Search Results

The Rapid TOX Cup II is an in vitro diagnostic drugs of abuse testing device intended for use in the qualitative detection of the following drugs of abuse testing in a human urine specimen: Amphetamines, Barbiturates (Butalbital), Benzodiazepines (Oxazepam), Buprenorphine, Cocaine, MDMA (Methylenedioxymethamphetamine), Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Marijuana, Tricyclic Antidepressants. The test is intended for over-the-counter use.

Rapid TOX Cup II is a drug test that can detect 1 to 13 drugs in human urine. Rapid TOX Cup II is collection cup with a temperature strip attached. It contains an insert with one or more test strips in the insert. Each test strip can test for up to 4 different drugs. The test is for over-the-counter or professional use. Rapid TOX CUP II is a first step in a 2-step process. The test provides information about the presence of certain drugs in urine. The second step in the process is more specific testing by a laboratory.

Rapid Tox Cup™ is a one-step, lateral flow immunoassay contained in a polypropylene cup for the simultaneous detection of abused drugs in urine. 'Rapid Tox Cup'- is intended for use in the qualitative detection of the following 14 drugs of abuse in human urine at the following levels: Amphetamine 1000 ng/mL Amphetamine 500 ng/mL Methamphetamine 1000 ng/mL Methamphetamine 500 ng/mL 3,4-methylenedioxymethamphetamine (MDMA) 1000 ng/mL 3,4-methylenedioxymethamphetamine (MDMA) 500 ng/mL Buprenorphine 12.5 ng/mL Benzodiazepines (Oxazepam) 300 ng/mL Barbiturates (Butalbital) 300 ng/mL Oxycodone 100 ng/mL Methadone 300 ng/mL Phencyclidine 25 ng/mL Propoxyphene 300 ng/mL Opiates 300 ng/mL Opiates 2000 ng/mL Cocaine (Benzoylecgonine) 300 ng/mL Cocaine (Benzoylecgonine) 150 ng/mL Tricyclic Antidepressants (Nortriptyiline) 1000 ng/mL THC/ Cannabinoids (11 nor△9-THC-9-carboxylic acid) 50 ng/mL 'Rapid Tox Cup' is intended for professional use. It is not intended for over-the-counter sale to non-professionals. This assay is a simplified screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas-chromatography/mass spectrometry (GC/MS). The barbiturate BAR, benzodiazepine BZO and tricyclic antidepressant TCA will yield preliminary positive results when BAR, BZO, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, or tricyclic antidepressant in urine. Certain foods or medicines may interfere with tests for Barbiturates, Benzodiazepines, and Tricyclic Antidepressants and may cause positive results. There is no calibration necessary and therefore no calibrator needed for this device. 'Rapid Tox Cup' provides only a preliminary analytical result. A more specific alternate method must be used in order to obtain a more confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse result, particularly when preliminary positive results are used.

The immunoassays employed in each test strip of the 'Rapid Tox Cup' are based on the same principle of the highly specific reaction between antigens and antibodies. Each assay consists of a membrane strip onto which up to five different drug conjugates have been immobilized. A colloidal gold-antibody complex consisting of up to five antibodies is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-multi-antibody complex moves with the urine sample by capillary action to contact the immobilized drug conjugate. Antibody-antigen reactions occur forming a visible line in all "test" areas. The formation of a visible line in the test areas occur when the test is negative for the adjacent labeled drug. When drug is present in the urine sample, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the limited antibody binding sites on the colloidal gold-labeled antibody complex, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a colored line in any of the test areas is indicative of a presumptive positive result. A control line, comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence or absence of a drug in the urine, and therefore, should be present in all reactions. A negative urine will produce up to six colored lines, and a positive sample will produce a colored line in the control area and no colored line(s) in the test area corresponding to the individual analyte(s) that are present in the sample. The device is contained in a polypropylene cup.

'RapidOne'-Buprenorphine Test is a one-step lateral flow immunoassay for the qualitative detection of 12.5 ng/ml of buprenorphine in human urine. 'RapidOne'-Buprenorphine Test is intended for professional use. It is not intended for over the counter sales to nonprofessionals. The assay to perform, but should not be used without proper supervision. The immunoassay is a simplified, qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. liquid chromatography/mass spectrometry (LC/MS). 'RapidOne'-Buprenorphine Test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a more confirmed result. LC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.

