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Pan Probe Blotech (PPB), Inc. LiveSure™ Human Chorionic Gonadotropin (LiveSure™ hCG) Rapid Urinary Pregnancy Test Strip and Test Card Immunoassay Devices are in vitro diagnostic (IVD) qualitative screening lateral flow chromatographic immunoassays that are designed for rapid detection of placental hCG related to pregnancy at an expected value cut-off level of 20 mlU of hCG/ml of human urine. These LiveSure™ IVD immunoassay devices for urinary hCG pregnancy screening are neer non to give visual, qualitative results and are intended for professional use only. The PPB LiveSure™ hCG Test Strip and Test Card Devices are not intended for quantitative results, nor over-the-counter sales, but provide only professional use preliminary screening data for use to aid in the diagnosis of pregnancy. A clinical diagnosis by a medical professional must be obtained in order to confirm any analytical result, and to rule c: I any non-pregnancy diseases that can also result in elevated hCG. Clinical considerations and professional judgment should be applied to any test result, particularly when preliminary positive results are indicated.

The PPB LiveSure™ hCG Screen (i.e., LiveSure™ hCG) Test Strip and Test Card Devices are rapid qualitative lateral flow chromatographic IVD immunoassays and are intended for professional IVD use only. The Pan Probe Biotech LiveSure™ hCG Test Strip & Test Card Devices provide only preliminary analytical data for use to aid in the diagnosis of pregnancy. A clinical diagnosis by a medical professional must be obtained in order to confirm any analytical result. Each test device consists of a sample reaction unit, a pink colored colloidal gold conjugate unit pre-labeled with hGC-spec fic mouse-monoclonal antibody, and a chromatographic membrane was precoated with mouse-antialpha-hCG capture antibodies at the test band region and goat-antibody at the process control band region. During the test, the human urine specimen is allowed to react with hCG-specific mouse-monocloral antibodycolloid gold conjugate, which has been predried on the test component of each device. The mixture then moves chromatographically upward on the capillary action. For a pregnancy-positive specimen, gold conjugate complex binds to hCG at a level of 20 mlU/ml or greater, forming an antibody-antigen complex. This complex binds to hCG antibody as captured regents on the Test Region and produces a colored band when hCG concentration is equal to or greater than 20 mlU/ml. Absence of this colored band in the Test Region suggests a negative result Summarizing, negative urine will produce only one pink colored band in the control region, while positive urine will produce two pink colored bands, in both the control and test regions.

The Pan Probe Biotech (PPB), Inc LiveSure™ Methadone Screen Test Card & Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow competitive immuno-chromatographic urinary screening devices intended for detection of Methadone, its analogs and metabolites (collectively termed: screening at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Health Services Administration) cut-off level of 300 ng MED/ml of human urine. These PPB Mcharl Featur bervices Hand & Test Strip IVD immunoassay devices are designed for visual, qualitative screening, for professional use only, and are not intended for quantitative results, nor for quanuative berealling) for presentativeSure™ Methadone Test Card & Test Strip devices provide only ovel ate commal (or o) creening data for use to aid in the diagnosis of drug abuse or over use. A premium y quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA and SAMHSA have established gas chromatographic/mass spectrometry (GC/MS) as the result. NDTT and of micel considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The Pan Probe Biotech LiveSure™ Methadone Screen Test Card and Test Strip (i.e., LiveSure™ Methadone) which are rapid qualitative chromatographic IVD immunoassays, in which chemically labeled drug conjugate competes with any Methadone (MED) drugs, analogs or metabolites that may be in the conjugure comples for limited specific antibody binding sites. LiveSure™ Methadone devices prescient in test annual bas been pre-coated both with a Methadone (MED-)drug conjugate at the test band, and is followed by a built-in reference band with a second antibody as a system control band. A test colored anti-MED monoclonal antibody-colloidal gold conjugate pad is placed to the right of a test strip. In the absence of MED drugs, analogs or metabolites in urine, pink colored antibody-colloidal gold conjugates move chromatographically along with the urinary samples on the membrane by capillary ection. Antibody-colloidal gold conjugate binds to MED-drug conjugate, forming an antibody-antigen complex. This antibody-MED-drug conjugate appears as second visible pink colored band and captured reagent at the test region. Any MED present in a sample urine act as antigens, competing with MED-drug reagon at the test band region for limited MED-antibody binding sites on antibody-colloidal gold conjugate. When a sufficient concentration of urinary MED drugs, analogs or metabolites are present, these analytes block the limited antibody binding sites. This blockage-binding process prevents attachment of anial colored antibody-colloidal gold conjugate at the MED-drug conjugate zone located at the test band region. To serve as a procedural control, a pink colored band in a control region will always appear, regardless of the presence of MED in urine samples. Thus, negative urine samples produce two pink colored bands, while positive urine samples produce only one pink colored band.

