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The ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card are rapid lateral flow immunoassays for the qualitative detection of 6-Acetylmorphine, d-Amphetamine, Benzoylecgonine, EDDP, d/1-Methadone, d-Methamphetamine, d/Methylenedioxymethamphetamine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: | Analyte | Calibrator | Cutoff (ng/mL) | |------------------|----------------------------------------------------|----------------| | 6-Acetylmorphine | 6-monoacetylmorphine | 10 | | Amphetamine | d-Amphetamine | 500 | | Amphetamine | d-Amphetamine | 1,000 | | Secobarbital | Secobarbital | 300 | | Oxazepam | Oxazepam | 300 | | Buprenorphine | Buprenorphine | 10 | | EDDP | 2-ethylidene-1,5-dimethyl-3-3- diphenylpyrrolidine | 300 | | Cocaine | Benzoylecgonine | 150 | | Cocaine | Benzoylecgonine | 300 | | Ecstasy | d,l-Methylenedioxymethamphetamine | 500 | | Methamphetamine | d-Methamphetamine | 500 | | Methamphetamine | d-Methamphetamine | 1,000 | | Marijuana | 11-nor-Δ9-THC-9-COOH | 20 | | Marijuana | 11-nor-Δ9-THC-9-COOH | 50 | | Methadone | d/l-Methadone | 300 | | Opiates | Morphine | 300 | | Opiates | Morphine | 2,000 | | Oxycodone | Oxycodone | 100 | | Phencyclidine | Phencyclidine | 25 | | Propoxyphene | Propoxyphene | 300 | | Nortriptyline | Nortriptyline | 1,000 | The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 16 analytes, with and without on-board adulteration/specimen validity tests (SVT) in the cup format. The drug screen tests are intended for prescription use only. The tests provide only a preliminary result. To obtained a confirmed analytical result, a more specific alternative chemical method should be used. Gas Chromatography / Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

For prescription use, the devices consist of: - a. 10 or 25 test cups or dip cards with or without adulteration/specimen validity tests - b. Package Insert - c. Procedure Card

The ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card are rapid lateral flow immunoassays for the qualitative detection of 6-Acetylmorphine, d-Ampletamine, Benzoylecgonine, EDDP, d/1-Methadone, d-Methamphetamine, d/Methylenedioxymethamphetamine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: | Analyte | Calibrator | Cutoff (ng/mL) | |---------------------------|----------------------------------------------------|----------------| | 6-Acetylmorphine | 6-monoacetylmorphine | 10 | | Amphetamine | d-Amphetamine | 500 | | Amphetamine | d-Amphetamine | 1,000 | | Barbiturates | Secobarbital/Pentobarbital | 300 | | Benzodiazepines | Oxazepam | 300 | | Buprenorphine | Buprenorphine | 10 | | EDDP | 2-ethylidene-1,5-dimethyl-3-3- diphenylpyrrolidine | 300 | | Cocaine | Benzoylecgonine | 150 | | Cocaine | Benzoylecgonine | 300 | | Ecstasy | d,l-Methylenedioxymethamphetamine | 500 | | Methamphetamine | d-Methamphetamine | 500 | | Methamphetamine | d-Methamphetamine | 1,000 | | Marijuana | 11-nor-Δ9-THC-9-COOH | 50 | | Methadone | d/l-Methadone | 300 | | Opiates | Morphine | 300 | | Opiates | Morphine | 2,000 | | Oxycodone | Oxycodone | 100 | | Phencyclidine | Phencyclidine | 25 | | Propoxyphene | Propoxyphene | 300 | | Tricyclic Antidepressants | Nortriptyline | 1,000 | The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 16 analytes, with and without on-board adulteration/specimen validity tests (SVT) in the cup format. The drug screen tests are intended for prescription use only. The tests provide only a preliminary result. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive positive result if the donor doesn't admit use or anytime required by testing procedures. Gas Chromatography / Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

For professional use, the devices consist of: - a. 10 or 25 test cups or dip cards with or without adulteration/specimen validity tests - b. Package insert - c. Procedure Card

