NewsLab Informatics
FDA Laboratories Install Abbott’s LIMS Technology
20 Jan 2012
Sonia Nicholas
Managing Editor and Clinical Lead
Product news
Abbott has announced that the U.S. Food and Drug Administration (FDA) is to install Abbott’s STARLIMS® software-based laboratory information management system (LIMS) as part of the agency’s initiative to enhance FDA testing laboratories.
The STARLIMS software is a high-performance, totally web-based LIMS. It provides all of the features required to manage the workflow and resources of the laboratory whilst enabling enterprise-wide access to lab data. The software is ideally suited to managing the complex processes and vast amounts of information generated by FDA laboratories.
As part of a master agreement with Dovel Technologies, a company that provides high-end software applications to government organizations, the FDA’s Office of Regulatory Affairs (ORA) will begin deploying LIMS solutions from STARMLIMS designed to enhance testing of food and drug chemistries, devices, forensics material and microbiology. The LIMS solution will provide the capability required to manage the analytical workflow operations in ORA labs for approximately 825 users. The system supports sample accountability, data analysis, document control, report generation, and other lab operation functions.
"We're looking forward to working on this important initiative," said Isaac Friedman, head of Abbott's STARLIMS business. "STARLIMS has a successful track record in implementing web-based LIMS for life sciences organizations, public health laboratories and a number of federal agencies."
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LIMSLIMS (Laboratory Information Management System) is an informatics software system used to improve the quality assurance and quality control (QA / QC) of data management. LIMS can be a standard for common lab workflows, such as commercial off the shelf systems (COTS), or customized for more specialized lab use. Systems are available for mainframe computers or PC.MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Blood TransfusionBlood Transfusion involves giving donor blood to a recipient patient. Screening is essential to avoid transfusion reactions. Blood banks use immunohematological techniques to determine rh and ABO blood group, and screen for antibodies using specific antisera. Blood Banks use Direct Coombs Tests (DCT) and Indirect Coombs Tests (IAT) to detect hemolysis and Haemolytic Disease of the Newborn (HDN).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.Cellular PathologyCellular Pathology deals with the microscopic analysis of tissue samples and cells. Sample preparation and processing includes fixation, staining, sectioning and slide mounting, using equipment such microtomes and cryostats. In choosing immunohistochemistry and immunocytochemistry kits, consider chromogens, staining method, antibodies, microscopes and imaging.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.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.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.Clinical MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Embryology / IVFEmbryology refers to the development of an embryo resulting from the fertilization of the ovum, to fetus stage. In vitro fertilization (IVF) refers to the fertilization of the egg outside of the human body, and is an important treatment for infertility.Evidence Collection and AnalysisEvidence Collection and Analysis is the retrieval and subsequent investigation into criminal evidence obtained from a crime scene. Forensic genetic instruments, kits and reagents enable the analysis of evidence collected at the crime scene. Reagents and kits for presumptive analysis for body fluids such as blood, saliva and semen in addition to drugs and narcotics test kits are used for CSI. Fingerprinting equipment, forensic light sources, casting kits and equipment for collecting recoverable materials can be found in the directory.FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices.