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New FDA-Cleared Oral Fluid Testing Kits Join Thermo Fisher Scientific Reagents and Quest Diagnostics Oral-Eze Patented Collection Technology

26 Jul 2011
bridget bridget
Laboratory Director

Product news

Thermo Fisher Scientific Inc. today announced U.S. Food and Drug Administration clearance and launch of six new Thermo Scientific Oral Fluid Drugs of Abuse immunoassays that test for amphetamines, cannabinoids (THC), cocaine, methamphetamines, opiates, and PCP.

The Thermo Scientific reagents complement the patented Oral-Eze oral fluid specimen collection device from Quest Diagnostics. The immunoassays and specimen collection device are available for in vitro diagnostics use. The company will showcase the products at Thermo Scientific booth #1720 during Clinical Lab Expo at AACC 2011, being held July 26 – July 28, at the Georgia World Congress Center, Atlanta, Georgia.

Oral fluid tests (OFT) for drugs of abuse offer a valuable alternative to traditional urine sample testing. Collection is observed and non-invasive, reducing the risk of adulterated samples. Samples can be collected during routine field visits or regular check-ins, eliminating the need for laboratory collection. These qualitative tests are used as screening tools to aid in the investigation of drug use. As with any drug screening, confirmation testing is required.

Accompanying the immunoassays are Oral Fluid Calibrators and control sets. Analyte-specific calibrators and control sets are available for the Cannabinoids OFT and the Methamphetamine OFT kits, while Multi-Drug OFT Calibrators and Multi-Drug Control Set support amphetamine, cocaine, opiate, and PCP oral fluid immunoassays.

While they use the same, proven cloned enzyme donor immunoassay technology as urine drug monitoring products, these new oral fluids assays, calibrators and control sets introduce new options in drug screening. Kits are available in a range of sizes to meet specific test volume needs. Calibrators are liquid, ready-to-use and offer three-point calibration: negative, cut-off and high. The Oral Fluid Control Set is packaged with low and high control at ± 50 percent of cut-off and can be used with any reagent lot. Oral fluid screening is now faster and more cost-effective using the clinical chemistry analyzers, such as the MGC 240 bench top analyzer or other chemistry analyzers for larger test volumes. Applications on a variety of chemistry analyzers are also available.

For more information about Thermo Scientific reagents, please visit booth #1720 during AACC 2011 or visit the company article page.

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Combinatorial ChemistryCombinatorial chemistry, also known as combichem, is a technique used in drug discovery to create libraries of structurally related compounds. A library is generated by synthesis with a chemical reactor system or by computer-based modeling of compound combinations. When undertaking combinatorial chemistry consider reagents, buffers, resins and standards.High-Throughput ScreeningHigh-throughput screening (HTS) is an automated drug discovery technique for identification of active compounds against a compound library. Use HTS readers and integrated assay preparation / analysis workstations to screen your compounds. Identify active compounds against various HTS libraries, including membranes, proteins and peptides and HTS cell lines. Find the best high-throughput screening products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.ADME-ToxicologyADME-toxicology (ADME-Tox) studies are used in pharmacology and pharmacokinetics to assess the activity/toxicity of drugs <i>in vivo</i> or <i>in vitro</i>. Find bioassays for absorption, distribution, metabolism, and excretion of drug molecules including cytotoxicity, transporter/permeability, metabolism and activity assays as well as hepatocytes and cell lines for ADME. Find the best ADME-toxicology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Assay AssemblyAssay Assembly is technique used in drug discovery to develop assays to test the cytotoxicity, genotoxicity, or other activities of a compound on a cell. Assay assembly requires chip assembly, a delivery system and a detection and analysis method. Beneficial features of assay kits or automated systems include high-throughput, high speed and sensitivity and low signal to noise ratio.Medicinal ChemistryMedicinal chemistry is a broad discipline encompassing the design, identification, synthesis and development of chemicals in drug discovery. It includes a number of techniques covering structural biology, synthetic chemistry and molecular biology. Technologies used in medicinal chemistry include ADME, lab-on-a-chip, high content screening and assay assembly.Process ChemistryProcess chemistry is an important stage of drug development for scaling-up drug production or chemical synthesis reactions. It is useful for optimizing economical and efficient drug production. Process chemistry uses reactors and pump systems as well as reagents, standards and buffers.HematologyIn Haematology / Hematology, complete blood cell counts (or full blood counts) are obtained using automated blood count analyzers to enumerate blood cell types.  Hematology also encompasses haemostasis and coagulation, thrombophilia and hemophilia, plasma viscosity and ESR analysis, hemoglobinopathies, cell morphology and haematinic measurement.ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.High-Content ScreeningHigh-content screening (HCS), also known as high-content analysis (HCA), is a high-throughput technique used in drug discovery to identify substances that alter the phenotype of cells. HCS uses fluorescent microscopic imaging and automated image analysis to investigate cellular events such as apoptosis, cell viability, GPCR activation, oxide production, neurite outgrowth, and cell signaling. Find the best fluorescent labeling reagents, cellular assays, and high-content imaging systems in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Point-of-CarePoint-of-Care Testing (POCT) or Near Patient Testing (NPT) products are available for urine, blood and other clinical chemistry analyses. POCT includes: blood glucose testing, blood gas and electrolytes analysis, rapid coagulation testing (PT / INR), rapid cardiac markers diagnostics, drugs of abuse screening, urine strips testing, pregnancy testing, fecal occult blood analysis, food pathogens screening, hemoglobin diagnostics, infectious disease testing and cholesterol screening.Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.Clinical TrialsClinical Trials, an essential part of drug discovery process, assess the safety and effectiveness of a new medication or device in the pharmaceutical industry. Clinical Trials are a phased process (Phase 0, Phase I, Phase II, Phase III and Phase IV) which begins after initial preclinical testing.Clinical GeneticsMolecular Genetics covers the analysis of hereditary genetic disease and chromosomal abnormalities. Genetics can be analysed using DNA, RNA, and protein microarrays, PCR, RT PCR and DNA sequencing. Genetic equipment includes genetic workstations, thermal cyclers, cooling blocks and electrophoresis products. Diagnostic kits are used for DNA / RNA extraction and purification.

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New FDA-Cleared Oral Fluid Testing Kits Join Thermo Fisher Scientific Reagents and Quest Diagnostics Oral-Eze Patented Collection Technology