The Afinion Analyzer System is a concept comprising an instrument specially designed to measure various chemistries, and consequently a very wide range of tests. The reagent cartridge and the instrument are designed as closed units. A unique failsafe system supervises and logs every step during processing and measurement. This ensures that a result will never be displayed if an error occurs during sample handling or measurement.
Currently, the following tests are available:
• HbA1c test
The HbA1c Test Cartridge contains all reagents necessary for the measurement of glycated hemoglobin.
• ACR test
The Afinion ACR provides a simple, fast and convenient point of care test for determination of albumin, creatinine and albumin/creatinine ratio (ACR) in human urine, which can indicate microalbuminuria. Microalbuminuria is the first clinical sign of diabetic renal disease and cardiovascular disease. Simple testing for microalbuminuria is extremely efficient as an early indicator of renal failure.
• CRP test (not available in the US)
The Afinion CRP test is an important point of care assay to indicate bacterial or viral cause of infection. With a total assay time of only 4 minutes, the CRP test result can support the clinical diagnosis of an inflammation. Unnecessary use of antibiotics can be avoided if the CRP result indicates a viral infection.
Key features of the Afinion AS100 Analyzer
• Multiple analytes on one instrument
• Very easy to use
• Short assay times
• No mess - no maintenance
• All-in-one Reagent Cartridge
• Long shelf life of reagents
• Convenient kit size: 15 tests
• Integrated error detection system
QBC Diagnostics, Inc. to ensure customer satisfaction by providing quality products and services to the physician’s office laboratory. We will continue to make customer satisfaction our greatest concern through uncompromising quality and comprehensive customer support.
All of our employees are committed to continually ensuring the quality of the products and services we offer.
Giving you the tools to optimize medical and economic benefits, the new QBC Systems offers the most cost-effective means to achieve excellence in point-of-care hematology testing
The SoftTech Lab QMS (Quality Management System) is the first full-featured quality management system built specifically for healthcare labs. The Lab QMS was designed to help you meet quality management and accreditation/auditing needs more quickly.
With the Lab QMS, your Healthcare Lab can:
• Save measurable and significant time for all lab personnel
• Have more time to devote to lab testing and reporting
• Better comply with accreditation requirements
• Improve quality processes to provide better service
• Reduce risk with better safety QI tracking
• Optimize workloads and reduce overtime, and thereby:
• Cope with shortages of qualified lab personnel
User-friendly and intuitive, SoftTech Lab QMS will provide time savings for everyone in your lab, from bench workers to lab quality managers to chief pathologists.
The Lab QMS is one comprehensive solution to handle all your healthcare lab’s quality management needs including:
• Facilitating and demonstrating compliance for accreditation
• Document control and quality manuals
• Employee credentialing
• Tracking and reporting on Audits
• Feedback/Complaint Management.
• Online Forms Nanagement.
Document/Policy Management works with Content Management to enable you to put your P & Ps online, for huge improvements in rapid information access and patient safety. SOftTech Health Document/Policy Management integrates with the SoftTech Quality Management System to enable you to meet quality benchmarks and accreditation requirements around document control.
USB Corporation has a long-standing reputation as a leader in the life sciences, fueling innovation in basic research, drug discovery and molecular diagnostics. The company history reaches back to the 1970s, known then as United States Biochemical, a company that specialized in supplying biochemicals to the research market. In the 1980s, a collaboration with scientists (Tabor & Richardson) at Harvard University led to the commercialization of Sequenase™ DNA Polymerase and the first easy-to-use DNA sequencing kits. This technology pioneered development of themostable enzymes and automation for high-throughput sequencing.
USB Corporation was acquired in 2008. USB, now part of Affymetrix, supplies biochemicals and molecular biology products for research and emerging technologies. USB products include ExoSAP-IT; for PCR Clean-up, HotStart-IT; DNA Polymerases & Master Mixes for qPCR; qRT-PCR, PrepEase; purification products, Tested User Friendly™ (TUF) enzymes, Sequenase™; Thermo Sequenase™ Kits, nucleotides and biochemicals.
