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Coagulation Instruments and Reagents

Automation Gains Pace

New generation of coagulation analyzers is fully automated, and combines several technologies in the same instrument to perform wide range of different coagulation assays on a single or multiple samples at the same time.

Millions of patients use anticoagulant drugs to treat atrial fibrillation, pulmonary embolism, phlebothrombosis, and other diseases. For these patients, it is very important to keep the blood rheological parameters on an appropriate level in daily life to avoid the risk of thrombus or bleeding. Since the early history of the hemostasis laboratory, coagulation analyzers have been mostly designed for running clotting tests. In recent decades, however, these instruments have become increasingly equipped with additional technical tools to perform a broader test menu for the investigation of bleeding and thrombotic disorders. The current generation of coagulation analyzers is fully automated, and combines several technologies in the same instrument. By using clotting, chromogenic, and immunological methods for quantication of basic and specic hemostatic parameters, they are designed for the screening of a large number of samples, with capabilities for performing a wide range of different coagulation assays on a single or on multiple samples at the same time.

The need to monitor anticoagulation during and after surgery is also one of the major reasons that the cardiac surgical arena has evolved into a major site for the evaluation and use of hemostasis monitors. The rapid and accurate identification of abnormal hemostasis has been the major impetus toward the development of point-of-care tests that can be performed at the bedside or in the operating room. The latestpoint-of-care (PoC) coagulation analyzers generate timely results without sacrificing the diagnostic quality controls provided by the central lab. Moreover, recent devices provide both electronic and internal QC checks on test strips. Convenient device test strip eject mechanisms allow safe disposal of used strips to minimize operator exposure to potential contamination from patient blood.

The consumer demand for blood coagulation analyzers has led to a shift in diagnostic testing from hospitals and commercial laboratories to the patient’s home. India has a high percentage of people living in rural areas, which have less diagnostic centers due to a lack of infrastructure and low disposable income. This has led to less spending on basic healthcare facilities in rural areas. As a result, several diagnostic testing solutions providers are trying to venture into the country in order to capitalize on the untapped diagnostic testing market in the future.

In the coming years, numerous diagnostic centers will be established in rural areas owing to factors like improved diagnostic tools, enhanced treatment monitoring, increased availability of over-the-counter tests, easy availability of coagulation solutions at cheaper prices, and high investments from the private sector. This will lead to the growth of this market and provide huge opportunities for coagulation analyzer manufacturers.

Technology Trends
Currently, the widely-used coagulometers mainly are based on the detection of the change of blood viscosity during the coagulation process by paramagnetic particle methods or optical methods. Automation in coagulation testing has enabled laboratories to function more cost-effectively by improving the throughput of samples and by reliability of coagulation assays. There are a number of different automated coagulation analyzers that are commercially available and designed for testing a large number of samples by combining different technologies in single analyzer.

Optical fiber light beam technology. This new technology is used to monitor a patient’s blood in real-time during surgery. With constant, updated information on a patient’s blood status, surgeons can better prevent life-threatening blood clots during surgery. This technology replaces the wait time for testing after a patient’s blood is drawn. The optical fiber light beam apparatus connects to the tubes of the heart-lung machine, providing constant status updates, so if the patient needs more anticoagulant drugs, the surgeon knows immediately.

RoTEM. Assessment of hemostasis with a thromboelastography (TEG) system has been used clinically for 50 years to identify, monitor, and guide treatment of coagulopathies in both laboratories and in point-of-care facilities. The current viscoelastic hemostatic assay technology rotational thromboelastometry (RoTEM) is simpler to operate and to interpret, which allows the device to be used in a broader range of clinical settings.

TEM in combination with other laboratory assays improves diagnostic performance by delivering additional information more quickly and therefore can help guide therapeutic intervention more quickly. Recently, a new point-of-care TEG system was introduced that can run up to 4 assays simultaneously

Biosensor technologies. Electrochemical biosensor technology offers low detection limits, sensitivity, accuracy, and reproducibility and the new devices with this technology need smaller samples but provide more rapid results. Optical biosensor technology checks for hemolysis and lipemia on some optical systems and helps in measuring highly sensitive antigen-antibody reactions in proteins present in micro amounts.

DBCM technology. Dielectric blood coagulometry (DBCM) is a recently developed technology that measures changes in the dielectric permittivity of whole blood, representing clumping of red blood cells. DBCM could accurately detect the coagulation status and may offer a novel standardized assessment system for coagulation.

MSB technology. Magnetic particle spectroscopy (MSB)detects thrombus via specific binding of aptamer functionalizedmagnetic nanoparticleswith the blood clot. It uses the harmonics produced by nanoparticles in an alternatingmagnetic fieldtomeasurethe rotational freedom and, therefore, thebound stateof the nanoparticles.MSB is a promising technology to diagnose blood clots with the potential of functioning at the point of care.

Multiple-electrode aggregometry. This is an alternative assay from light transmission aggregometry that has been considered the gold standard assay but requires skilled technicians and lengthy and demanding preparation, and the results are subject to variability. Multiple-electrode aggregometryoffers shorter turnaround times and more convenient sample preparations, and measures platelet aggregation by electrical impedance.

SEER sonorheometry. A non-contact sonic estimation of elasticity via resonance (SEER)sonorheometry technology employs ultrasound to measure whole blood parameters similar to the viscoelasticity data generated in TEG and TEM. The technology measures acoustic wave forms to generate clot initiation time, clot stabilization, clot stiffness, and clotting angle. Sonorheometry is cartridge-based point of care instruments that employ small whole blood volumes and may be used to direct platelet concentrate, factor concentrate, plasma, and antifibrinloytic therapy.

Road Ahead
Automated technologies have revolutionized the monitoring of coagulation disorders in the central hospital laboratory setting, allowing for high throughput testing, improved accuracy, and precision, accompanied by a marked reduction in human error. The investigation of hemostasis has always been an important aspect of laboratory diagnostics. With the growing number of samples that a laboratory must handle, a fast, precise, and robust analyzer is essential. There are several general considerations around which the next generation of hemostasis instrumentation might be designed. Indeed, the first important issue is represented by the evolution of laboratory diagnostics as a whole.Therefore, any new analyzer should require minimal operational and maintenance time, and have a small sample and dead volume in order to analyze pediatric samples. The increasing understanding of the coagulation cascade and the interaction of various factors will lead to the development of improved and refined instruments for determination of clotting end points.

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