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The Chemtrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Norfentanyl, Marijuana, Methamphetamine, Morphine, Opiates, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene , Tramadol and Trivyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the tests are calibrated to are as follows: The multi test panels can consist of any analytes listed above in any combination. Only one cut-off concentration will be included per analyte per device. The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. The Chemtrue® Drug Screen Fentanyl / Tramadol Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Norfentanyl 5 and Tramadol 100 drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: The Chemtrue® Drug Screen Fentany! / Tramadol Dip Card Test detects and is calibrated against norfentanyl, the major metabolite of fentanyl in human urine. The test is available in Single and multi-panels. The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The test is not intended to differentiate between drugs of abuse and prescription use of Fentanyl/ Tramadol. The test is for in vitro diagnostic use only. The Chemtrue® Drug Screen Fentanyl / Tramadol Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Norfentanyl 5 and Tramadol 100 drugs in human urine. It is an in vitro diagnostic device. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: The Chemtrue® Drug Screen Fentany1 / Tramadol Cup Test detects and is calibrated against norfentany1, the major metabolite of fentanyl in human urine. The test is available in Single and multi-panels. The test provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to the drug test result, particularly when preliminary positive result is indicated. The test is not intended to differentiate between drugs of abuse and prescription use of Fentany/ Tramadol. The test is for in vitro diagnostic use only. The Chemtrue® Multi-Panel Drug Screen Dip Card Test is a rapid lateral flow immunoassay for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Ecstasy, Norfentany, Marijuana, Methadone, Morphine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, Tramadol and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: The multi test panels can consist of any drug analytes listed above in any combination. Only one cutoff concentration will be included per analyte per device. The test provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Benzodiazepines, Antidepressants. The Chemtrue® Multi-Panel Drug Screen Cup Test is a rapid lateral flow immunoassay for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Ecstasy, Norfentanyl, Marijuana, Methamphetamine, Morphine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, Tramadol and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: The multi test panels can consist of any drug analytes listed above in any combination. Only one cutoff concentration will be included per analyte per device. The test provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Tricyclic Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Antidepressants.

The Chemtrue® Drug Screen Tests are colloidal gold-based lateral flow immunoassays for the rapid, qualitative detection of drugs of abuse in human urine. The tests are single-use, in vitro diagnostic devices, which come in Dip Card or Cup formats, as indicated by the test name.

The Chemitrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunossays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: | Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) | |------------------------------|--------------|---------------------------------------|------------------------------| | Amphetamine | AMP | d-Amphetamine | 300 | | Amphetamine | AMP | d-Amphetamine | 500 | | Amphetamine | AMP | d-Amphetamine | 1000 | | Barbiturates | BAR | Secobarbital/Pentobarbital | 200 | | Barbiturates | BAR | Secobarbital/Pentobarbital | 300 | | Benzodiazepines | BZO | Oxazepam | 200 | | Benzodiazepines | BZO | Oxazepam | 300 | | Buprenorphine | BUP | Buprenorphine | 10 | | Cocaine | COC | Benzoylecgonine | 150 | | Cocaine | COC | Benzoylecgonine | 300 | | Ecstasy | MDMA | d,l-Methylenedioxy<br>methamphetamine | 500 | | Methamphetamine | MAMP | d-Methamphetamine | 300 | | Methamphetamine | MAMP | d-Methamphetamine | 500 | | Methamphetamine | MAMP | d-Methamphetamine | 1000 | | Marijuana | THC | 11-nor-Δ9-THC-9-COOH | 50 | | Methadone | MTD | Methadone | 300 | | Opiates | OPI | Morphine | 2000 | | Oxycodone | OXY | Oxycodone | 100 | | Phencyclidine | PCP | Phencyclidine | 25 | | Propoxyphene | PPX | Propoxyphene | 300 | | Tricyclic<br>Antidepressants | TCA | Nortriptyline | 1000 | The multi test panels can consist of up to fourteen (14) of the above issed analytes in any combination. Only one cutoff concentration will be included per analyte per device. The tests are intended for prescription and Over-The-Counter (OTC) use. The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GCMS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodizepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

The Chemtrue® Drug Screen Tests are colloidal gold based lateral flow immunoassays for the rapid, qualitative detection of drugs of abuse in human urine. The tests are single-use, in vitro diagnostic devices, which come in Dip Card or Cup formats, as indicated by the test name.