The Advin Multi-Drug Screen Test is a one-step immunoassay for the qualitative detection of multiple drugs of abuse and/or their metabolites in human urine at the following cutoff levels: Amphetamine (AMP) Calibrator: d-Amphetamine, Cutoff Level: 500 ng/mL Barbiturates (BAR) Calibrator: Secobarbital, Cutoff Level: 300 ng/mL Benzodiazepines (BZO) Calibrator: Oxazepam, Cutoff Level: 300 ng/mL Buprenorphine (BUP) Calibrator: Buprenorphine, Cutoff Level: 10 ng/mL Cocaine (COC) Calibrator: Benzoylecgnine, Cutoff Level: 150 ng/mL EDDP Calibrator: 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Cutoff Level: 300 ng/mL Ecstasy (MDMA) Calibrator: Methylenedioxymethamphetamine, Cutoff Level: 500 ng/mL Methamphetamine (MET) Calibrator: d-Methamphetamine, Cutoff Level: 500 ng/mL Methadone (MTD) Calibrator: Methadone, Cutoff Level: 300 ng/mL Morphine (MOR300) Calibrator: Morphine, Cutoff Level: 300 ng/mL Opiates (OPI) Calibrator: Morphine, Cutoff Level: 2,000 ng/mL Oxycodone (OXY) Calibrator: Oxycodone, Cutoff Level: 100 ng/mL Phencyclidine (PCP) Calibrator: Phencyclidine, Cutoff Level: 25 ng/mL Propoxyphene (PPX) Calibrator: Propoxyphene, Cutoff Level: 300 ng/mL Tricyclic-antidepressant (TCA) Calibrator: Nortriptynine, Cutoff Level: 1,000 ng/mL Marijuana (THC) Calibrator: 11-nor-Δ9-THC-9-COOH, Cutoff Level: 50 ng/mL The Advin Multi-Drug Screen Test consists of three formats: a Cassette, a Dip Card and a Cup, which may be configured in any combination of the drug analytes listed in the above table. Advin Multi-Drug Screen Test is used to obtain a visual, qualitative, preliminary test result for prescription use in point of care sites, laboratory settings and is also intended for workplace and over-the-counter use. The Propoxyphene test strip is not intended for over-the-counter use. The Advin Multi-Drug Screen Test will yield preliminary positive results when prescription drugs TCA, Barbiturates and Benzodiazepine, Methadone, Buprenorphine and Opiates are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for TCA, Barbiturates and Benzodiazepine in urine. The Advin Multi-Drug Screen Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical test result. Gas chromatography/mass spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry/Mass (LC/MS/MS) and High Performance Liquid Chromatography-(HPLC)-are the-preferred-confirmatory-methods-Glinical-consideration and professional judgment should be applied to any drug of abuse test result, particularly in the evaluation of a preliminary positive test result.

The Advin Multi-Drug Screen Test is a lateral flow immunochromatographic competitive binding assay and is intended for prescription use, CLIA Waived use and OTC use. It is used as in vitro diagnostics to visually and qualitatively detect some of the most common drugs of abuse and/or their metabolites in human urine specimens. The test is based on the principle of competitive binding antigen-antibody immunochemistry. It utilizes anti-drug antibody to selectively detect elevated levels of multi-drugs and/or their metabolites in urine at a specified cutoff for each drug. These visual read tests are performed without the use of an instrument. A drug-Positive urine specimen will not generate a colored-line in the designated test region, while a drug-Negative urine specimen or a urine specimen containing drug(s) at the concentration below the cut-off level will generate a colored-line in the test region. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of urine specimen has been added and membrane wicking has occurred. Some of the Advin Multi-Drug Screen Test will be sold with either one or two adulteration test strips for the detection of adulterants added to the urine specimen. Each Adulteration strip consists of one to three reagent pads which consist of tests for oxidant, specific gravity, pH, glutaraldehyde, creatinine and nitrite.