Search Results

The LZI Fentanyl III Enzyme Immunoassay is intended for the qualitative determination of fentanyl in human urine at the cutoff value of 1 ng/mL when calibrated against fentanyl. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

The LZI Fentanyl III Enzyme Immunoassay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. The assay is based on competition between the drug in the sample and the drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. The drug-labeled G6PDH conjugate is traceable to a commercially available fentanyl standard and referred to as fentanyl-labeled G6PDH conjugate. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of a drug in the sample, fentanyl-labeled G6PDH conjugate is bound to the antibody, and the enzyme activity is inhibited. On the other hand, when the free drug is present in the sample, the antibody would bind to the free drug; the unbound fentanyl-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm. The LZI Fentanyl III Enzyme Immunoassay is a kit comprised of two reagents, R1 and R2, which are bottled separately but sold together within the kit. The R1 solution contains mouse monoclonal anti-fentanyl antibody, glucose-6-phosphate (G6P), nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with fentanyl in buffer with sodium azide (0.09%) as a preservative.

BioSieve™ Fentanyl FIA Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ ToxiSmart FIA Reader. It is for in vitro diagnostic use only. It is intended for prescription use. The tests provide only preliminary results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the preliminary test result is positive. BioSieve™ ToxiSmart FIA Reader is a portable fluorescence instrument for in vitro diagnostic use only. The Reader is designed to perform in vitro diagnostic tests on urine specimens. This Reader can be used in a laboratory or in a point-of-care setting.

This test uses a lateral flow design with location-dependent lines and zones. BioSieve™ ToxiSmart FIA Reader scans the test strip and displays results. The sample is added to the sample well of the test card, and the sample is drawn by capillary action into and through the fluorescent labeled pad, through the nitrocellulose strip and into the adsorption pad. Within the fluorescent labeled pad, the specimen comes into contact with antibodies conjugated with fluorescent microspheres. During this interaction, if the amount of fentanyl antigen in the sample is greater than or equal to the cutoff value, the antigen in the sample and the fluorescence-labeled antibody bind to the FTY antigenantibody complex when the sample passes through a pad of fluorescence-microbead-labeled antibody conjugate. As the sample flows and reaches the FTY antigen coated by the T-line of nitrocellulose membrane, the FTY antigen coated by the T-line antigen in the sample competitively bind the FTY antibody labeled with fluorescence, then the T-line captures fluorescence signal is weaker than the cutoff fluorescence signal. When the samples do not contain fentanyl antigen or levels below the cutoff value, as the sample flow, fluorescent microsphere labeled antibody to nitrocellulose membrane T line captures fluorescent signal is stronger than the cutoff fluorescence signal. Whether or not FTY antigen was present in the sample, the rabbit IgG fluorescent microsphere conjugate not bound to the test line continued to flow with the rest of the sample and soon encountered a control line composed of goatanti-rabbit IgG. The position of C-line will accumulate fluorescence signal. The C-line control area was scanned to confirm that adequate sample flow had occurred. High resolution, narrow band SMD LED was used as light source in the Immunofluorescence Analyzer. The central wavelength of the excitation spectrum is 365nm. The central response wavelength is 610nm.

Dochek® Multi-Drug Urine Test Dipcard Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations: Amphetamine (AMP) 1000 or 500 ng/mL Secobarbital (BAR) 300 ng/mL Buprenorphine (BUP) 10 ng/mL Oxazepam (BZO) 300 ng/mL Cocaine (COC) 300 or 150 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL Methylenedioxymethamphetamine (MDMA) 500 ng/mL Methamphetamine (MET) 1000 or 500 ng/mL Morphine (MOP/OPI) 300 or 2000 ng/mL Methadone (MTD) 300 ng/mL Oxycodone (OXY) 100 ng/mL Phencyclidine (PCP) 25 ng/mL Propoxyphene (PPX) 300 ng/mL Nortriptyline (TCA) 1000 ng/mL Cannabinoids (THC) 50 ng/mL 6-Monoacetylmorphine (6-MAM) 10 ng/mL Dochek® Multi-Drug Urine Test Dipcard Rx offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device. It is intended for prescription use. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS is the recommended confirmatory method. Dochek® Multi-Drug Urine Test Dipcard is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations: Amphetamine (AMP) 1000 or 500 ng/mL Secobarbital (BAR) 300 ng/mL Buprenorphine (BUP) 10 ng/mL Oxazepam (BZO) 300 ng/mL Cocaine (COC) 300 or 150 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL Methylenedioxymethamphetamine (MDMA) 500 ng/mL Methamphetamine (MET) 1000 or 500 ng/mL Morphine (MOP/OPI) 300 or 2000 ng/mL Methadone (MTD) 300 ng/mL Oxycodone (OXY) 100 ng/mL Phencyclidine (PCP) 25 ng/mL Propoxyphene (PPX) 300 ng/mL Nortriptyline (TCA) 1000 ng/mL Cannabinoids (THC) 50 ng/mL 6-Monoacetylmorphine (6-MAM) 10 ng/mL Dochek® Multi-Drug Urine Test Dipcard offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.