The Pan Probe Biotech LiveSure™ Phencyclidine Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary rapid in Thiro didinestion of Phencyclidine, analogs and metabolites (collectively: PCP) in human urine at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Mental at the Nizes (national motified of 25 ng PCP/ml. These IVD tests are intended for visual, qualitative screening, for professional use only, and are not intended for quantitative visual, qualifative Screening, Tor prorocolonial ass "Chily" and PCP Screen Tests for PCP provide only preliminary qualitative analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA and SAMHSA have established gas chromatographic/mass spectrometry (GC/MS) as the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The Pan Probe Biotech LiveSure™ Phencyclidine Screen Test Card and Test Strip devices are rapid qualitative competitive chromatographic IVD immunoassays, in which a chemically labeled drug obligate competes for limited specific antibody binding sites. LiveSure™ PCP devices have a unique membrane pre-coated with a gold conjugate immunoassay indicator that is used is pre-labeled with specific monoclonal antibody from mouse directed against Indicator that is used to pro labora will opists of a membrane absorbent pad having a gold-probe-POr . Each rest othp and Toot ours control ontibody from mouse that is directed against PCP, Conjugate pre labolou with openits monecoated with a chemically modified PCP-conjugate as a and a chromatographio mombrare pro oats device has been layered with PCP-conjugate as a 11 capture reagent, while the Process Control region has been pre-coated with a first molledge and capture Teagent derived from goat. A pink colored anti-PCP monoclonal antibody-colloidal gold anabody reagent derivou from goal. A phe test strip. In the absence of PCP drug, analogs or conjugate paa is placed to sample, the pink colored antibody-colloidal gold conjugate moves chromatographically along with the urinary sample on the membrane by capillary action. Antibodycolloidal gold conjugate binds to PCP-drug conjugate, forming an antibody-antigen complex. This collondar gold conjugate appears as second visible pink colored band and captured reagent at the test region. Any PCP drug, analogs or metabolites that are present in sample urine act as the test region. Any PCP-drug conjugate at the test band region for limited PCP-antibody amigone, oomponing min-reloidal gold conjugate. When a sufficient concentration of urinary PCP blog, analogs or metabolites are present, these analytes block the limited antibody binding sites. This andy, and oge of measons of pink colored antibody-colloidal gold conjugate to the PCPblookugo binding provents d at the test band region. To serve as a procedural control, a pink colored arag control region will always appear regardless of the presence of PCP in urinary samples. band in a ountrol rogion will amays appear of an and while positive urine samples produce only one pink colored band.

The Pan Probe Biotech LiveSure™ Benzodiazepines Screen Test Card and Test Strip devices are qualitative lateral flow immuno-chromatographic competitive urinary rapid in vitro diagnostic (IVD) qualitative assays for detection of Benzodiazepines drugs, and metabolites (BZD) in human urine at the NIDA (National Institute of Drug Abuse) cut-off of 300 ng BZD/ml. The cut-off for both LiveSure™ Test Card and Test Strip device methods has been set at 300 ng BZD drug/ml based upon calibration using the parent benzodiazepine/BZD drug, and using Oxazepam standards with a GC/MS method for the quantitation of all the Oxazepam standard and urine test solutions. These IVD tests are intended for visual, qualitative screening, for professional use only, and are not intended for quantitative results, nor for over the counter sales. Pan Probe Biotech LiveSure™ BZD Screen Tests for BZD provide only preliminary qualitative analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA recommends gas chromatography/mass spectrometry (GC/MS) as the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The Pan Probe Biotech LiveSure™ Benzodiazepines Screen Test Card and Test Strip (i.e., LiveSure™ BZD Screen Tests) devices are rapid qualitative competitive chromatographic IVD immunoassays, in which a chemically labeled drug conjugate competes with any Benzodiazepine (BZD) drugs, analogs or metabolites that may be present in test urine samples for limited specific antibody binding sites. LiveSure™ Benzodiazepines devices have a unique membrane pre-coated with a gold conjugate immunoassay indicator that is pre-labeled with specific monoclonal antibody from mouse directed against BZD drugs. The Test Strip and Test Card consists of a membrane absorbent pad having a gold-probe-conjugate pre-labeled with specific monoclonal antibody from mouse that is directed against BZD drugs, and a chromatographic membrane pre-coated with a chemically modified Benzodiazepine (Oxazepam) drug-conjugate as a capture reagent. The Test region of each device has been layered with a Benzodiazepine [Oxazepam] drug-conjugate as a 1st capture reagent, while the Process Control region has been pre-coated with a 2nd anti-mouse antibody reagent derived from goat. A pink colored anti-BZD monoconal antibody-colloidal gold conjugate pad is placed to the right of a test strip. In the absence of BZD drugs, analogs or metabolites in urine, pink colored antibody-colloidal gold conjugates move chromatographically along with the urinary samples on the membrane by capillary action. Antibody-colloidal gold conjugate binds to BZD-drug conjugate, forming an antibody-antigen complex. This antibody-BZD-drug conjugate appears as second visible pink colored band and captured reagent at the test region. Any BZD drugs, analogs or metabolites that are present in a sample urine act as antigens, competing with BZD-drug conjugate at the test band region for limited BZD-antibody binding sites on antibody-colloidal gold conjugate. When a sufficient concentration of urinary BZD drugs, analogs or metabolites are present, these analytes block the limited antibody binding sites. This blockage-binding prevents attachment of pink colored antibody-colloidal gold conjugate at the BZD-drug conjugate zone located at the test band region. To serve as a procedural control, a pink colored band in a control region will always appear, regardless of the presence of BZD in urine samples. Thus, negative urine samples produces two pink colored bands, while positive urine samples produce only one pink colored band.

