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The Applied DNA Technologies Bionexia™ DOA Panels are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to thirteen of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows: | Analyte | Abbreviation | Calibrator | Cutoff Concentration | |-----------------|--------------|-------------------------------------------------------|----------------------| | Amphetamine | AMP | Amphetamine | 1000 ng/ml | | Barbiturate | BAR | Secobarbital | 300 ng/ml | | Benzodiazepines | BZO | Oxazepam | 300 ng/ml | | Cocaine | COC | Benzoylecgonine | 300 ng/ml | | Marijuana | THC | 11-nor- $\Delta^{9}$ -THC9-COOH | 50 ng/ml | | Methamphetamine | MET | Methamphetamine | 1000 ng/ml | | Methadone | MTD | Methadone | 300 ng/ml | | Morphine | MOR | Morphine | 2000 ng/ml | | Morphine | MOR | Morphine | 300 ng/ml | | Phencyclidine | PCP | Phencyclidine | 25 ng/ml | | Nortriptyline | NOR | Nortriptyline | 1000 ng/ml | | Ecstasy | MDMA | 3,4-Methylenediioxy-MET | 500 ng/ml | | Buprenorphine | BUP | BUP-3-D-Glucuronide | 10 ng/ml | | EDDP | EDDP | 2-ethylidene-1,5-dimethyl-<br>3,3-diphenylpyrrolidine | 100 ng/ml | For health care professionals use including professionals at point of care sites (POC) to assist in the determination of drug compliance. This assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

One-step, colloidal gold based chromatographic immunoassay for the rapid, qualitative detection of Marijuana, Cocaine, Phencyclidine, Morphine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines, Nortriptyline, Ecstasy, Buprenorphine and Methadone metabolite -EDDP, in human urine.

The Applied DNA Technologies Bionexia™ hCG Pregnancy Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in urine to help in the early determination of pregnancy. The test kits are for health care professionals use including professionals at physician's office labs (POLs). For a final Diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

The Bionexia™ hCG Pregnancy Test will be distributed in both Cassette and Dipstick formats. Each test reagent strip contains mouse monoclonal anti-a-hCG antibody coated membrane and a dried chemical pad containing mouse monoclonal anti-ß-hCG anybody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG.

The Applied DNA Technologies Bionexia™ hCG Pregnancy Serum/Urine Cassette and Dipstick Tests are rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen to help in the early determination of pregnancy. The test kits are for health care professionals use including professionals at physician's office labs (POLs). For a final Diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

The Bionexia™ hCG Pregnancy Serum/Urine Test are distributed in both Cassette and Dipstick formats. Each test reagent strip contains mouse monoclonal anti-u-hCG antibody coated membrane and a dried chemical pad containing mouse monoclonal anti-ß-hCG anybody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG.

Applied DNA Technologies ACCUSTEP DOA Panels are rapid chromatographic The immunoassays for the qualitative and simultaneous detection of one to ten of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows: | Analyte | Abbreviation | Calibrator | Cutoff Concentration | |-----------------|--------------|-------------------------------|----------------------| | Amphetamine | AMP | Amphetamine | 1000 ng/ml | | Barbiturate | BAR | Secobarbital | 300 ng/ml | | Benzodiazepines | BZO | Oxazepam | 300 ng/ml | | Cocaine | COC | Benzoylecgonine | 300 ng/ml | | Marijuana | THC | 11-nor- $\Delta^9$ -THC9-COOH | 50 ng/ml | | Methamphetamine | MET | Methamphetamine | 1000 ng/ml | | Methadone | MTD | Methadone | 300 ng/ml | | Morphine | MOR | Morphine | 2000 ng/ml | | Phencyclidine | PCP | Phencyclidine | 25 ng/ml | | Nortriptyline | NOR | Nortriptyline | 1000 ng/ml | These test kits are intended for health care professional use only. This assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

One-step, colloidal gold based chromatographic immunoassay for the rapid, qualitative detection of Marijuana. Cocaine, Phencyclidine, Morphine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines and Nortriptyline, a Tricyclic Antidepressant, in human urine.