Dochek® Multi-Drug Urine Test Dipcard Rx and Dochek® Multi-Drug Urine Test Dipcard are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine at or above the cut-off levels as indicated. The products are singleuse in vitro diagnostic devices. This device is a dipcard format in which the test strips are integrated into the plastic dipcard. After removing the cap of the dipcard, the absorbent end of the test strips is exposed and can be in direct contact with the urine sample. The device is in a ready-to-use format and no longer requires assembly before use.

The Rapid Fentanyl (FYL) Test Strip is a rapid, screening test for the qualitative detection of Fentanyl (FYL) in human urine at the cut-off concentration of 1 ng/mL. The tests is intended for in vitro diagnostics use. It is intended for prescription use including point of care sites. This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. Gas Chromatography/ Mass spectrometry (GC/MS) or Liquid chromatography/Mass spectrometry (LC/MS) is 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. The Rapid Fentanyl (FYL) Test Dipcard is a rapid, screening test for the qualitative detection of Fentanyl (FYL) in human urine at the cut-off concentration of 1 ng/mL. The tests is intended for in vitro diagnostics use. It is intended for prescription use including point of care sites. This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. Gas Chromatography/ Mass spectrometry (GC/MS) or Liquid chromatography/Mass spectrometry (LC/MS) is 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.

Rapid Fentanyl (FYL) Test Strip and Rapid Fentanyl (FYL) Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of fentanyl at or above the cut-off concentration of 1 ng/mL. The tests can be performed without the use of an instrument. Test Strip and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures.

Accurature Multi-drug Urine Test Cup and Accurature Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of: | Drug | Abbreviation | Cut-off | |--------------------------------|--------------|-----------| | Amphetamine | AMP | 1000ng/mL | | Secobarbital | BAR | 300 ng/mL | | Buprenorphine | BUP | 10 ng/mL | | Opzaepam | BZO | 300 ng/mL | | Cocaine | COC | 300 ng/mL | | Methylenedioxy-methamphetamine | MDMA | 500 ng/mL | | Methamphetamine | MET | 1000ng/mL | | Morphine | MOR | 300 ng/mL | | Methadone | MTD | 300 ng/mL | | Oxycodone | OXY | 100 ng/mL | | Phencyclidine | PCP | 25 ng/mL | | Marijuana | THC | 50 ng/mL | Configuration of the Accurature Multi-drug Urine Test Cup and Accurature Multi-drug UrineTest Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam Secobarbital and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. For over-the-counter use. Multi-drug Urine Test Cup and Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of: | Drug | Abbreviation | Cut-off | |--------------------------------|--------------|-----------| | Amphetamine | AMP | 1000ng/mL | | Secobarbital | BAR | 300 ng/mL | | Buprenorphine | BUP | 10 ng/mL | | Opzaepam | BZO | 300 ng/mL | | Cocaine | COC | 300 ng/mL | | Methylenedioxy-methamphetamine | MDMA | 500 ng/mL | | Methamphetamine | MET | 1000ng/mL | | Morphine | MOR | 300 ng/mL | | Methadone | MTD | 300 ng/mL | | Oxycodone | OXY | 100 ng/mL | | Phencyclidine | PCP | 25 ng/mL | | Marijuana | THC | 50 ng/mL | Configuration of the Multi-drug Urine Test Cup and Multi-drug Test Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam Secobarbital and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. For prescription use only.

The subject device will be sold in two formats: Multi-drug Urine Test Dip Card and Multi-drug Urine Test Cup. Multi-Drug Urine Test Cup and Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Marijuana, Cocaine, Methamphetamine, Morphine, Oxazepam, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone in human urine samples. Multi-Drug Urine Test devices detect each of analytes on different strips. A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Amphetamine, Marijuana, Cocaine, Methamphetamine, Morphine, Oxazepam, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.

The LYHER® Urine Multi-Drug Test Kit (Cup), LYHER® Urine Multi- Drug Test Kit (Cassette), and LYHER® Urine Multi-Drug Test Kit (Dipcard) are rapid lateral flow immunoassays for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: | Test | Calibrator | Cut-off (ng/mL) | |-----------------------|----------------------|-----------------| | Amphetamine (AMP) | d-Amphetamine | 1000 | | Cocaine (COC) | Benzoylecgonine | 300 | | Marijuana (THC) | 11-nor-Δ9-THC-9-COOH | 50 | | Methamphetamine (MET) | d-Methamphetamine | 1000 | | Opiates(OPI) | Morphine | 2000 | | Phencyclidine (PCP) | Phencyclidine | 25 | The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 6 analytes. 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 result. 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.

The LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The LYHER® Urine Multi-Drug Test Kit (Cup) device consists of 25 or 40 cup devices and a package insert. The LYHER® Urine Multi-Drug Test Kit (Dipcard) device consists of 10/15/20/25 Dip Card devices, a package insert. The LYHER® Urine Multi-Drug Test Kit (Cassette) device consists of 10/15/20/25 cassette devices, 10/15/20/25 droppers, a package insert.

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.

Dochek® Multi-Drug Urine Test Cup Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table. Dochek® Multi-Drug Urine Test Cup Rx offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device . It is intended for prescription use. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result,particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method. Dochek® Multi-Drug Urine Test Cup is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table. Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device . It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result,particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.

Dochek® Multi-Drug Urine Test Cup Rx and Dochek® Multi-Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The device is a cup format. The test strips are integrated into the cup provided and the urine sample is collected directly into the cup containing the strips. Each cup device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

The ARK Hydrocodone Assay is an immunoassay intended for the qualitative detection and/or semi-quantitative estimation of hydrocodone and its metabolites in human urine at a cutoff of 300 ng/mL. The semi-quantitative mode is for the purpose of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method, such as Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS), or (2) permitting laboratories to establish quality control procedures. The ARK Hydrocodone Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed positive analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the preliminary test result is positive.

The ARK Hydrocodone Assay is supplied as a liquid ready-to-use homogeneous enzyme immunoassay. The assay is based on competition between hydrocodone in the specimen and hydrocodone labeled with recombinant glucose-o-phosphate dehydrogenase (rG6PDH) for antibody binding sites. As the latter binds antibody, enzyme activity decreases. In the presence of hydrocodone from the specimen, enzyme activity increases and is directly related to the hydrocodone concentration. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically. Endogenous G6PDH does not interfere because the coenzyme NAD functions only with the bacterial enzyme used in the assay. The ARK Hydrocodone Assay consists of reagents R1 anti-hydrocodone monoclonal rabbit antibodies with substrate and R2 hydrocodone derivative labeled with bacterial recombinant G6PDH enzyme.

The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cutoffs. The Evidence MultiSTAT DOA Urine MultiPlex detects the following drugs at the following cut-offs: | Analyte | Analyte in Cut Off Material | Cut-Off | |-------------------|-----------------------------|-----------| | Benzodiazepines I | Oxazepam | 200 ng/mL | | Methamphetamine | S-(+)-Methamphetamine | 500 ng/mL | | Noroxycodone | Noroxycodone | 100 ng/mL | | Methadone | (±)-Methadone | 300 ng/mL | The Evidence MultiSTAT DOA Urine MultiPlex provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and/or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) are the preferred confirmatory methods. Other chemical confirmation methods are available. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. For in vitro diagnostic use only.

The Evidence MultiSTAT analyzer is a benchtop fully automated Biochip Array System. It performs simultaneous detection of multiple analytes from a single sample. The core technology is the Randox Biochip, a solid-state device containing an array of discrete test regions containing immobilised antibodies specific to different Drugs of Abuse (DOA) compound classes, A competitive chemiluminescent immunoassay is used for the DOA assays with the drug in the specimen and drug labelled with horseradish peroxidase (HRP) being in direct competition for the antibody binding sites. Increased levels of drug in a specimen will lead to reduced binding of drug labelled with HRP and thus a reduction in chemiluminescence being emitted. The light signal generated from each of the test regions on the biochip is detected by a Charge Coupled Device (CCD) camera in the Evidence MultiSTAT system which, together with the analyzer software, is used to quantify the light output and produce meaningful results. The immunoassay processes are performed automatically in a self-contained and sealed biochip cartridge, which holds the biochips, the reagents, wash buffer and other fluids required for the test to be conducted. Evidence MultiSTAT assays employ a qualitative reporting method. Each test sample is assayed against the provided Cut Off material of known concentration, which is used to determine the classification of the samples based on the comparison of the signal output. The Evidence MultiSTAT System uses Randox Biochip Technology and performs simultaneous detection of multiple analytes from a single sample, using the Evidence MultiSTAT Analyzer. The assays are diagnostic tests for qualitative determination of the parent molecule and metabolites of drugs in human urine. The qualitative tests are based on a cut off value for each analyte, as detailed in the table below.