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Coagulation Instruments and Reagents

Dynamic And Quantitative Analysis Of Blood Coagulation

The new portable and battery-operated optical sensor instruments can rapidly quantify PT/INR within seconds by measuring alterations in the viscoelastic properties in a drop of whole blood.

Thrombosis is one of the leading causes of mortality worldwide. The proper estimation of hemostasis/coagulation status is necessary to diagnose the pathology, manage treatment, and select adequate doses of anticoagulants. Many instruments analyze separate aspects of the coagulation system. These instruments primarily measure the concentrations of individual coagulation factors and inhibitors or characterize separate subsystems of hemostasis. However, the overall functional activity of the complex and multi-component hemostasis system cannot be accurately described using measurements of the concentrations of the separate system components. Such an assessment requires a global (integral) functional testing menu that measures the total result of all hemostasis reactions under conditions that mimic the situation in vivo.

Keeping this in view, a wide range of tests such as PT, APTT, FBG, TT, factors, Lupus, and D Dimer, in addition to the basic clot detection method, have been introduced in new systems, thereby expanding the test menu. The semi-automated single-channel instruments have seen significant advances in the recent past. Small semi-automated systems are in demand by laboratories with low workload. Customers prefer systems that meet their basic requirements and are capable of testing other parameters such as fibrinogen, factors, lupus, or D dimer. Medium workload users prefer fully automated four-channel systems. Fully automated systems are now offering higher throughput to meet the needs of laboratories with high demand. Availability of advanced software with LJ graphs and calibration curves has further improved the accuracy and precision of reporting. Instrument interfacing to LIS and specimen bar coding capabilities reduce the dependence on manual record maintenance.

Moreover, given the requirement to transport and centrifuge the specimen, the conventional coagulation testing (CCT) turnaround time was often too long (~1 hour) to be reliable for informing treatment decisions particularly in the context of rapidly changing coagulation conditions in critically ill or injured patients. To address the need for rapid coagulation testing at the patient’s bedside, new approaches for measuring prothrombin time (PT) and international normalized ratio (INR) in whole blood have been recently developed and commercialized. Lowering the cost of PT/INR testing in the hospital setting may further reduce overall healthcare costs associated with coagulation testing while potentially improving patient outcome.

Technological advances
Current instruments are witnessing huge transformation in terms of design and function owing to the fact that coagulation plays a critical role in diagnostics and hence customers expect systems with precise and consistent reporting.

PoC assays. Numerous point-of-care (PoC) assays are now available for various types of coagulation tests. These assays are easy to perform and their main advantage is that they possess a faster turnaround time than their laboratory counterparts. Portability, easy usage, and connectivity are the factors that are increasing demand for PoC testing. In order to control the adverse effects of anticoagulation therapy, immediate results of coagulation testing are needed, and this demand is met by the PoC assays that provide accurate and quick results.

Electromagnetic induction sensor. With the increasing demand for coagulation PoC testing for patients in the surgery department or the ICU, rapid coagulation testing technologies have drawn widespread attention from physicians and businessmen. The use of electromagnetic induction sensor probes for detection of dynamic process causing changes in the blood viscosity and density before and after coagulation based on the damped vibration principle may become a new trend in order to evaluate the coagulation status. The electromagnetic induction coagulation testing sensors have a good elasticity and anti-fatigue, which can meet the accuracy requirement of clinical detection.

Thrombus elasticity measurement technology. Since in the blood coagulation, the blood viscoelasticity changes, therefore, the thrombus elasticity measurement technology can be used to continuously monitor the process of coagulation by bedside detection. The traditional electromagnetic induction sensors, based on conventional coil inductance, are manufactured complexly, have a high cost, and are non-linear. The thrombosis elastic map (TEM) obtained by data and image processing, can illustrate the whole process of the interaction of all the various components in blood coagulation and fibrinolysis. Consequently, it can allow doctors to detect the patients’ blood coagulation function accurately without damage in the perioperative period and make rapid diagnosis and highly stable treatment programs. At present, different kinds of blood viscoelasticity measurement are employed, including thromboelastography (TEG), rotation thrombosis elastometer (ROTEM), and Sienco platelet function instrument (Sonoclot).

Laser speckle rheology sensor. PT and the associated INR are routinely tested to assess the risk of bleeding or thrombosis and to monitor response to anticoagulant therapy in patients. To measure PT/INR, CCT is performed, which is time-consuming and requires the separation of cellular components from whole blood. The new portable and battery-operated optical sensor can rapidly quantify PT/INR within seconds by measuring alterations in the viscoelastic properties of a drop of whole blood following activation of coagulation from a time series of laser speckle patterns (a random intensity pattern that occurs by the interference of coherent light scattered from tissue).

Advances in instruments. The current handheld instruments are accurate, convenient, and user-friendly and come with improved safety features that protect operators during the course of the testing process. They provide quick, quantitative results across the reportable range and guide users during operation through step-by-step pictorial prompts. Using single-use reagent test strips that contain dried reagents and electrochemical technology, the new instruments offer PT measurement and quality checks for error-free data capture.

Computational modeling. Despite the advancements, understanding about the blood clotting process is incomplete and still evolving. The developments in computational methods like molecular simulations, mesoscopic methods, and continuum theories promise a synergetic solution to various kinds of problems. The trend of the computational modeling over the years shows that the simpler models like single component continuum models are becoming redundant and increasingly replaced with discrete particle methods like DPD and with the emerging technique called multiscale modeling.

The global coagulation instrument market valued at USD 2481.7 million in 2017 is projected to exhibit a CAGR of 9.7 percent from 2018 to 2025, says a Coherent Market Insights report. Introduction of new coagulation instruments by manufacturers to perform various functions such as cap piercing, primary tube sampling, dilution, and automatic rerun is expected to push demand. Furthermore, manufacturers are emphasizing on providing cost-effective instruments to small and medium-sized diagnostic laboratories. This is owing to these laboratories focusing on expanding in emerging economies, which have less diagnostic centers, due to low disposable income and lack of infrastructure.

In India, the coagulation market is expected to grow steadily. The lower and mid segments are growing at twice the pace with the introduction of new products every year. Specialized tests are being added to the higher segment to cater to the needs of the high end customers. In the coming years, numerous diagnostic centers will be established in rural areas propelled by improved diagnostic tools, enhanced treatment monitoring, increased availability of over-the-counter tests, easy availability of coagulation solutions at affordable prices, and high investments from the private sector. High-throughput results, increasing adoption of automation, and development of high sensitivity and specificity of coagulation instruments will drive the market growth in the years to come.

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