Assessing and monitoring the coagulation status of patients is among the highest risk areas of clinical lab testing. Testing needs vary from cardiovascular diagnosis and perioperative assessment to daily home-use testing, and are matched by users with equally varied qualifications - including patients themselves. To meet the needs of this critical care market, manufacturers of coagulation analyzers have designed and developed a variety of products matched to intended users and their settings.

Key driving factors that have fueled the uptake of coagulation analyzers are high-throughput results from hemostasis analyzers, increasing adoption of automated hemostasis instruments, and developments of high sensitivity and specificity of coagulation analyzers. High-throughput analysis, driven by multitasking of coagulation analyzers, along with advancements in point-of-care devices, is expected to boost the adoption of analyzers.

Technology Trends

Advances in coagulation analyzers. The current generation of coagulation analyzers is fully automated. Their capabilities include primary tube sampling, cap piercing, automatic rerun, and dilution. They can perform basic coagulation tests such as the prothrombin time (PT) or the activated partial thromboplastin time (aPTT) as well as more sophisticated coagulation, chromogenic, and immunologic assays using smaller sample and reagent volumes than the manual techniques.

The most common coagulation tests performed include PT, aPTT, and D- dimer. While in some labs there is a need for PT, aPTT, D-dimer, and fibrinogen; others such as (component separation) blood banks routinely perform fibrinogen and Factor VIII. Another customer set, specializing in coagulopathy, tests for certain rare parameters. However, not all available systems are equipped to cater to these requirements. The availability of small reagent pack sizes for D-dimer is also an area of interest. Point-of-care testing has gained momentum in the past few years to meet the demand for quick turnaround time, thus accelerating reliable results. D-dimer assays and POC kits have been developed to confirm the exclusion of deep vein thrombosis (DVT), pulmonary embolism (PE), and disseminated intravascular coagulation (DIC).

Point-of-care testing. When a patient receives anticoagulant medications, the values of his or her laboratory coagulation tests tell clinicians whether dose adjustments are warranted.

Techniques based on whole blood are likely to be different from laboratory measurements under conditions such as hemodilution and platelet dysfunction. The reliability of these tests depends on the experience of the operator and appropriate calibration.  Reagent sensitivity differs between manufacturers and even between two sets of reagents. These tests are expensive, needing robust systems in place for quality control and ongoing staff education. A thorough familiarity of the devices' functioning, methodology, and strengths and weakness is imperative.

Road Ahead

Traditional coagulation tests do not cover all information the clinician needs to diagnose and treat thrombophilia, hemorrhage, and inherited coagulation disorders. Global coagulation assays such as viscoelastic tests (TEM/TEG), thrombin generation tests, and clot waveform analysis care offer several advantages. While viscoelastic tests proven to be worthwhile in management of acute hemorrhage, the thrombin generation test has proven to be of use in thrombosis (venous and arterial) and even in hemostatic therapy. Clot waveform analysis is even less well known. Although there is reasonable suspicion that this method might improve diagnosis and treatment of DIC, sepsis, and hemophilia, its application is not widespread.

Technological advancements in point-of-care procedures such as outpatient anticoagulation, cardiac surgery units, and dialysis units along with quality assurance to overcome adverse reaction caused due to anticoagulation therapy and home testing services are expected to boost market growth. Additionally, lower testing volumes, improved patient care, and analyzation of more parameters are anticipated to drive demand for coagulation analyzers.

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