Feature Channels: Addiction

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Beckman Coulter’s Prostate Health Index (phi)* has been recommended by the National Comprehensive Cancer Network (NCCN) as a blood test to improve specificity for prostate cancer detection in its recently updated Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Prostate Cancer Early Detection. Inclusion in the NCCN Guidelines recognizes the benefit and clinical utility of phi for better prostate cancer diagnosis and for the reduction of unnecessary biopsies.

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Beckman Coulter Diagnostics, a global leader in prostate cancer diagnostics, announces national availability of the Prostate Health Index (phi)*, a simple, non‐invasive blood test that is three times more specific in detecting prostate cancer1 than PSA (prostate‐specific antigen). The new test’s accuracy decreases the need for many men who test positive for elevated PSA levels to undergo a biopsy in order to achieve a reliable diagnosis.

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hc1.com®, the Healthcare Relationship CloudTM company, and Beckman Coulter Diagnostics, a global leader in developing clinical diagnostic products that help advance and optimize the laboratory, announced a strategic partnership to deliver innovative technology to laboratories that turn large amounts of clinical data into actionable insights that transform how labs manage their business and their contributions to improving healthcare.

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EKF Diagnostics, the global diagnostics company, will be highlighting its expanding product portfolio on its subsidiary Stanbio Laboratory’s booth #1933 at the AACC Clinical Lab Expo in Chicago, USA, July 29-31. In addition to demonstrating success of current products, including Stanbio’s ß-HB assay technology and EKF Molecular’s Pointman technology, new products will be introduced at AACC. These latest introductions are a result of EKF’s recent acquisition of Separation Technology Inc. (STI) and DiaSpect Medical.

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EKF Diagnostics, the global diagnostics company, announces that the latest results from its collaboration with the Institute of Life Sciences at the University of Swansea, UK, have continued to confirm the effectiveness of its PointMan™ DNA enrichment technology for isolating and characterizing low-level DNA mutations in blood. This is significant since with such sensitivity, it paves the way for the possibility of using a simple blood test to screen and diagnose different cancers, as well as monitor the efficacy of anti-cancer therapies.

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ALCOR Scientific announced it has expanded availability of its iSED® system for erythrocyte sedimentation rate (ESR) testing to new markets to meet growing demand for this advanced technology.

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SelectScience will be announcing the winner of the Scientists’ Choice Award for Best New Clinical Laboratory Product of 2013, at booth #4676, on Wednesday 30th July. The award will be presented by Sonia Nicholas, Clinical Diagnostics Editor for SelectScience.

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Streck has more than 2,600 ESR-Auto Plus® instrument placements worldwide. The ESR-Auto Plus accurately and precisely measures the sedimentation rate of erythrocytes; several key features provide improved laboratory efficiency for technologists.

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COLA, the largest private accreditor of medical laboratories serving more than 8,000 across the U.S., successfully concluded its 2014 Leadership Summit in April. More than 30 thought leaders in health care, including physicians, regulators, public health experts, medical laboratory scientists, manufacturers, nurse practitioners and more gathered in San Francisco to discuss the future of laboratory medicine in the context of the Affordable Care Act (ACA). The group explored the implications of the dynamics of ACA and changing payment policies on quality and learning in laboratory medicine.

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The nation’s healthcare system -- and with it, the laboratory community – is undergoing a period of tremendous change as The Affordable Care Act begins implementation and new healthcare delivery models such as The Patient-Centered Medical Home (PCMH) and Accountable Care Organizations (ACOs) proliferate. With more than 70 percent of medical decisions based on lab data, laboratories are emerging as vital partners of these new healthcare teams. Labs are uniquely qualified to use the patient data they capture to provide feedback to allied health professionals that can increase efficiency and contain health-care costs while improving patient care.