The Pan Probe Biotech LiveSure™ Barbiturates Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary assays for the detection of Barbiturates (e.g., Amobarbital, Butalbital, Pentobarbital, Secobarbital, Phenobarbital, Phenobarbital, etc.), analogs and metabolites (collectively termed: BAR) in human urine at the NIDA (National Institute on Drug Abuse) modified (Substance Abuse and Mental Health Services Administration) cut-off level of 300 ng BAR/M. The cut-off for both LiveSure™ Test Card and Test Strip device methods has been set at 300 ng BAR drug/ml based upon calibration using Secobarbital as a prototype Barbiturate/BAR drug, and ng BRK drugmit bagod upen vith a GCMS method for the quantitation of all the Secobarbital standard and urine test solutions. These IVD Tests are intended for visual, qualitative screening, for professional use only, and are not intended for quantitative results, nor for over the counter sales. Pan Probe Biotech LiveSure™ BAR Screen Tests for BAR provide only preliminary analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. Both NIDA and SAMHSA have established gas chromatography/mass spectrometry (GC/MS) as a preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The Pan Probe Biotech LiveSure™ Barbiturates Screen Test Card and Test Strips (i.e., LiveSure™ Barbiturates) devices are rapid qualitative competitive chromatographic IVD immunoassays, in which chemically labeled drug conjugate competes with any Barbiturate (BAR) drugs, analogs or metabolites that may be present in test urinary samples for limited specific antibody binding sites. LiveSure™ Barbiturates devices have a unique membrane pre-coated with a gold conjugate immunoassay indicator that is used is pre-labeled with specific monoclonal antibody from mouse directed against BAR. Each Test Strip and Test Card consists of a membrane absorbent pad having a gold-probe-conjugate pre-labeled with specific monoclonal antibody from mouse that is directed against BAR, and a chromatographic membrane precoated with a chemically modified Barbiturate [Secobarbital] drug-conjugate as a capture reagent. The Test region of each device has been layered with a Barbiturate [Secobarbital] drug-conjugate as a 1" capture region of dail the Process Control region has been pre-coated with a 200 anti-mouse antibody reagent derived from goat. A pink colored antibody-colloidal gold conjugate pad is placed to the right of a test strip. In the absence of BAR drugs, analogs or metabolites in urine, pink colored antibodycolloidal gold conjugates move chromatographically along with a urinary sample on the membrane by capillary action. Antibody-colloidal gold conjugate binds to BAR-drug conjugate, forming an antibodyantigen complex. This antibody-BAR-drug conjugate appears as a second visible pink colored band and as a captured reagent at the test region. Any BAR drugs, analogs or metabolites that are present in a sample urine act as antigens, competing with BAR-drug conjugate at the test band region for limited BAR-antibody binding sites on antibody-colloidal gold conjugate. When a sufficient concentration of urinary BAR drugs, analogs or metabolites are present, these analytes block the limited antibody binding sites. This blockagebinding prevents attachment of pink colored antibody-colloidal gold conjugate at the BAR-drug conjugate zone located at the test band region. To serve as a procedural control, a pink colored band in a control region will always appear, regardless of presence of BAR in urine samples. Thus, negative urine samples produces two pink colored bands, while positive urine samples only one pink colored band.