The Chemtrue® Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Morphine 300, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: | Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) | |------------------------------|--------------|-----------------------------------|------------------------------| | Buprenorphine | BUP | Buprenorphine | 10 | | Tricyclic<br>Antidepressants | TCA | Nortriptyline | 1000 | | Amphetamine | AMP | d-Amphetamine | 1000 | | Cocaine | COC | Benzoylecgonine | 300 | | Methamphetamine | MAMP | d-Methamphetamine | 1000 | | Morphine | MOR | Morphine | 300 | | Phencyclidine | PCP | Phencyclidine | 25 | | Marijuana | THC | 11-nor-Δ9-THC9 COOH | 50 | | Benzodiazepines | BZO | Oxazepam | 300 | | Barbiturates | BAR | Secobarbital/Pentobarbital | 300 | | Ecstasy | MDMA | d,l-Methylenedioxymethamphetamine | 500 | | Methadone | MTD | Methadone | 300 | | Oxycodone | OXY | Oxycodone | 100 | The Chemtrue® Drug Screen Cup Tests panel can consist of any combination of the above listed drug analytes. The tests are intended for prescription and Over-The-Counter (OTC) use. The tests provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Buprenorphine, Oxycodone and Tricyclic Antidepressants. There are no uniformly recognized cutoff concentration levels for these drugs in urine. The Chemtrue Drug Screen Cup Tests with OPI 2000 are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Marijuana, Opiates 2000, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: | Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) | |-----------------|--------------|-----------------------------------|------------------------------| | Buprenorphine | BUP | Buprenorphine | 10 | | Tricyclic | | | | | Antidepressants | TCA | Nortriptyline | 1000 | | Amphetamine | AMP | d-Amphetamine | 1000 | | Cocaine | COC | Benzoylecgonine | 300 | | Methamphetamine | MAMP | d-Methamphetamine | 1000 | | Opiates 2000 | MOR | Morphine | 2000 | | Phencyclidine | PCP | Phencyclidine | 25 | | Marijuana | THC | 11-nor-Δ9-THC9 COOH | 50 | | Benzodiazepines | BZO | Oxazepam | 300 | | Barbiturates | BAR | Secobarbital/Pentobarbital | 300 | | Ecstasy | MDMA | d,l-Methylenedioxymethamphetamine | 500 | | Methadone | MTD | Methadone | 300 | | Oxycodone | OXY | Oxycodone | 100 | The Chemtrue Drug Screen Cup Tests with OPI 2000 panel can consist of any combination of the above listed drug analytes. The tests are intended for prescription and Over-The-Counter (OTC) use. The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodizzepines, Buprenorphine, Oxycodone and Tricyclic Antidepressants. There are no uniformly recognized cutoff concentration levels for these drugs in urine.

The Chemtrue® Drug Screen Cup Tests are colloidal gold based lateral flow immunoassays for the rapid, qualitative detection of drugs of abuse in human urine. The tests are single-use, in vitro diagnostic devices, which come in the Cup format, as indicated by the test name.