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COLA Inc., based in Columbia, MD, an independent, nonprofit laboratory CLIA-accreditation organization, accrediting more than 7,000 clinical diagnostic labs on July, 2013, launched a new education subsidiary, COLA Resources Inc. (CRI®), whose mission is to “Provide educational & consultative services aimed at improving laboratory medicine and patient care.”

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Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to market its Vitamin D assay for Clinical Chemistry Analyzers. In line with the rapid increasing clinical demands for testing of this important biomarker, Diazyme’s new Vitamin D assay, utilizing its femtoquantTM technology (a sensitive homogenous enzyme-immunoassay platform), provides the first fully automated Vitamin D test for use on general clinical chemistry analyzers. Diazyme’s Vitamin D assay measures total 25-hydroxy Vitamin D (sum of 25-(OH)D3 + 25-(OH)D2 ) levels.

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Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information and services, today announced that its Focus Diagnostics products business has received expedited FDA 510(k) clearance and CLIA moderate complexity categorization for its new Simplexa™ HSV 1 & 2 Direct molecular test on the 3M Integrated Cycler. The test, which is now available for purchase in the United States, is the first molecular test to be cleared by the FDA for the qualitative detection and differentiation of herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2) in cerebrospinal fluid (CSF) from patients suspected of HSV central nervous system (CNS) infection, including encephalitis. The test uses a proprietary process that eliminates nucleic acid extraction, so clinicians can expect results within about an hour after providing a specimen for testing.

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In Q3 of 2013, Randox announced that the Food and Drug Administration has approved the company’s Acusera Immunoassay Speciality 1 quality control for use in US laboratories.

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Randox Laboratories has further expanded its market presence in the United States, having been awarded a major supplier agreement with Novation, the leading health care supply chain expertise, analytics and contracting company.

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Spark Holland B.V. is pleased to announce the publication of US patent no. US 8586382 B2 which relates to a method and an apparatus for desorption of a blood sample from a medical test sheet comprising at least one dried blood spot (DBS) for the purpose of biomedical analysis of the blood sample. The patent allows that the new method eliminates the need for first punching out a disc area of the test sheet containing dried blood sample, thus speeding up the procedure considerably and that on-line desorption of dried blood spots is faster and easier and allows for further automation of the process.

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UTAK Laboratories, Inc., the leading diagnostics manufacturer solely focused on quality controls, announced today the release of expanded Quality Control Panels for Amphetamines, Benzodiazepines and Barbiturates used in drug screening. “Through analysis of orders for our custom products, we noticed a trend that laboratories are requesting extensive panels of these controls, all in a single bottle, for ease of use with mass spectrometry or clinical chemistry methodologies,” said Jim Plutchak, CEO of UTAK.

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OEM and custom development systems / liquid handling system / DNA extraction workstation / ABO Blood grouping system / PCR test processing

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Addcare Bio-Tech Co., Ltd. provides advanced liquid handling systems, automated immunoassay workstations and customized systems. We create solutions for a wide range of applications by combining our proprietary liquid handling technology with a variety of platforms and modules, each designed to handle a specific task in the configuration.

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Beckman Coulter Diagnostics, a global leader in prostate cancer diagnostics, announces national availability of the Prostate Health Index (phi)*, a simple, non-invasive blood test that is three times more specific in detecting prostate cancer1 than PSA (prostate-specific antigen).

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Chemclin provides a wide range of chemiluminescent immunoassays for in-vitro diagnosis, covering infectious diseases, tumor markers, thyroid functions, fertility, diabetes, liver fibrosis and other panels. Most of them are CE certified and all of them are designed for both the semi-automated (Chemclin®100) and fully automated (Chemclin®600) chemiluminescent immunosystems in quantitative and qualitative determinations.

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Chemclin’s HIV kits are available for in-vitro qualitative determination of Antibody to Human Immunodeficiency Virus Type 1 and Type 2 (Anti-HIV 1+2) and P24 antigen of HIV in human serum or plasma by a sandwich chemiluminescent assay method.