The principle of the assay is based on the competition between the 125 iodine labeled 17 a-hydroxyprogesterone and 17 ahydroxyprogesterone
contained in standards or specimens to be assayed for a fixed and limited number of antibody binding sites.After the incubation, the amount of labelled 17 a-hydroxyprogesterone bound to the antibody is inversely related to the amount of unlabelled 17 a-hydroxyprogesterone originally present in the sample. The method adopted for bound / free fraction separation is based on the use of coated tubes.
The principle of the assay is based on the competition between 125 Iodine labelled estradiol and estradiol contained in standards or
specimens to be assayed, for a set, limited number of antibody binding sites. After the incubation, the amount of unlabelled estradiol
originally bound to the antibody is inversely related to the amount of unlabelled estradiol present in the sample. The method adopted
for B/Fseparation is based on the use of coated tubes.
For the direct quantitative determination of Dihydrotestosteroneby enzyme immunoassay in human serum.For in vitro use only.PRINCIPLE OF THE TESTThe principle of the following enzyme immunoassay testfollows the typical competitive binding scenario. Competitionoccurs between an unlabeled antigen (present in standards,control and patient samples) and an enzyme-labelled antigen(conjugate) for a limited number of antibody binding sites onthe microwell plate. The washing and decanting proceduresremove unbound materials. After the washing step, theenzyme substrate is added. The enzymatic reaction isterminated by addition of the stopping solution. Theabsorbance is measured on a microtiter plate reader. Theintensity of the colour formed is inversely proportional to theconcentration of DHT in the sample. A set of standards isused to plot a standard curve from which the amount of DHT inpatient samples and controls can be directly read.
QIAGEN N.V., a Netherlands holding company, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make such isolated biomolecules visible. QIAGEN has developed and markets more than 500 consumable products as well as automated solutions for such consumables. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the digene HPV Test, which is regarded as the "gold standard" in testing for high-risk types of human papillomavirus (HPV), the primary cause of cervical cancer. QIAGEN employs more than 3,000 people in over 30 locations worldwide. Further information about QIAGEN can be found at http://www.qiagen.com/.
For the direct quantitative determination of 3α Diol G by
enzyme immunoassay in human serum.
For non-clinical research use only.
PRINCIPLE OF THE TEST
The principle of the following enzyme immunoassay test
follows the typical competitive binding scenario. Competition
occurs between an unlabeled antigen (present in standards,
control and patient samples) and an enzyme-labelled antigen
(conjugate) for a limited number of antibody binding sites on
the microwell plate. The washing and decanting procedures
remove unbound materials. After the washing step, the
enzyme substrate is added. The enzymatic reaction is
terminated by addition of the stopping solution. The
absorbance is measured on a microtiter plate reader. The
intensity of the colour formed is inversely proportional to the
concentration of 3α Diol G in the sample. A set of standards is
used to plot a standard curve from which the amount of
3α Diol G in patient samples and controls can be directly read.
CLINICAL APPLICATIONS
5α-Androstane-3α, 17β-diol glucuronide is a C19 steroid and is
either abbreviated as 3α Diol G, 5α Diol G or simply, α Diol G.
It is produced mainly as a metabolite of testosterone and

G-Biosciences offers a wide range of research tools and reagents for proteins, DNA, RNA and more.
Built around the many positive attributes of the IMMULITE 2000, the IMMULITE 2500 includes the very important addition of Logic Driven Incubation (LDI). Using a newly designed incubator, LDI technology allows assays to be formatted for optimal performance with the fastest possible incubation time. This means certain assays, such as Siemens' cardiac biomarkers and HCG, can now be run in 15 minutes. The IMMULITE 2500 was developed on the basis of customer feedback and market trends as a highly productive and efficient system for medium- and high-volume routine immunoassay laboratories, with a throughput of up to 200 tests per hour.
With the addition of the VersaCell™ system to our complete line of immunoassay analyzers and automation products, Siemens is now able to offer optimal solutions to every type of customer.
The IMMULITE 1000 immunoassay system features an extensive menu, ease of use, reliability, robust hardware and excellent assay performance. The IMMULITE 1000 monitors onboard reagents and accommodates onboard dilutions, positive sample identification, and Remote Diagnostics.
