented below: Note: A very faint line on the test region indicates that the drug in the Doxylamine 50,000 sample is near the cut-off level for the test. These samples should be re-tested or confirmed with a more specific method before a positive determination is made. Positive
Negative
Fortress Diagnostics Limited, Unit 2C Antrim Technology Park, Antrim BT41 1QS (United Kingdom) TEL: +44 (0) 2894 487676 FAX: +44 (0) 2894 469933 www.Fortressdiagnostics.com

STORE AT 2 – 30°C ISO 13485 accredited company FOR IN-VITRO DIAGNOSTIC USE ONLY DOAC – MULTI-DRUG 6-PARAMETER DEVICE Page 3 of 3 The fol owing compounds were found not to cross-react when tested at Concentration(ng/ml) concentrations up to 100 ug/ml For In Vitro Diagnostics Use Only d-Methamphetamine (+/-) –Isoproterenol Catalogue Number (1R, 2S)-(-)-N-Methyl- l-Methamphetamine (l-Deoxyephedrine) 25,000 Storage Temperature Expiry Date (Year / Month) β-Phenylethylamine Naphthalene acetic acid Warning, Read Enclosed Documents (+/-)-Norephedrine Instructions For Use (+)-Chlorpheniramine (+/-)-Chlorpheniramine Dexbrompheniramine Dextromethorphan Dimethylaminoantipyrine Hydromorphone 375 (+/-) –Ephedrine Trimethobenzamide (-) –Ephedrine (+) –Epinephrine 11-nor-∆9-THC-9-COOH 50 1. Baselt, R.C.Disposition of Toxic Drugs and Chemicals in Man, 11-nor-∆8-THC-COOH 50 Biomedical Publications, Davis CA, 1982. 2. Urine testing for Drugs of Abuse. National Institute on Drug Abuse (NIDA), Research Monograph 73, 1986. 3. Fed. Register, Department of Health and Human Services, Mandatory Guidelines for Federal Workplace Drug Testing Programs, 53, 69, 11970-11979, 1988. 4. McBay, A.J.Clin Chem.33, 33B-40B, 1987. 5. Gilmar, A.G., and Goodman, L.S. The Pharmacological Basis of Therapeutics, eds. MacMillan Publishing, New York, NY, 1980. Fortress Diagnostics Limited, Unit 2C Antrim Technology Park, Antrim BT41 1QS (United Kingdom) TEL: +44 (0) 2894 487676 FAX: +44 (0) 2894 469933 www.Fortressdiagnostics.com

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