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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.

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 | |------------------|-----------------------------|-----------| | Phenobarbital | Phenobarbital | 200 ng/ml | | Tramadol | Tramadol | 200 ng/ml | | Phencyclidine | Phencyclidine | 25 ng/ml | | Buprenorphine | Norbuprenorphine | 5 ng/ml | | 6-Acetylmorphine | 6-Acetylmorphine | 10 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 immobilized 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 DOA Urine MultiPlex 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.

The Randox RX Daytona Plus Alkaline Phosphatase (ALP) test system is intended for the quantitative in vitro determination of Alkaline Phosphatase (ALP) activity in serum and lithium heparinized plasma. Measurements of alkaline phosphatase are used in the diagnosis, treatment and investigation of hepatobiliary disease and in bone disease.

The Randox RX Daytona Plus Alkaline Phosphatase (ALP) assay consists of ready to use reagent solutions.

For the quantitative in vitro determination of LDL-cholesterol concentration in human plasma and serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis and various liver and renal diseases. This in vitro diagnostic device is intended for prescription use only.

The LDL Cholesterol kit assay consists of ready to use reagent solutions. CATALOGUE NUMBER: CH8312 R1. Enzyme Reagent 1 4 x 20 mL R2. Enzyme Reagent 2 4 x 9 mL

The Direct Bilirubin test system is a device intended for the quantitative in vitro determination of Direct Bilirubin in serum and plasma. Bilirubin measurements can be used in the diagnosis and treatment of liver, hematological and metabolic disorders including hepatitis and gall bladder block. This device is for prescription use only.

The Randox Direct Bilirubin kit consists of ready to use reagent solutions. CATALOGUE NUMBER: BR8308 COMPONENTS: R1. 4 x 20ml, R2. 4 x 8ml REAGENT COMPOSITION R1. Direct Bilirubin RI Tartrate buffer, pH2.9 Detergent Antimicrobials and Preservatives Inhibitors Initial Concentration of Solutions 0.1 mol/L R2. Direct Bilirubin R2 Phosphate buffer, pH 7.0 Sodium Metavanadate Initial Concentration of Solutions 10 mmol/L 4 mmol/L

For the quantitative in vitro determination of Total Bilirubin for serum and plasma. Total Bilirubin measurements are used in the diagnosis and treatment of hemolytic, biliary and liver disorders, including hepatitis and cirrhosis. This in vitro diagnostic device is intended for prescription use only.

The Total Bilirubin kit assay consists of ready to use reagent solutions. CATALOGUE NUMBER: BR8307 R1. Total Bilirubin R1 4 x 20 mL R2. Total Bilirubin R2 4 x 8 mL REAGENT COMPOSITION Contents Initial Concentration of Solutions R1. Total Bilirubin R1 Citrate buffer, pH2.9 0.1 mol/L Detergent 0.9% Antimicrobial R2. Total Bilirubin R2 Phosphate buffer, pH 7.0 10 mmol/L Sodium Metavanadate 4 mmol/L MATERIALS REQUIRED BUT NOT PROVIDED Randox Assayed Multisera Level 2 (Cat. No. HN 1530) and Level 3 (Cat. No. HE 1532); 510(k) # k942458 Randox Calibration Serum Level 3 (Cat. No. CAL 2351); 510(k) # k053153 RX series Saline (Cat. No. SA 8396)

For the quantitative in vitro determination of Triglycerides in serum. Triglyceride measurements are used in the diagnosis and treatment of diseases involving lipid metabolism and various endocrine disorders e.g Diabetes mellitus, nephrosis and liver obstruction This in vitro diagnostic device is intended for prescription use only.

The Randox Triglycerides kit assay consists of ready to use reagent solutions.

The Liquid Assayed Chemistry Control Premium Plus Levels 1, 2 and 3 are assayed quality control materials intended for in vitro diagnostic use in the quality control of diagnostic assays. This material can be used to monitor the accuracy or reproducibility of analytes listed in the package insert. This device is for prescription use only.

The Liquid Assayed Chemistry Control Premium Plus is human liquid sera to which purified biochemical material, chemicals, drugs, preservatives and stabilizers have been added. The material is supplied at levels 1, 2 and 3. Each 5 ml vial of liquid serum is stored at -20°C to -70°C. Each level is supplied in a 12 by 5ml vials.

The Aldolase Calibration Serum is intended for in vitro diagnostic use in the calibration of Aldolase on the Randox RX Daytona and Beckman Coulter AU640 systems. This device is for prescription use only.

The Aldolase Calibrator is supplied in a kit containing 3x1ml vial of lyophilized serum is reconstituted with exactly 1 ml of distilled water and is stable for 5 days when reconstituted and stored at +2°C to +8° C. The base matrix used for the manufacture of the Aldolase Calibration Serum is Human Serum with added chemicals. Human source material from which this product has been derived and has been tested at the donor level for the Human Immunodeficiency Virus (HIV1 & HIV2) antibody, Hepatitis B surface antigen (HbsAg) and the Hepatitis C virus (HCV) antibody and were found to be non-reactive based on FDA approved methods. However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples should be handled as though capable of transmitting infectious diseases and disposed of accordingly.

This product is intended for in vitro diagnostic use as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert.

Randox Immunoassay Premium Plus Controls are manufactured at three levels, Level 1, Level 2 and Level 3. The materials are supplied as Level 1, Level 2 , Level 3 and a Tri-Level configuration. Each 5 ml vial of lyophilized serum is reconstituted with exactly 5 ml of distilled water at +20 to 25° C. The base matrix used for the manufacture of Randox Immunoassay Premium Plus Controls is Human Serum with added chemicals. Human source material from which this product has been derived and has been tested at the donor level for the Human Immunodeficiency Virus (HIV1 & HIV2) antibody, Hepatitis B surface antigen (HbsAg) and the Hepatitis C virus (HCV) antibody and were found to be non-reactive based on FDA approved methods. However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples should be handled as though capable of transmitting infectious diseases and disposed of accordinaly.