Chemtrue® Multi-Panel DOA Dip Card Tests: The Chemtrue® Multi-Panel DOA Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Morphine, Methamphetamine, Phencyclidine, Benzodiazepines, Ecstasy, Methadone and Oxycodone drugs in human urine. The test cut-off concentrations and the tests are calibrated to are as follows: | Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) | |-----------------|--------------|-----------------------------------|------------------------------| | Amphetamine | AMP | d-Amphetamine | 1000 | | Cocaine | COC | Benzoylecgonine | 300 | | Methamphetamine | MAMP / MET | d-Methamphetamine | 1000 | | Morphine | MOR | Morphine | 300 | | Phencyclidine | PCP | Phencyclidine | 25 | | Marijuana | THC | 11-nor-Δ9-THC9-COOH | 50 | | Benzodiazepines | BZO | Oxazepam | 300 | | Barbiturates | BAR | Secobarbital/Pentobarbital | 300 | | Ecstasy | MDMA | d,l-Methylenedioxymethamphetamine | 500 | | Methadone | MTD | Methadone | 300 | | Oxycodone | OXY | Oxycodone | 100 | The Chemtrue® Multi-Panel DOA Dip Card Tests panel can consist of any combination of the above listed drug analytes. The tests are intended for prescription and Over-The-Counter (OTC) use. The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the prefered confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates and Oxycodone. There are no uniformly recognized cut-off concentration levels for these drugs in urine. Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests: The Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Opiates 2000, Methamphetamine, Phencyclidine, Benzodiazepines. Barbiturates, Ecstasy, Methadone and Oxycodone drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: | Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) | |-----------------|--------------|-------------------|------------------------------| | Amphetamine | AMP | d-Amphetamine | 1000 | | Cocaine | COC | Benzoylecgonine | 300 | | Methamphetamine | MAMP /MET | d-Methamphetamine | 1000 | | Opiates | OPI | Morphine | 2000 | | Phencyclidine | PCP | Phencyclidine | 25 | | Marijuana | THC | 11-nor-Δ9-THC9-COOH | 50 | | Benzodiazepines | BZO | Oxazepam | 300 | | Barbiturates | BAR | Secobarbital/Pentobarbital | 300 | | Ecstasy | MDMA | d,l-Methylenedioxymethamphetamine | 500 | | Methadone | MTD | Methadone | 300 | | Oxycodone | OXY | Oxycodone | 100 | The Chemrue® Multi-Panel DOA Dip Card with OP1 2000 Tests can consist of any combination of the above listed drug analytes. The tests are intended for prescription and Over-The-Counter (OTC) use. The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GCMS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates and Oxycodone. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

The Chemtrue® DOA Tests are colloidal gold based lateral flow immunoassays for the rapid, qualitative detection of drugs of abuse in human urine. The tests are single-use, in vitro diagnostic devices, which come in the formats of dip card, cup, or cassette, as indicated by the test name.

The Chemtrue® BUP/TCA Single/Multi-Panel Drug Screen Dip Card /Cup/Cassette Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine (BUP) and/or Tricyclic Antidepressants (TCA) drugs in human urine. The tests are intended for prescription and Over-The-Counter (OTC) use. The tests provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to distinguish between prescription use or abuse of Buprenorphine and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for Buprenorphine and Tricvclic Antidepressants in urine. The Chemtrue® Multi-Panel Drug Screen Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Marijuana, Morphine, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants drugs in human urine. The tests are intended for prescription and Over-The-Counter (OTC) use. The tests provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Buprenorphine, Oxycodone and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine. The Chemtrue® Multi-Panel Drug Screen Dip Card with OPI 2000 Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Marijuana. Opiates 2000. Methamphetamine. Phencyclidine. Benzodiazepines. Barbiturates. Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants drugs in human urine. The tests are intended for prescription and Over-The-Counter (OTC) use. The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

The Chemtrue® Drug Screen Tests are colloidal gold based lateral flow immunoassays for the rapid, qualitative detection of drugs of abuse in human urine. The tests are single-use, in vitro diagnostic devices, which come in the formats of dip card, cup, or cassette, as indicated by the test name.

The Chemtrue® hCG Pregnancy Urine Midstream Test is a rapid lateral flow qualitative immunoassay for early detection of human chorionic gonadotropin (hCG) in human urine in the device format of Midstream. The test is designed to aid early detection of pregnancy by home users. The device is intended for Over-The-Counter (OTC) Use.

The device employs lateral flow immunoassay technology for detection of human chorionic gonadotropin (hCG) in urine. Monoclonal goat anti-hCG antibodies are pre-striped in the nitrocellulose membrane on the test region (T line) and goat antibodies on the control region (C line). During testing, the urine/serum specimen reacts with the conjugate pad (It contains colloidal gold particles conjugated with monoclonal anti-hCG antibody specific to the beta subunit of hCG) located just beneath the sample pad and above the membrane of the test strip. The specimen migrates upward on the membrane by capillary action to react with the antibodies on the membrane. If the hCG concentration in the specimen is at or above the designated detection limit, a red colored line at the test region will be present indicating a positive result, while its absence indicates a negative result. The control line (C line) serves as an internal quality control. The control line should always appear, regardless of the hCG concentration of the test specimen, and the C line is an indicator that sufficient sample volume has been added to the test device and the sample has correctly migrated up the test strip. The device is designed in Midstream format. Each device consists of one (1) individual test strip and each test strip in the device consists of: - 1) A conjugate pad contains colloidal gold conjugated with monoclonal anti-hCG antibody specific to the beta subunit of hCG. - 2) A nitrocellulose membrane which is striped with the specific goat anti-hCG in the test line (T line) and goat anti-mouse antibody in the control line (C line). Presence of this line indicates that the test is performed correctly. A test result is read at three (3) minutes and the cut-off of the device is 20 mIU/mL hCG. The Midstream Test kit consists of one test device in a foil pouch and a package insert.

