ST Genesia
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ST Genesia
The ST Genesia is a fully automated commercial analyzer system for performing thrombin generation assays (TGAs) and hence for coagulation testing. It was developed by Diagnostica Stago and was introduced by the company in 2018. Traditionally, TGAs has been conducted using partially automated methods like the calibrated automated thrombogram (CAT), which was introduced in 2003. However, the CAT is performed in a 96-well plate and requires specialized technologists to be performed. Consequently, it has seen low implementation in routine laboratories and has been more limited to research settings. Lack of standardization with the CAT has also led to difficulties in study-to-study comparisons in research. It has been said that the introduction of the ST Genesia system, which will allow TGAs to be performed more easily and also shows improved reproducibility Reproducibility, also known as replicability and repeatability, is a major principle underpinning the scientific method. For t ...
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Automation
Automation describes a wide range of technologies that reduce human intervention in processes, namely by predetermining decision criteria, subprocess relationships, and related actions, as well as embodying those predeterminations in machines. Automation has been achieved by various means including mechanical, hydraulic, pneumatic, electrical, electronic devices, and computers, usually in combination. Complicated systems, such as modern factories, airplanes, and ships typically use combinations of all of these techniques. The benefit of automation includes labor savings, reducing waste, savings in electricity costs, savings in material costs, and improvements to quality, accuracy, and precision. Automation includes the use of various equipment and control systems such as machinery, processes in factories, boilers, and heat-treating ovens, switching on telephone networks, steering, and stabilization of ships, aircraft, and other applications and vehicles with reduced hu ...
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Thrombin Generation Assay
A thrombin generation assay (TGA) or thrombin generation test (TGT) is a global coagulation assay (GCA) and type of coagulation test which can be used to assess coagulation and thrombotic risk. It is based on the potential of a plasma to generate thrombin over time, following activation of coagulation via addition of phospholipids, tissue factor, and calcium Calcium is a chemical element with the symbol Ca and atomic number 20. As an alkaline earth metal, calcium is a reactive metal that forms a dark oxide-nitride layer when exposed to air. Its physical and chemical properties are most similar to .... The results of the TGA can be output as a thrombogram or thrombin generation curve using computer software with calculation of thrombogram parameters. TGAs can be performed with methods like the semi-automated calibrated automated thrombogram (CAT) (2003) or the fully-automated ST Genesia system (2018). TGAs were first used as manual assays in the 1950s and have since become in ...
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Coagulation Testing
Blood clotting tests are the tests used for diagnostics of the hemostasis system. Coagulometer is the medical laboratory analyzer used for testing of the hemostasis system. Modern coagulometers realize different methods of activation and observation of development of blood clots in blood or in blood plasma. Classification of blood clotting tests Substantially all coagulometers used in laboratory diagnostics are based on the methods of testing of the hemostasis system created more than fifty years ago. The majority of these methods are good to detect defects in one of the hemostasis components, without diagnosing other possible defects. Another problem of the actual hemostasis system diagnostics is the thrombosis prediction, i.e. sensitivity to the patient's prethrombotic state. All the diversity of clinical tests of the blood coagulation system can be divided into 2 groups: global (integral, general) tests, and «local» (specific) tests. Global tests Global tests, also known as gl ...
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Calibrated Automated Thrombogram
The calibrated automated thrombogram (CAT or CT) is a thrombin generation assay (TGA) and global coagulation assay (GCA) which can be used as a coagulation test to assess thrombotic risk. It is the most widely used TGA. The CAT is a semi-automated test performed in a 96-well plate and requires specialized technologists to be performed. As a result, it has seen low implementation in routine laboratories and has been more limited to research settings. Lack of standardization with the CAT has also led to difficulties in study-to-study comparisons in research. However, efforts have recently been made towards standardization of the assay. An example of a specific commercial CAT is the Thrombinoscope by Thrombinoscope BV (now owned by Diagnostica Stago). The CAT can be used to measure thrombogram parameters such as the endogenous thrombin potential (ETP) and to assess activated protein C resistance (APCR). The CAT ETP-based APC resistance test is especially sensitive to estrogen-induce ...