Worldwide, IMMULITE 1000 (and its predecessor, the IMMULITE) has been chosen for various types of immunoassay testing due to their flexible platforms, breadth of menu, ease of use, reliability, high-performance assays and fully integrated operation. Assays for cardiac biomarkers, thyroid function, reproductive endocrinology, infectious disease, TDM, serology, anemia, drugs of abuse, diabetes, tumor markers and esoterics are all easily run with true random access capability.
Turbo capabilities provide results in 15 minutes for critical STAT assays including the cardiac biomarkers Troponin I, CK-MB, and Myoglobin, as well as Intact PTH and HCG.
The IMMULITE 1000—designed to meet the immunoassay testing needs of the clinical laboratory today and tomorrow.
The IMMULITE 2000, a continuous random access analyzer with a processing throughput of 200 tests per hour, has been designed specifically for optimum efficiency and consolidation in medium- and high-volume laboratories. The IMMULITE 2000 software package, with its self-explanatory graphical user interface, offers streamlined information management, from remote test ordering to sophisticated analysis of results. Workflow-enhancing features such as primary tube sampling, automatic reflex testing and onboard dilution have been incorporated for speed and efficiency.
The ADVIA® 1200 system features a small footprint, which allows it to fit comfortably in any size laboratory.
Standardization as Part of the ADVIA Chemistry Family
The ADVIA 1200 system uses the same reagents, calibrators and controls as the other members of the ADVIA Chemistry family and is based on the same proven reliability.
Meets Workload Needs
With the speed of 1200 tests per hour, the ADVIA 1200 system can keep up with workload requirements whether it is acting as a primary analyzer or as a backup to another system.
The ADVIA® 1650 has minimal requirements for sample volume (as low as 2 µL/test), reagent consumption (as low as 80 µL/test) and water consumption (25 L/hour) - thus maximizing management efficiency.
Outstanding productivity
A rapid, 3-second cycle and system throughput of up to 1650 tests/hour provide powerful high-speed performance, ensure workflow efficiency through peak workloads. Optional universal rack handler facilitates continuous sample feeding for further productivity gains.
Unparalleled walkaway capability
On-board capacity of 200 samples and 32,000 tests - plus our exclusive Sample Saver Technology for automatic repeat, dilution and reflex testing without operator intervention - optimizes walkaway time, frees you to work on additional tasks.
Expertise in automation
For 50 years we have been recognized for our innovation - just as clinical chemistry has been recognized as the driver of automation. The tradition continues. The ADVIA 1650 can be integrated with other testing disciplines via the ADVIA WorkCell™ or ADVIA LabCell® automated sample transportation systems.
The ADVIA® 2400 Chemistry System pushes your laboratory’s productivity levels while maintaining the reliability and stability that keep you up and running. A rapid 2-second probe cycle time maximizes tube speed and test throughput, and combined with the system’s efficient automation-readiness, gives you the turnaround time your high-volume laboratory needs.
Superior Speed and Productivity
• Up to 2400 tests/hour (1800 photometric and 600 ISE)
• Rapid, consistent 2-second cycle time
• Top-of-class throughput of 200 tubes per hour when running ISEs and up to 9 photometric tests
• Automatic Sample Retain technology, auto-repeat, auto-dilution and auto-reflex testing
Automation Ready
• Point-in-space aspiration offers connectivity to track or rack handler without robotics or special hardware
• Redundant sample loading for built-in backup and easy handling of non-routine samples
• Direct sampling from track prevents detaining tubes at analyzer and reduces aliquoting
Minimal Intervention Demands
• Minimal-maintenance ISE
• No-maintenance 37oC incubation fluorocarbon bath oil
• Auto-calibration and auto-QC from refrigerated onboard calibrator and controls
• Microvolume technology with 32,000 tests onboard and up to 60 days onboard stability maximizes walkaway times
Exceptional Reliability
• Sample integrity check for icterus, hemolysis and lipemia
• Sample probe with automatic clot/clog detection, liquid level sensing, short sample detection and crash protection
• Advances in reagent onboard stability, calibration frequency, interference reduction and linearity expansion
The ADVIA 1800 system is the new standard in chemistry analysis. Featuring intuitive new software and capabilities, it’s designed to deliver power and speed to meet your most demanding performance needs. Choose the ADVIA 1800 system and move your lab to smarter chemistry testing.
Automation Ready
• Point-in-space aspiration offers connectivity to track or rack handler without robotics or special hardware
• Redundant sample loading for built-in backup and easy handling of non-routine samples
• Direct sampling from track prevents detaining tubes at analyzer and reduces aliquoting
Peak Productivity
• 1800 tests per hour provides speed to keep pace with workload peaks
• 200 Basic Metabolic Panels per hour to meet turnaroundtime demands
• Automatic Sample Retain technology provides ability to perform reruns and dilutions without need to retrieve primary tube
• Consolidation power with a comprehensive menu, consistent cycle times, unsurpassed speed and open applications
Total System Reliability
• Robust hardware and simplified software design, with automatic calibration validation and tracking
• Advances in reagent onboard stability, calibration frequency, interference reduction and linearity expansion
• Direct water connection
• Remote diagnostics and ILQC (Inter-Laboratory Quality Control) options
Easy Efficiency
• Large onboard reagent capacity reduces interruptions
• High-resolution touch screen delivers push-button operation
• Reagent Pause capability and onboard Sample Pause button make loading easier
• Minimal maintenance requirements, including unique no-maintenance oil bath
• Sample integrity checking, including serum indices, short sample and clot detection, reduces manual intervention
The Diamedix Immunosimplicity® Is-ENA-6 Screen Test Kit is an EIA procedure intended for the detection of IgG antibodies to six ENAs. Positive samples can be further evaluated using specific ENA test kits.
Each Is-ENA-6 Screen Test Kit contains reagents for 96 tests.
75mm x 0.56mm BD Vacutainer® Pre-Cal Microhematocrit tube with Pre-calibrated Ammonium Heparin additive Plastic clad (200/sp, 1000/ca)
Combines the precision of glass with the safety of a multi-layered Mylar wrap. Mylar is a hardy, durable and transparent plastic. The benefits of Mylar wrapped glass over simple glass are:
• it protects the healthcare worker from exposure to blood-borne pathogens through the containment of glass fragments in the event of breakage
• significantly reduces sample leakage
BioNexia® hCG Combo is a chromatographic immunoassay (CIA) for the rapid qualitative detection of hCG in urine and serum samples.
Human Chorionic Gonadotropin (hCG) is a glycoprotein hormone secreted by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected in the urine or serum of pregnant women as early as seven days after conception. The concentration of hCG rises very rapidly, frequently exceeding a value of 100 mIU/mL by the first missed menstrual period, and finally peaking in the 30000-100000 mIU/mL range about 10-12 weeks into pregnancy. The appearance of hCG soon after fertilization and its subsequent rise in concentration during early gestational growth make it an excellent marker for the early detection of pregnancy.
BioNexia® hCG Combo has been developed for the rapid detection of the pregnancy hormone hCG in urine or serum samples with a sensitivity of 20 mIU/mL. The test kit uses monoclonal antibodies to detect the concentration of hCG in urine or serum. BioNexia® hCG Combo shows no cross-reactivity with structurally related hormones (FSH, LH, TSH) in normal maximum physiological concentrations.
Tecan is a provider of tools and solutions to the world’s pharma, biotech, diagnostic, forensic and basic research laboratories and companies. As a global leader in laboratory automation for more than 25 years Tecan products cover laboratory process automation from sample storage across liquid handling and robotics to optical sample detection and result analysis. The solutions accelerate, automate and enhance processes in state-of-the-art life-science laboratories, enabling customers to generate vital insights faster, safer and more efficiently. Tecan is active both through a global direct sales and service force and as OEM provider to leading diagnostic companies.
Thomson Reuters is the leading provider of decision support solutions that help organizations across the healthcare industry improve clinical and business performance. It is built on the strength of leading healthcare brands including Medstat, MercuryMD, Micromedex, PDR, and Solucient. Through these offerings, Thomson Reuters provides the solutions, information, insight, and analysis its healthcare customers need to manage healthcare cost, quality, market positioning, and enterprise growth.
A Rapid, Visual Chromatographic Assay for Detection of HCV Antibodies
Two tests are available: serum or plasma test and whole blood, serum or plasma test
Sensitivity: 99
Specificity: 97
Panel confirmation: 100
Less than 1 minute hand-on time
Multiple independent clinical studies
LIMS - Laboratory Information Management Systems
STARLIMS Corporation supplies powerful Laboratory Informatics solutions—based on an award-winning LIMS platform that is entirely web-based and fully configurable. STARLIMS’s Web-based off-the-shelf solutions are designed for a wide array of laboratory environments, operating in various disciplines and industries. Analytical, research and testing organizations depend on STARLIMS® to structure and manage their most complex workflows and laboratory processes.
Achieving scientific, performance and regulatory goals
STARLIMS solutions enable labs to manage complex processes, ensure regulatory compliance, and promote enterprise-wide collaboration.
100 Percent Web-Based Platform
Built from the ground up as an entirely web-based application, STARLIMS incorporates LIMS, SDMS and ELN into a single integrated platform. It represents an important step beyond traditional web-enabled LIMS.
LIMS Experts for 20 Years
STARLIMS has hundreds of successful LIMS implementations across the globe, in the pharmaceutical, public health, petrochemical, forensics, food & beverage, water, environmental and chemical sectors.
Phadebas® consists of biodegradable globular microspheres (DSM) of defined size, formed by homogeneously interlinking starch polymers. Within the DSMs, a blue dye is covalently bound to the polymer chains. When the dye is bound to the microsphere, it remains water insoluble. However, in the presence of Amylase, the DSM is degraded at a speed proportional to the Amylase activity, and the blue dye is liberated. The characteristics of the now liberated blue dye molecule is the key for Phadebas action. The free dye molecule is water soluble and its concentration measurable at 620 nm. Using a fixed assay time, the absorbance reading gives the solution's Amylase activity, through the standard curve supplied with each kit.
Sigma-Aldrich is a leading Life Science and High Technology company. Our biochemical and organic chemical products and kits are used in scientific and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical and other high technology manufacturing.
We have customers in life science companies, university and government institutions, hospitals and in industry. Sigma-Aldrich operates in 35 countries and has over 6,800 employees providing excellent service worldwide.
MedMira is a leading developer and manufacturer of flow-through rapid diagnostics. The company's tests provide hospitals, labs, clinics and individuals with reliable, rapid diagnosis for diseases such as HIV and hepatitis C in just three minutes. The company's tests are sold under the Reveal(R), MiraWell(R), MiraCare(TM) and Multiplo(TM) brands in global markets. MedMira's rapid HIV test is the only one in the world to achieve regulatory approvals in Canada, the United States, China and the European Union. MedMira's corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada. For more information visit MedMira's website at
www.medmira.com.
Posted by Jim Marino on January 2, 2009
Ortho Clinical Diagnostics announced 510(k) clearance from the United States Food and Drug Administration (U.S. FDA) for its VITROS(R) 3600 Immunodiagnostic System. This new high-capacity immunoassay system provides laboratories with a truly innovative solution to address their quality, labor and cost challenges. The VITROS(R) 3600 delivers high-quality and dependable results by offering a broad and comprehensive immunoassay menu based on world-class VITROS(R) technologies. This is the second clearance for Ortho Clinical Diagnostics this quarter, following 510(k) clearance of the VITROS(R) 5600 Integrated System in October.
Posted by Jim Marino on December 17, 2008
NovoCure Ltd has evaluated the Novo-TTF device in vitro and in a pilot clinical trial that showed the device enhanced the efficacy of standard chemotherapy (temozolomide) treatment in newly-diagnosed glioblastoma multiforme (GBM) patients. When used in combination with standard chemotherapy, the Novo-TTF, a non-invasive medical device that uses low intensity alternating electric fields to destroy cancer cells, enhanced the anti-tumor effects of standard chemotherapy, thus prolonging time to disease progression and extending survival. Patients in the study did not experience any device-related, systemic, adverse events.