The Chemtrue® hCG urine or Combo test is a rapid lateral flow immunoassay for the visual qualitative detection of human chorionic gonadotropin (hCG) in human urine or serum as an aid in the early determination of pregnancy. The Dipstick/Cassette and Combo Tests are for prescription use only, including at physician's offices or other Point-Of-Care sites (POC).

The Chemtrue® hCG urine test is designed in Dipstick and Cassette formats. The hCG Combo (Serum/Urine) test is available in Cassette format only. Each test device consists of one (1) individual test strip and each test strip in the device consists of: 1) A conjugate pad contains colloidal gold conjugated with monoclonal anti-hCG antibody specific to the beta subunit of hCG. 2) A nitrocellulose membrane which is striped with the specific goat anti-hCG in the test line (T line) and goat anti-mouse antibody in the control line (C line serves as an internal quality control of the system and appears as a colored band during the test regardless of the hCG level in the test sample. All the configurations have the same membrane format, reagents and gold conjugate pad, as well as the same flow characteristics, except the test line in the nitrocellulose membrane for hCG Combo test is striped with polyclonal goat anti-hCG antibodies. Devices are packaged one device per foil pouch and 25 devices in each kit.

The Chemtron Biotech, Inc.'s Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of up to six of the following drugs in a variety of combinations in human urine. The designated cutoff concentrations of each drug and the calibrators used for these drugs are as follows: Analyte Abbreviation Calibrator Cutoff Concentration Benzodiazepines BZO Oxazepam 300 ng/mL Barbiturates BAR Secobarbital/Pentobarbital 300 ng/mL Ecstasy MDMA/XTC d,l-Methylenedioxymethamphetamine 500 ng/mL Methadone MTD Methadone 300 ng/mL Opiates OPI/MOR Morphine 2000 ng/mL Oxycodone OXY Oxycodone 100 ng/mL The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are intended for the qualitative detection of drugs of abuse for health care professionals, in vitro diagnostic and Over-The-Counter (OTC) use. The BAR.BZO and OXY assay will yield preliminary positive results when BAR, BZO, and OXY is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepine and Oxycodone in urine. The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Div Card Tests shows the drug was or was not present at the cutoff level. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method for most drugs (HPLC is the preferred confirmatory method for tri-cyclic antidepressants). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The Drugs of Abuse (DOA) Screen Panels are one-step lateral flow immunoassays in which chemically labeled drugs (drug-protein conjugates) compete for limited antibody binding sites with drugs that may be present in urine. The test device consists of up to six test strips placed in separate panels of a plastic holder. On each test strip, a drug-protein conjugate is striped on the test band of the membrane - known as the test region (T) and the drug antibody-colloidal gold conjugate pads are placed at one end of the membrane (opposite in morphine). In the absence of drugs in the urine, the solution of the colored antibody-colloidal gold conjugates move along with the sample solution upward chromatographically by capillary action across the membrane to the immobilized drug-protein conjugate zones on the test band region. The colored antibody-gold conjugates then complexes with the drug-protein conjugates to form visible lines. Therefore, the formation of the visible precipitant in the test band occurs when the test urine is negative for the drug. If any drug is present in the urine, the drug/metabolite antigen competes with the drugprotein conjugates on the test band region for the limited antibody on the colored drug antibodycolloidal gold conjugate pad. When a sufficient amount of drug is present in the urine, the drug will saturate the limited antibody binding sites and the colored antibody-colloidal gold conjugate cannot bind to the drug-protein conjugate at the test strip. Therefore, absence of the color band on the test region indicates a preliminary positive result. A control band with a different antigen/antibody reaction is added to the membrane strip at the control region (C) to indicate that the test has performed properly. This control line is manufactured as a built-in internal control of the test device and should always appear regardless of the presence of drug or metabolite. If the control line does not appear the test cassette should be discarded. The presence of this colored band in the control region also serves 1) as verification that adequate specimen volume is added (flooding, if too much urine is added, or no flow, due to insufficient urine volume), 2) the test device is properly functioning, and 3) as reagent control.