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96-well Plate
A microplate, also known as a microtiter plate (''Microtiter'' is a registered trademark in the United States, therefore it should not be used generically without attribution), microwell plate or multiwell, is a flat plate with multiple "wells" used as small test tubes. The microplate has become a standard tool in analytical research and clinical diagnostic testing laboratories. A very common usage is in the enzyme-linked immunosorbent assay (ELISA), the basis of most modern medical diagnostic testing in humans and animals. A microplate typically has 6, 12, 24, 48, 96, 384 or 1536 sample wells arranged in a 2:3 rectangular matrix. Some microplates have been manufactured with 3456 or 9600 wells, and an "array tape" product has been developed that provides a continuous strip of microplates embossed on a flexible plastic tape. Each well of a microplate typically holds somewhere between tens of nanolitres to several millilitres of liquid. They can also be used to store dry powd ...
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Medical Technologist
A medical laboratory scientist (MLS) or clinical laboratory scientist (CLS) or medical technologist (MT) performs diagnostic testing of blood and body fluids in clinical laboratories. The scope of a medical laboratory scientist's work begins with the receipt of patient or client specimens and terminates with the delivery of test results to physicians and other healthcare providers. The utility of clinical diagnostic testing relies squarely on the validity of test methodology. To this end, much of the work done by medical laboratory scientists involves ensuring specimen quality, interpreting test results, data-logging, testing control products, performing calibration, maintenance, validation, and troubleshooting of instrumentation as well as performing statistical analyses to verify the accuracy and repeatability of testing. Medical laboratory scientists may also assist healthcare providers with test selection and specimen collection and are responsible for prompt verbal delivery o ...
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Standardization
Standardization or standardisation is the process of implementing and developing technical standards based on the consensus of different parties that include firms, users, interest groups, standards organizations and governments. Standardization can help maximize compatibility, interoperability, safety, repeatability, or quality. It can also facilitate a normalization of formerly custom processes. In social sciences, including economics, the idea of ''standardization'' is close to the solution for a coordination problem, a situation in which all parties can realize mutual gains, but only by making mutually consistent decisions. History Early examples Standard weights and measures were developed by the Indus Valley civilization.Iwata, Shigeo (2008), "Weights and Measures in the Indus Valley", ''Encyclopaedia of the History of Science, Technology, and Medicine in Non-Western Cultures (2nd edition)'' edited by Helaine Selin, pp. 2254–2255, Springer, . The centralized we ...
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Reproducibility
Reproducibility, also known as replicability and repeatability, is a major principle underpinning the scientific method. For the findings of a study to be reproducible means that results obtained by an experiment or an observational study or in a statistical analysis of a data set should be achieved again with a high degree of reliability when the study is replicated. There are different kinds of replication but typically replication studies involve different researchers using the same methodology. Only after one or several such successful replications should a result be recognized as scientific knowledge. With a narrower scope, ''reproducibility'' has been introduced in computational sciences: Any results should be documented by making all data and code available in such a way that the computations can be executed again with identical results. In recent decades, there has been a rising concern that many published scientific results fail the test of reproducibility, evoking a r ...
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Blood Tests
A blood test is a laboratory analysis performed on a blood sample that is usually extracted from a vein in the arm using a hypodermic needle, or via fingerprick. Multiple tests for specific blood components, such as a glucose test or a cholesterol test, are often grouped together into one test panel called a blood panel or blood work. Blood tests are often used in health care to determine physiological and biochemical states, such as disease, mineral content, pharmaceutical drug effectiveness, and organ function. Typical clinical blood panels include a basic metabolic panel or a complete blood count. Blood tests are also used in drug tests to detect drug abuse. Extraction A venipuncture is useful as it is a minimally invasive way to obtain cells and extracellular fluid (plasma) from the body for analysis. Blood flows throughout the body, acting as a medium that provides oxygen and nutrients to tissues and carries waste products back to the excretory systems for disposal. Conseq ...
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Coagulation System
Coagulation, also known as clotting, is the process by which blood changes from a liquid to a gel, forming a blood clot. It potentially results in hemostasis, the cessation of blood loss from a damaged vessel, followed by repair. The mechanism of coagulation involves activation, adhesion and aggregation of platelets, as well as deposition and maturation of fibrin. Coagulation begins almost instantly after an injury to the endothelium lining a blood vessel. Exposure of blood to the subendothelial space initiates two processes: changes in platelets, and the exposure of subendothelial tissue factor to plasma factor VII, which ultimately leads to cross-linked fibrin formation. Platelets immediately form a plug at the site of injury; this is called ''primary hemostasis. Secondary hemostasis'' occurs simultaneously: additional coagulation (clotting) factors beyond factor VII ( listed below) respond in a cascade to form fibrin strands, which strengthen the platelet plug. Disorders of c ...
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