Posted by Jim Marino on December 9, 2008
Asuragen, Inc. has announced that the Signature(R) LTx v2.0 Leukemia Translocation Panel was released as a “Conformite Europeenne” or “European Conformity” CE IVD product under the European Directive on In Vitro Diagnostic Medical Devices. The CE-marked Signature(R) LTx v2.0 is a qualitative in vitro diagnostic device for use in a clinical laboratory to identify specific fusion transcripts in total RNA from whole blood or bone marrow to aid in the clinical diagnosis of translocation positive leukemias. Clinical validation studies showed 100% diagnostic accuracy in comparison to standard cytogenetic methods. This represents the world’s first Luminex-based molecular oncology IVD product.
Posted by Jim Marino on November 28, 2008
Siemens Healthcare has launched a NEW-GENERATION, superfast CT scanner that requires only a fraction of the radiation dose usually used in imaging techniques . The SOMATOM Definition Flash is a dual source device featuring two x-ray tubes which simultaneously revolve around the patient’s body, scanning even the tiniest anatomical details at a faster speed than ever before and with a much lower dose of radiation. The scanner can check the entire heart in just 250 milliseconds – less than half a heartbeat and can also image hearts with a fast or irregular beat without the need for beta blockers.
Posted by Jim Marino on November 17, 2008
MDS Analytical Technologies has announced that the Abraxis Melamine Detection Kit has been validated for use on company’s SpectraMax(R) absorbance microplate readers with SoftMax(R) Pro 5 GxP analytical software. The product offers a cost-effective, high-throughput, quality-assurance solution to detect melamine contamination in such food products as milk, infant formula, pet food, and confectionery. This solution further enables the company to expand its offering in applied markets. MDS Analytical Technologies also offers a mass spectrometry-based solution for food safety testing.
Posted by Jim Marino on November 6, 2008
Biohit has expanded its collection of diagnostic tests for gastro-intestinal diseases by launching its ColonView Hb and Hb/Hp quick tests. Developed for a faster detection and prevention of colorectal cancer, the ColonView quick tests are a simple and cost-effective solution. The testing will facilitate the diagnosis of patients with fecal occult blood (a major marker for colorectal cancer and pre-cancerous large adenomas). Also, the tests will help in identification of other diseases associated with bleeding.
Posted by Jim Marino on October 29, 2008
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has renewed the marketing authorization for Zila, Inc.’s OraTest® for an indefinite period. This allows the company to sell its proprietary diagnostic kit for oral cancer in seven European countries with a combined population of 100 million. OraTest is indicated as an add-on to visual examination for patients having high risk of high-grade malignant lesions. It can also be used to screen patients who have received treatment for oral squamous cell carcinoma. The kit has pharmaceutical grade tolonium chloride rinse product which is patented with Zila.
Posted by Jim Marino on October 27, 2008
Scientists from Finland and Sweden have developed an innovative tool to identify parasites through the use of virtual microscopy online. The web-based diagnostic will be able to detect diseases caused by parasites such as malaria and amebiasis. The researchers believe that this method has the potential to improve the standards of diagnostics related to parasite-related diseases in low income countries. Karolinska Institutet (Sweden) and the Universities of Helsinki, Tampere, and Léon.
Posted by Jim Marino on October 23, 2008
SiDMAP, LLC, has expanded its SiDTox™ services to enable rapid and specific detection of drug-induced organ toxicity. Using its proprietary metabolomics technology platform, SiDMAP is able to monitor changes in vital metabolite fluxes in response to drug treatment to quickly determine organ toxicity before structural or morphological damage occurs. On the basis of a research performed by SiDMAP along with the Center for Metabolomics at the FDA National Center for Toxicological Research, SiDTox™ will now include an affordable and non-invasive test that will allow researchers to detect drug-induced toxicity before organ damage.
Posted by Jim Marino on October 23, 2008
InfraScan has received the European marketing clearance (CE mark), for its handheld brain hematoma detector. This approval certifies that Infrascanner has met all the safety, health and environmental standards set up by European Union (EU). The diagnostic device is the first of its kind used for identification of fatal brain hematomas, thereby facilitating treatment critical to the recovery of patients. A portable device, Infrascanner is now pursuing applications for monitoring stroke victims with the use of the same technology.
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