Our understanding of the basic science and clinical issues surrounding hemostasis has tremendously increased in the last decade or so. To list a few: (1) we have established better treatment for patients at risk for hemorrhage or thrombosis; (2) identified new hereditary coagulation disorders; and (3) provided mechanism(s) for clinical hemostatic diseases. With this in mind, clinicians have begun to put more demand on the coagulation laboratory. The laboratory has had to keep pace by developing new coagulation tests, and better standardizing those tests already in use. The cornerstones of clinical coagulation testing are the prothrombin time and/or international normalized ratio (PT/INR) and the activated partial thromboplastin time (aPTT) for identifying and monitoring clinical coagulation disorders and therapeutics.
Manufacturers have also varied the sensitivities of the reagents to more easily assess the variety of clinical conditions. It now has become important for each laboratory to evaluate the commercial reagents to determine the most appropriate one for their clinical needs. The criteria for how reagents should be evaluated include: sensitivity for intended use, compatibility with instrumentation, number of assays performed each day, and cost.
Blood coagulation or clotting is the process by which blood changes from liquid to gel, thus, forming clots. These clots result in cessation of bleeding. Hemostasis involves a coordinated series of interactions between platelets and numerous blood-clotting proteins. With increasing prevalence of hemostatic diseases, the demand for blood-coagulation testing has increased.
Moreover, advancing technology in blood-coagulation testing is adding fuel to the growth of the market. Furthermore, increasing prevalence of liver disease, thrombophilia, and hemophilia also drives the market growth. However, availability of expensive treatment and poor reimbursement policies in the developing regions of the world are some of the challenges, which restrict the market growth. The global blood-coagulation testing market is expected to grow at a CAGR of 6.5 percent during the forecast period 2017–2023. The global blood-coagulation market is segmented on the basis of: product – segmented into clinical laboratory, automated testing, and semi-automated testing; application – segmented into congenital bleeding disorders, acquired bleeding disorders, Von Willebrand disease, and hemophilia; test type – segmented into various testing kits; and others. Furthermore, testing kits are segmented into prothrombin time (PT), activated clotting time, D dimer, and fibrinogen (FIB). On the basis of the end user, the market is segmented into academic institutions, hospitals, and diagnostic laboratories.
Although laboratory determination of PT/INR remains the gold standard of reference in instances of an unexpected patient result, POC PT/INR measurement offers significant advantages as a decision and management tool, both in and out of the hospital. In the emergency room, in the coronary care unit, in surgery, and in procedure suites when time is paramount, POC PT/INR analyzers provide immediate, actionable results. These devices also can help expedite patient management in a range of settings as diverse as outpatient clinics, physicians’ offices and surgeries, pharmacies, care centers, and patients’ homes.
Recently, new technologies have been introduced: luminescent oxygen-channeling immunoassay (LOCI), magnetic sensor-based point-of-care (POC) coagulation testing, microfluidic strip-based POC, microresonator-based on microelectromechanical systems (MEMS) technologies, and electrochemical sensor-based coagulation testing. Along with these in-vitro techniques, Campbell et al. have introduced laser scanning confocal microscopy (LSCM) to observe in situ thrombin generation. Other in vivo studies of thrombin have introduced microenzyme immunoassay to measure thrombin-anti-thrombin complex (TATc) levels. Advanced research has seen an inclination toward coagulation tests with POC, primarily focused on improved system miniaturization and functional integration. But POC technologies are facing challenges, which include the quality, robustness, cost, intellectual property issues, regulatory approval, clinical acceptance, economics of test usage, and the ultimate market size.