The assay employed in the "RapidOne"-Buprenorphine Test is based on the same principle of highly specific reactions between antigens and antibodies. This assay is a one-step, competitive, immunoassay for the detection of buprenorphine-and buprenorphine glucuronide in human urine. The test device consists of a membrane strip onto which a drug conjugate has been mobilized and a colloidal gold-antibody complex. is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine by capillary action to contact the immobilized drug conjugate. Antibody-antigen reactions occur, forming visible lines in the "test" area. When drug is present in the urine sample, the drug or metabolite will compete with the drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex. If sufficient amount of drug is present, it will fill all of the available antibody binding sites, thus preventing attachment of the labeled antibody to the drug compage. An absence of a color band (Ime) in the "test" grea is indicative of a possive result. A control band (line), comprised of a different autibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence of absence of drug in the urine, and therefore, should be present on all reactions. A negative will produce two colored bands, and a positive sample will produce only one band.

'RapidOne'-Cocaine-150 Test is a one-step lateral flow immunoassay for the qualitative detection of benzoyl ecgonine in human urine. 'RapidOne'-Cocaine-150 Test is intended for professional use. It is not intended for over the counter sales to nonprofessionals. The assay to perform, but should not be used without proper supervision. The immunoassay is a simplified, qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas chromatography/mass spectrometry (GC/MS). 'RapidOne'-Cocaine-150 Test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a more confirmed result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result. Particularly when preliminary results are used.

The assay employed in the 'RapidOne-Cocaine-150 Test is based on the same principle of highly specific reactions between antigens and antibodies. This assay is a one-step, competitive, immunoassay for the detection of benzoyl ecgonine in human urine. The test device consists of a membrane strip onto which a drug conjugate has been mobilized and a colloidal gold-antibody complex is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal goldantibody complex moves with the urine by capillary action to contact the immobilized drug conjugate. Antibody-antigen reactions occur, forming visible lines in the "test" area. When drug is present in the urine sample, the drug or metabolite will compete with the Drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled Antibody complex. If sufficient amount of drug is present, it will fill all of the available antibody binding sites, thus preventing attachment of the labeled antibody to the drug. conjugate. An absence of a color band (line) in the "test" area is indicative of a positive. A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence of absence of drug in the urine, and therefore, should be present on all reactions. A negative urine will produce two colored bands, and a positive sample will produce only one band.

The RapidTox™ is a one-step, lateral flow immunoassay for the simultaneous detection of up to ten abused drug analytes in urine (each analyte is represented by a line in the test window of the cassette). Rapid Tox is intended for use in the qualitative detection of the following drugs of abuse in human urine at the following levels: | Compound | Test<br>Abbreviation | Level (ng/ml) | |----------------------------------------------------------|----------------------|---------------| | Amphetamine (d-amphetamine sulfate) | AMP | 1000 | | Barbiturates (secobarbital) | BAR | 300 | | Benzodiazepine (oxazepam) | BZO | 300 | | Cocaine (benzoylecgonine) | COC | 300 | | MDMA ((+/-)3,4-methylenedioxy-methamphetamine) (Ecstasy) | MDMA | 1000 | | Methadone | MTD | 300 | | Methamphetamine ((+/-)methamphetamine HCl) | MET | 1000 | | Opiates (morphine-3-b-D-glucuronide) | OPI | 300 | | | | 2000 | | Oxycodone | OXY | 100 | | Phencyclidine (phencyclidine HCI) | PCP | 25* | | Propoxyphene/Norpropoxyphene | PPX | 300 | | THC/Cannabinoids (11-nor-A9-THC-9-carboxylic-acid) | THC | 50* | | Tricyclic Antidepressants (nortriptyline) | TCA | 1000 | Rapid Tox provides only a preliminary analytic test result. More specific alternative chemical methods must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. The Test is recommended for professional use. It is not intended for over-the-counter sales to nonprofessionals.

The RapidTox™ is a one-step, lateral flow immunoassay for the simultaneous detection of up to ten abused drug analytes in urine (each analyte is represented by a line in the test window of the cassette).

The Rapid Reader System is designed to read , capture, document and archive ABMC's Rapid Drug Screen®, Rapid One®, and Rapid TEC® screening immunoassays ("ABMC test"). The Rapid Reader is used to obtain qualitative results (equivalent to manual read test results) and is intended for professional and point of care use only. It is not intended for over the counter sale to non-professionals. This Reader, combined with ABMC tests is a simplified qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e., gaschromatography/mass spectrometry (GC/MS). The Rapid Reader System is a reader designed to capture, document and archive ABMC Drug of abuse test results using Rapid Drug Screen®, Rapid One®, and Rapid TEC® screening immunoassays ("ABMC tests"). The Rapid Reader is used to obtain qualitative results and is intended for professional use only. This Reader, combined with ABMC tests is a simplified qualitative screening method that provides a preliminary indication of drugs in urine. Results should be confirmed using appropriate confirmation methods. i.e., gas-chromatography/mass spectrometry (GC/MS).