The Pan Probe Biotech LiveSure™ Amphetamine Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic urinary assays for detection of D-Amphetamine (AMP) in human urine at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Mental Health Services Administration) cut-off level of 1000 ng AMP/ml. These tests are intended for visual, qualitative IVD screening, and professional use only, and are not intended for quantitative results, nor for over the counter use. These screen tests for Amphetamine, analogs and metabolites provide only preliminary qualitative analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA and SAMHSA recommend gas chromatography/mass spectrometry (GCMS) as the preferred confirmed analytical method. Clinical Considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The Pan Probe Biotech LiveSure™ Amphetamine Screen Test Card and Test Strip (i.e., LiveSure™ Amphetamine Tests) are rapid qualitative chromatographic immunoassays in which a chemically labeled drug conjugate competes with Amphetamine (AMP) drug, analogs or metabolites that may be present in test urinary samples for limited specific antibody binding sites. LiveSure™ Amphetamine devices contain a unique membrane that has been pre-coated both with AMP drug conjugate at the test band, and have a built-in reference band with second antibody as a system control band. A pink colored anti-AMP monoclonal antibody-colloidal gold conjugate pad is placed on the test strip. In the absence of AMP drug, analogs or metabolites in the test urine, the pink colored antibody-colloidal gold conjugate moves chromatographically along with the urinary sample on the capillary action. The antibody-colloidal gold conjugate binds to drug conjugate, forming an antibody-antigen complex. This complex binds to drug conjugate as a captured reagent at the test region and produces a visible pink colored band. When AMP is present in a test urine, that drug, analog or metabolite antigen competes with AMP conjugate at the test band region for the limited antibody sites on the antibody-colloidal gold conjugate. When a sufficient concentration of urinary AMP drug, analogs or metabolites is present, it blocks limited antibody binding sites. This blockage-binding prevents attachment of pink colored antibody-colloidal gold conjugate to the Amphetamine drug conjugate zone located at the LiveSure™ Amphetamine test band region. To serve as a procedural control, a pink colored band in a control region will always appear regardless of presence of AMP in samples. Thus, negative urine samples produces two pink colored bands, while positive urine samples produce only one pink colored band.

The Pan Probe Biotech LiveSure™ Methamphetamine Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary assays for the detection of Methamphetamine (MET) and its analogs or metabolites in human urine at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Mental Health Services Administration) cut-off level of 1,000 ng MET/ml. These tests are intended for visual, qualitative IVD screening, for professional use only, and are not intended for quantitative results, nor for over the counter sales. These screen tests for Methamphetamine, provide only preliminary qualitative analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA and SAMHSA have established gas chromatographic/mass spectrometry (GC/MS) as the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The Pan Probe Biotech LiveSure™ Methamphetamine Screen Test and Test Strip (i.e., LiveSure™ Methamphetamine) are rapid qualitative competitive chromatographic immunoassays in which a chemically labeled drug conjugate competes with Methamphetamine drug, analogs or metabolites that may be present in test urinary samples for limited specific antibody binding sites. LiveSure™ Methamphetamine devices contain a unique membrane that has been pre-coated both with Methamphetamine drug conjugate at the test band, and have a builtin reference band with second antibody as a system control band. A pink colored anti-Methamphetamine monoclonal antibody-colloidal gold conjugate pad is placed on the right side of the test strip. In the absence of Methamphetamine drug, analogs or metabolites in the pink colored antibody-colloidal gold conjugate moves chromatographically along with the urinary sample on the capillary action. The antibodycolloidal gold conjugate binds to drug conjugate, forming an antibody-antigen complex binds to drug conjugate as a captured reagent at the test region and produces a visible pink colored band. When Methamphetamine is present in a test urine, that drug, analog or metabolite antigen competes with Methamphetamine conjugate at the test band region for the limited antibody sites on the antibody-colloidal gold conjugate. When a sufficient concentration of unnary Methamphetamine drug is present, it blocks limited antibody binding sites. This blockage-binding prevents attachment of pink colored antibody-colloidal gold conjugate to the Methamphetamine drug conjugate zone located at the LiveSure™ Methamphetamine test band region. To serve as a procedural control, a pink colored band in a control region will always appear regardless of presence of Methamphetamine in samples. Thus, negative unne samples produces two pink colored bands, while positive urine samples produce only one pink colored band.