The reality of laboratory diagnostics and coagulation testing is evolving with new paradigms of efficiency. Laboratory diagnostics is undergoing a substantial reorganization, with emergence of new models under the imperative of terms, such as bedside testing, consolidation, and networking. The paradigms under which these changes are being developed include a variety of environment, pre-analytical,
technological, professional, and healthcare aspects. The maintenance of continued quality is indeed the major challenge to be faced in the foreseeable future. In fact, some challenges pre-potently emerge during a consolidation process, which basically involve delayed testing, centrifugation, transportation, and stability of the specimens, as well as the potential mismatch of the sample matrix.

Global Market

The global coagulation analyzers market is expected to reach USD 3.58 billion by 2019 from USD 2.6 billion in 2015, growing at a CAGR of 8.3 percent from 2015 to 2019.

In product type, clinical laboratory segment accounted for the largest share in 2015. In clinical laboratory segment, the consumables segment accounted for the largest share in 2015. Also, this segment is expected to grow at the highest CAGR over the next four years. Various factors such as growing adoption of advanced hemostasis instruments and growing demand from emerging countries are driving the growth of this market.

A number of factors such as the development of high-throughput coagulation analyzers, increasing adoption of automated hemostasis instruments by diagnostic laboratories, technological advancements, and developments in high-sensitivity point-of-care (POC) hemostasis testing are propelling the growth of the global coagulation analyzers market. On the other hand, slow adoption of advanced hemostasis instruments in emerging economies and high cost of coagulation analyzers are restricting the growth of the global coagulation analyzers market.

Based on geography, the global coagulation analyzers market is dominated by North America, followed by Europe, Asia-Pacific, and the rest of the world (RoW). North America accounted for the largest share of the market in 2015, while Asia-Pacific witnessed the highest growth in this market. A number of factors, including developing healthcare infrastructure, presence of a large patient population, increasing funding/investments toward the development of hemostasis products, and growing focus of both international and domestic players on emerging Asia-Pacific countries are stimulating the growth of the coagulation analyzers and reagents market in this region.

Technology Trends

Automation is now commonplace in several areas of diagnostic testing; especially in clinical chemistry and immunochemistry, the concept of extending this process to hemostasis testing has only recently been advanced. The leading drawbacks are still represented by the almost unique biological matrix because citrated plasma can only be used for clotting assays and few other notable exceptions, and by the highly specific pretreatment of samples, which is particularly distinct to other test systems. Despite these important limitations, a certain degree of automation is also now embracing hemostasis testing.

More relevant developments include the growing integration of routine coagulation analyzers with track line systems and work cells, the development of specific instrumentation tools to enhance reliability of testing (i.e., signal detection with different technologies to increase test panels, plasma indices for pre-analytical check of interfering substances, failure pattern sensors for identifying insufficient volume, clots or bubbles, cap-piercing for enhancing operator safety, automatic reflex testing, automatic redilution of samples, and laser barcode readers), pre-analytical features (e.g., positive identification, automatic systems for tube(s) labeling, trans-illumination devices), and post-phlebotomy tools (pneumatic tube systems for reducing turnaround time, sample transport boxes for ensuring stability of specimens, monitoring systems for identifying unsuitable conditions of transport).

Regardless of these important innovations, coagulation testing still requires specific technical and clinical expertise, not only in terms of measurement procedures but also for interpreting and then appropriately utilizing the derived information. Thus, additional and special caution has to be used when designing projects of automation that include coagulation testing because peculiar and particular requirements must be taken into account.

Automation and Patient Care

Providing quality patient care will continue to be the driving force behind the future of clinical automation. A well-implemented automation system helps achieve better turnaround times, resulting in faster diagnosis. Patients are treated more quickly and hospital stays are shortened. There is still a lot of untraveled territory in automation, as many labs still have to implement it.

Automation is not only for high-volume customers; all labs, no matter the size, can benefit from automation features, as automation systems are scalable. Systems will begin to have more multidisciplinary features and incorporate deeper connectivity among the analyzers. One will likely see further reduction in turnaround time, the ability to capture more errors earlier, and advanced flexibility for all types of labs.

The future of automation is driven by the need to do more with less, as lab budgets are reduced and staffing shortages increase. In order to better allocate skilled resources in the lab, automation systems will be able to more efficiently handle the tedious, and sometimes hazardous, tasks while skilled laboratory professionals are able to focus on important matters that require human interaction. The knowledge that they are performing more important tasks will increase these professionals' job satisfaction and quality of work, and help labs to retain them. The ultimate goal will be achieved and performance in the lab will increase.

Dr Vanajakshi S, HOD and Senior Consultant, Department of Hematology and Clinical Pathology, Apollo Health City, Hyderabad
Second Opinion
Laboratory Control of Anticoagulant Therapy

For the most part, cardiovascular disorders - heart attack and stroke - are linked to circulatory diseases, which account for at least 15 million deaths every year. Many more are disabled by them. The cost of caring for patients with circulatory diseases accounts for about 
10 percent of direct healthcare cost in developed 
countries.

Prevention and treatment of cardiovascular diseases have improved as a result of new guidelines for oral anticoagulants set by WHO. These drugs cannot be prescribed at a fixed dose. For each patient, the dose must be adjusted according to the result of a vitally important blood clotting test - Prothrombin time test - to be conducted every four weeks to maintain the therapeutic range. If the dose is low, the patient is at risk of developing thrombosis. If the dose is high, there is a risk of spontaneous bleeding.

Standardization of oral anticoagulant therapy comprises the following steps:

  • A thromboplastin is chosen and its international sensitivity index (ISI) is determined by comparison with a reference thromboplastin.
  • The geometric mean normal PT (GMNPT) is determined for that thromboplastin.
  • PTs are performed on patient samples and the results are converted to an international normalized ratio (INR).
  • Reference thromboplastins of rabbit and bovine are available as WHO reference preparations, from the Institute for Reference Materials & Measurements or Certified Reference Materials from commercial suppliers.

    Dr Vanajakshi S
    HOD and Senior Consultant,
    Department of Hematology and Clinical Pathology,
    Apollo Health City, Hyderabad


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