The Rapid Reader utilizes a digital camera, pictures are analyzed using software algorithm developed to read any of American Bio Medica Corporation's (ABMC's) drugs of abuse screening immunoassays. These immunoassays include the Rapid Drug Screen®, Rapid One®, or Rapid TEC® drug of abuse test for the simultaneous detection of up to 10 drugs of abuse in human urine. All of these tests have been previously FDA cleared as Class II devices.

'Rapid One'-Propoxyphene Test is a one-step lateral flow immunoassay for the qualitative detection of 300 ng/ml of propoxyphene and norpropoxyphene in human urine. 'Rapid One'-Propoxyphene Test is intended for professional use. It is not intended for over-the-counter sales to nonprofessionals. The assay to perform, but should not be used without proper supervision. This immunoassay is a simplified, qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas chromatography/mass spectrometry (GC/MS.) 'Rapid One'-Propoxyphene Test provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a more confirmed result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result. Particularly when preliminary results are used.

The assay employed in the 'Rapid One'-Propoxyphene Test is based on the same principle of highly specific reactions between antigens and antibodies. This assay is a one-step, competitive, immunoassay for the detection of propoxyphene and its metabolite norpropoxyphene in human urine. The test device consists of a membrane strip onto which a drug conjugate has been immobilized and a colloidal goldmulti-antibody complex is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine by capillary action to contact the immobilized drug conjugates. Antibody-antigen reactions occur forming visible lines in the 'test' area. When drug is present in the urine sample, the drug or metabolite will compete with its corresponding drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex. If sufficient amount of drug is present, it will fill all of the available antibody binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color band (line) in the 'test' area is indicative of a positive result. A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence or absence of drug in the urine, and therefore, should be present on all reactions. A negative urine will produce two colored bands, and a positive sample will produce only one band.

'RapidTec'-5M-Multiple Drug Test is used for the qualitative detection of the following abused substances in human urine: methamphetamines, benzoyl ecgonine, phencyclidine, opiates and cannabinoids. This immunoassay is a simplified screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas chromatography/mass spectrometry (GC/MS.) 'RapidTec'-5M-Multiple Dip Test is a onc-step lateral flow immunoassay for the simultaneous qualitative detection of methamphetamines, benzoyl ecgonine, cannabinoids, phencyclidine, and opiates in urine.

The assays employed in the 'RapidTec'-5M-Multiple Dip Test is based on the same principle of highly specific reactions between antigens and antibodies. This assay is a one-step, competitive, immunoassay for the detection of marijuana, opiates, phencyclidine, cocaine and methamphetamine in human urine. The test device consists of a membrane strip onto which drug conjugates have been immobilized and a colloidal gold-multi-antibody complex dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine by capillary action to contact the immobilized drug conjugates. Antibody-antigen reactions occur forming visible lines in the 'test' area. When drug is present in the urine sample, the drug or metabolite will compete with its corresponding drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex. If sufficient amount of drug is present, it will fill all of the available antibody binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color band (line) in the 'test' area is indicative of a positive result. A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence or absence of drug in the urine, and therefore, should be present on all reactions. A negative urine will produce six colored bands, and a positive sample will produce only one band.

'RapidTec'-5 A-Multiple Dip Test is a one-step lateral flow immunoassay for the simultaneous qualitative detection of amphetamines, benzovl ecgonine, cannabinoids, phencyclidine, and opiates in urine. 'RapidTec' - 5 A-Multiple Dip Test is intended for professional use. It is not intended for over-the-counter sales to nonprofessionals. The assay is easy to perform, but should not be used without proper supervision. This immunoassay is a simplified, qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas chromatorgraphy/mass spectrometry (GC/MS.) 'Rapid Tec'-5A-Multiple Dip Test provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a more confirmed result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result. Particularly when preliminary results are used.

The assays employed in the 'RapidTec'-5A-Multiple Dip Test is based on the same principle of highly specific reactions between antigens and antibodies. This assay is a one-step. competitive, immunoassay for the detection of marijuana. opiates, phencyclidine, cocaine and amphetamine in human urine. The test device consists of a membrane strip onto which drug conjugates have been immobilized and a colloidal gold-multi-antibody complex dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine by capillary action to contact the immobilized drug conjugates. Antibody-antigen reactions occur forming visible lines in the 'test' area. When drug is present in the urine sample, the drug or metabolite will compete with its corresponding drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex. If sufficient amount of drug is present, it will fill all of the available antibody binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color band (line) in the 'test' area is indicative of a positive result. A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence or absence of drug in the urine, and therefore, should be present on all reactions. A negative urine will produce two colored bands, and a positive sample will produce only one band.