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As a manufacturer of reagents, AESKU.DIAGNOSTICS has a great understanding of the automation needs faced by end-users when handling diagnostic products on a daily basis.

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Chemclin’s Anti-TP assay provides components for in-vitro qualitative determination of Antibody to Treponema Pallidum (Anti-TP) in human serum or plasma by a double - antigen sandwich chemiluminescent assay method.

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Chemclin provides a wide range of chemiluminescent immunoassays for in-vitro diagnosis, covering infectious diseases, tumor markers, thyroid functions, fertility, diabetes, liver fibrosis and other panels. Most of them are CE certified and all of them are designed for both the semi-automated (Chemclin®100) and fully automated (Chemclin®600) chemiluminescent immunosystems in quantitative and qualitative determinations.

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Chemclin’s HIV kits are available for in-vitro qualitative determination of Antibody to Human Immunodeficiency Virus Type 1 and Type 2 (Anti-HIV 1+2) and P24 antigen of HIV in human serum or plasma by a sandwich chemiluminescent assay method.

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Chemclin’s Anti-TP assay provides components for in-vitro qualitative determination of Antibody to Treponema Pallidum (Anti-TP) in human serum or plasma by a double - antigen sandwich chemiluminescent assay method.

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Chemclin’s new Vitamin D assay provides components for in-vitro quantitative determination of 25-Hydroxy Vitamin D (25-OH Vitamin D) in human serum by a competitive chemiluminescent assay method.

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Chemclin’s Anti-TB assay provides components for in-vitro qualitative determination of Antibody to Mycobacterium Tuberculosis (Anti-TB) in human serum or plasma by an indirect chemiluminescent assay method.

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Applied and effortless simplicity of Burkert products have always been something to rely on – now we have added pure flexibility to the list of standards you can expect. The unique Pneumatic Dosing unit from Burkert – ultra precision and repeatability of fluid dosing come together with a flexible, customizable design giving you precisely the results that matter to you. Whether your world is dosing pharma media or syrup, vaccines or coffee flavors, wide ranging performance just met your changing needs.

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As a leading educator in laboratory medicine, COLA Resources Inc.’s (CRI®) goal is to continually update our education platform to reflect and support education regarding changes in regulatory requirements. The most recent regulatory changes impacting the clinical laboratory is the Centers for Medicare and Medicaid Services (CMS) new Individualized Quality Control Plan (IQCP) quality control interpretive guidelines. CRI®’s IQCP program is designed to assist clinical laboratories develop and implement their own individualized quality control. The program contains an innovative and intuitive software program IQCP E-Optimizer™ and an IQCP Implementation Guide.

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Attending the CRI® Symposium for Clinical Laboratories, affords participants the opportunity to participate in discussions centered on EDUCATION FOR LABORATORY EXCELLENCE – making a positive impact for quality patient care. This year’s symposium will be held October 15-18, 2014 at the Buena Vista Palace Hotel & Spa Lake Buena Vista (Orlando), FL. Participants can attend a wide selection of educational sessions, earn up to 20 CME or P.A.C.E® credits, network with other healthcare professionals and visit the exhibit hall featuring the latest laboratory technology, equipment and supplies.

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As a leading manufacturer of raw material for IVD industry, Fapon Biotech Inc. discovers, develops and provides innovative antigen, antibodies and enzymes that deliver significant benefits to IVD industry. Our large-scale capacity facilities and techniques minimize lot variability and incoming quality expense.

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Recently, the International Medical Reference Laboratory Proficiency Testing Results (RELA2013) has been published. The projects of MAKER all meet the requirements. Since 2008, MAKER has participated RELA experiments six years in a row, and the projects have been all qualified.

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IS 1200 Automatic Chemiluminescence Immunoassay System provides systematic solution for lab, integrating instrument, reagent, calibrator, and control. The combination of advanced precision analytic instrumentation and magnetic microparticle based enhanced immunoassay technology. The assay dynamic range is effectively widened and the sensitivity of detection is also dramatically increased. The accuracy is improved by the patented technologies. The system is innovative and turning point products in Chinese IVD market and also a new shining spot in global IVD industry.

