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Coagulation Instruments and Reagents

Rural India bereft of advances in coagulation

Clinical laboratories are in the throes of a technological revolution, and yet automation has not even touched the rural areas of India.

India is going through an exemplar shift as the IVD industry is expanding the span of facilities. The Indian coagulation industry is a significantly growing segment in the IVD market. Majority of the coagulation testing is performed in hospitals or attached laboratories as compared to standalone labs. When compared to the clinical chemistry segment, automation is not popular in the rural coagulation market owing to the high cost of hardware and consumables.

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.

Technology trends
In recent years, blood coagulation monitoring has become crucial to diagnosing causes of hemorrhages, developing anticoagulant drugs, assessing bleeding risk in extensive surgery procedures and dialysis, and investigating the efficacy of hemostatic therapies.

Novel anticoagulant therapies. Anticoagulants are used to treat blood clots during thromboembolic events, which do not have specific signs and consistent symptoms. For example, these agents are used to prevent and treat venous thromboembolism, for stroke prevention in atrial fibrillation, embolism prevention in heart failure, and in the management of atrial fibrillation. These new oral anticoagulants are in various phases of clinical development. Direct thrombin inhibitors (DTI) prevent thrombin activity in free plasma and at the thrombus. Lepirudin, bivalirudin, argatroban, and fondaparinux are in this category of anticoagulants. Consequently, they block conversion of fibrinogen into fibrin, decreasing thrombin generation, which affects the amplification and propagation of coagulation. On the other hand, direct factor Xa inhibitors (DFXaI) directly affect factor Xa without effects on other intrinsic/extrinsic coagulation pathways. Rivaroxaban, apixaban, edoxaban, and betrixaban are in this category of anticoagulants.

With the introduction of novel anticoagulant therapies, the validity and applicability of current coagulation measurement techniques have been in question. The new generation of anticoagulant therapies, involving dabigatran, rivaroxaban, apixaban, edoxaban, and betrixaban, were designed to minimize the requirement for monitoring or dose adjustment of the patient. However, while with these novel anticoagulants, the need for monitoring might be reduced, it will never go away for patients with special needs like kids, pregnant women, and senior people. New devices have been shown to be capable of measuring and studying effect of both types of DOACs – direct thrombin inhibitors and anti-Xa(s) – although these devices have not been employed in all clinical centers. Therefore, the applicability of already-established methods needs to be verified with these novel drugs and new methods and parameters, which will enable their monitoring will need to be established.

The manufacturers are actively pursuing novel analyzers, which more specifically assess the role of platelets in human pathologies, including bleeding and thrombotic disorders, cancer, sickle cell disease, stroke, ischemic heart disease, and others. There are several analyzers like acoustic waves that are already commercially available, and their ability to assess platelet contractile forces. These analyzers are utilized in a miniaturized point-of-care device, capable of using only a small amount of citrated whole blood, measuring the time required for fluorescent microspheres to cease motion due to clot formation. The result provided is a clotting time in seconds. Also, this system may be useful for assessing anticoagulant effects.

The ongoing novel strategies, based on microfluidics and nanotechnology, may enable potential for self-testing, self-monitoring but a great reduction in sample volume is needed. There are important mechanical parameters that relate to coagulation but are not measured, and finally they do not evaluate, monitor or mitigate acute bleeding or thrombosis risk. These drawbacks demand for the development/standardization of novel strategies that can improve the clinical diagnosis process. A continuous quest is ongoing to discover new methods of clot detection, or other novel types of coagulation analyzers are in development or will soon be ready for prime time for use in routine diagnostics of hemostasis disorders. However, these require more standardization and more clinical studies to assess and exploit their potential before they are made available in the market.

Multiplexed sensing. Electrochemical biosensors, embedded inside microfluidic chips, facilitate multiplexed sensing of different parameters like pH, oxygen, glucose, lactate, and chloride. In addition, microfluidic centrifugal technology has enabled miniaturization of typical laboratory processes such as blood plasma separation and enzyme-linked immunosorbent assay. In this regard, combining these novel platforms with microfluidic viscometers lead to the development of multiplexed microfluidic chips for blood coagulation monitoring and other blood tests. Moreover, different fluorescent probes provide monitoring of different blood coagulation factors such as thrombin and fibrin. Multiplexed sensing for both blood coagulation analysis and other biochemical parameters is promising for developing low-cost and multiplexed blood assessments.

AI in diagnosis and monitoring. With the advancements in artificial intelligence (AI) and machine learning, algorithms that can track multiple parameters simultaneously throughout a treatment/diagnosis and find out patient-specific patterns that can aid in pinpointing proper treatment or underlying causes will become one of the biggest developments in coagulation measurement technologies in the upcoming years. Especially with the challenges set by the novel anticoagulant technologies for the current measurement techniques and the validity and applicability of diagnostic parameters such as INR, simultaneous observation of multiple parameters or complicated patterns within them may be necessary for proper observation of patients with special needs. For these special cases, AI and machine learning-based algorithms may very likely find place within the future novel POC blood coagulation measurement technologies in the upcoming years.

Adopting new technologies is key
Clinical laboratories are in the midst of a technological revolution that is likely to continue during the twenty-first century. Many medical advances will be led by technological innovation in laboratory testing. New technology is positively associated with increased efficiency, reduction in errors, and improved quality in the delivery of healthcare services. Whether new technologies are implemented may depend on their impact on laboratory costs and, if they are costlier, on the payers’ willingness to pay for them.

While efforts to automate central laboratories are likely to continue, trends appear to indicate that much routine testing in the future could be delivered through PoCT and home-based testing. Centralized laboratories are likely to concentrate more on esoteric testing. Automation and shifts in the sites, where laboratory services are delivered, will result in major shifts in laboratory staffing needs. Demand for skilled IT professionals, experts to monitor and service robotic equipment, and allied health professionals is likely to grow. Overall decreases in labor costs, however, will likely lead to decreases in the cost per test.

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