The Chemtron Biotech, Inc.'s Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of up to six of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and the calibrators used for these drugs are as follows: Analyte Abbreviation Calibrator Cutoff Concentration Amphetamine AMP d-Amphetamine 1000 ng/mL Cocaine COC Benzoylecgonine 300 ng/mL Marijuana THC 11-nor-Δ9-THC9-COOH 50 ng/mL Methamphetamine MET d-Methamphetamine 1000 ng/mL Opiates OPI/MOR Morphine 300 ng/mL Phencyclidine PCP Phencyclidine 25 ng/mL The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are intended for the qualitative detection of drugs of abuse for health care professional, in vitro diagnostic and Over-the-Counter (OTC) use. These assays provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The Drugs of Abuse (DOA) Screen Panels are one-step lateral flow immunoassays in which chemically labeled drugs (drug-protein conjugates) compete for limited antibody binding sites with drugs that may be present in urine. The test device consists of up to six test strips placed into separate panels of a plastic holder. On each test strip, a drug-protein conjugate is striped on the test band of the membrane - known as the test region (T) and the drug antibody-colloidal gold conjugate pads are placed at one end of the membrane (opposite in morphine). In the absence of drugs in the urine, the solution of the colored antibody-colloidal gold conjugates move along with the sample solution upward chromatographically by capillary action across the immobilized drug-protein conjugate zones on the test band region. The colored antibody-gold conjugates then complexes with the drug-protein conjugates to form visible lines. Therefore, the formation of the visible precipitant in the test band occurs when the test urine is negative for the drug. If any drug is present in the urine, the drug/metabolite antigen competes with drug-protein conjugates on the test band region for the limited antibody on the colored drug antibody-collooidal gold conjugate pad. When a sufficient amount of drug is present in the urine, the drug will saturate the limited antibody binding sites and the colored antibody -colloidal gold conjugate cannot bind to the drug-protein conjugate at the test region of the test strip. Therefore, absence of the color band on the test region indicates a preliminary positive result. A control band with a different antibody reaction is added to the membrane strip at the control region (C) to indicate that the test has performed properly. This control line is manufactured as a builtin internal control of the test device and should always appear regardless of the presence of drug or metabolite. If the control line does not appear the test cassette should be discarded. The presence of this colored band in the control region also serves 1) as verification that adequate specimen volume is added (flooding, if too much urine is added, or no flow, due to insufficient urine volume), 2) the test device IS properly functioning, and 3) as reagent control.

The Chemtron Biotech, Inc.'s Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of up to six of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and the calibrators used for these drugs are as follows: | Analyte | Abbreviation | Calibrator | Cutoff Concentration | |-----------------|--------------|-----------------------------------|----------------------| | Benzodiazepines | BZO | Oxazepam | 300 ng/mL | | Barbiturates | BAR | Secobarbital/Pentobarbital | 300 ng/mL | | Ecstasy | MDMA/XTC | d,I-Methylenedioxymethamphetamine | 500 ng/mL | | Methadone | MTD | Methadone | 300 ng/mL | | Opiates | OPI/MOR | Morphine | 2000 ng/mL | | Oxycodone | OXY | Oxycodone | 100 ng/mL | The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are intended for the qualitative detection of drugs of abuse for in vitro diagnostic and prescription use ONLY. They are not intended for point-of-care settings or over the counter use. These assays provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The Drugs of Abuse (DOA) Screen Panels are one-step lateral flow immunoassays in which chemically modified drugs (drug-protein conjugates) compete for limited antibody binding sites with drugs that may be present in urine. The test device consists of up to six test strips placed into separate panels of a plastic holder. On each test strip, a drug-protein conjugate is striped on the test band of the membrane - known as the test region (T) and the anti-drug antibody-colloidal gold conjugate pads are placed at the forward end of the membrane.