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BCS-04 Semi-automatic Coagulation Analyzer uses the duel-magnetic method, comprehensive menu quickly and flexibly meets the requirement of clinical laboratory.

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As the first company obtained CNAS medical reference laboratory accreditation in China, Maker provide hundreds of high-quality products to satisfy the different needs from customers. The scientific design, comprehensive development, highest standards of quality of Maker, not only guarantee the reliability of test results, but also meet the requirements of reducing cost.

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NuAire offers a full line of Centrifuges, the Prism™ Mini is a reliable, compact, and economical personal Micro-centrifuge ideal for quick spins that can be used for a wide range of molecular biology protocols. Prism™ Mini works out of the box with a maintenance-free drive system and advanced design providing quiet operation and proper ventilation protecting temperature-sensitive samples. Prism™ Mini includes two (2) quick release interchangeable rotors with a max speed up to 6000 RPM.

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NuAire offers both Direct Heat and Water Jacket CO2 Incubators assuring the highest level of performance and dependability for optimum growth conditions. An environment is provided for storage and preservation of embryos, gametes and animal tissue cell cultures at or near body temperature. Designed to provide precise CO2, temperature, and relative humidity control promoting cell culture growth. Control mechanisms are built in to prevent contamination within the growth chamber. Programmable digital solid-state infrared [IR] CO2 Sensor provides a stable, drift-free output, making necessary corrections to the chamber environment and supports faster recovery times. The 99.99% HEPA filtration system creates an ISO Class 5 air quality inside the work chamber, creating Constant Contamination Control (C3) for a dependable contamination-free environment.

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NuAire’s Glacier -86˚C Ultralow Temperature Freezers provides laboratory professionals a safe, reliable freezer that they can depend on. Each freezer is designed with the most advanced features and benefits available for research, laboratory work, clinical and industrial applications, and has unmatched economical storage, providing the best value found in an ultralow freezer.

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NuAire® LabGard® ES and CellGard™ ES (Energy Saver) brand of Class II Biological Safety Cabinets offer the proper ergonomics, reduce energy, and improve laboratory safety.

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NuAire’s AireGard ES NU-201 Table Top and NU-301 Console Horizontal Laminar Airflow Hoods provide a HEPA filtered clean work area that is ideal for operations requiring a particle-free, bacteria-free, clean air environment. The Class 5 clean work area offers an excellent work space for small laboratory appliances, microscopes, pipetting, sterile drug preparations, IV admixture preparation, or any application requiring work-in-progress protection from outside potentially harmful contaminants.

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Elevated levels of Lipoprotein(a), (Lp(a)), are considered to be both a causal risk factor and major independent genetic marker of atherosclerotic disorders. What differentiates Lipoprotein(a) testing is that the association between higher Lipoprotein(a) levels and increased CVD risk is continuous and does not depend on raised LDL levels or non-HDL cholesterol, or other CVD risk factors.

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As a more sensitive maker of renal dysfunction Randox Cystatin C offers several advantages over traditional creatinine assays. Unlike creatinine tests, Randox Cystatin C is virtually unaffected by non-renal factors including muscle mass, weight, height, age, gender, diet and drugs. This makes it particularly useful in cases where creatinine measurement is not appropriate e.g. in individuals who are obese, malnourished, who have liver disease or in infants and the elderly.

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Randox has developed a versatile range of clinical chemistry analyzers with real cost saving in mind.

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All parameters available K, Na, Cl, iCa, nCa, TCa, pH, Li, Mg, TCO2, AG.

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H618 HbA1c Meter

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Dry System, Maintenance free

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High-speed and throughput Convincing Performance Bench top and cabinet design Flexible workbench setup Intuitive and flexible software Cost-effective

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Addcare elisassist is the latest extension of addcare‘s range of automated immunoassay processing systems.