The evolution of coagulation testing: Trends, challenges, and opportunities

Bleeding disorders affect a patient’s blood's ability to clot correctly. Such conditions include hemophilia, von Willebrand disease, and factor deficiencies.¹ Due to the variability of clinical symptoms, delayed diagnosis is common for these illnesses.¹

Coagulation testing provides clinicians with important insights into how well a patient’s blood clots. These tests play a critical role in diagnosing the above-mentioned bleeding disorders, monitoring treatment response to medications, and identifying patients with potential risks for bleeding following surgeries.²

For the last several years, coagulation testing has evolved from manual techniques to more sophisticated systems. Key milestones include automation, advanced biomarker assays, digital connectivity solutions, and point-of-care options that have significantly improved the efficiency and accuracy of coagulation tests.³

With the ever-increasing complexity of diagnostic testing, there is a growing demand for quicker, more accurate results. Coagulation labs experience numerous challenges, many of which can be attributed to lack of staff training, the time required for manual tasks, and risks associated with manual errors/improper handling.

For example, resource management can be an issue due to high reagent and maintenance costs. Labs with high-volume demand struggle to balance equipment and instrument costs with maximal efficiency and resource utilization.⁴

Another challenge is workforce training and the time required for manual tasks in coagulation labs. Additionally, some instruments demand specialized skills or troubleshooting expertise. Overall, manual processing carries risks, as improper sample handling can compromise integrity, leading to errors and inaccurate test results.^4,5

Regulatory compliance and standardization also remain a barrier to providing reliable diagnostic testing results. Standardized collection protocols and quality control measures, which can be challenging to account for when using manual processes, are essential, especially with the evolving accreditation requirements.⁶

To help address these challenges and improve coagulation testing, coagulation facilities can adopt innovative technologies, including automated workflows, predictive analytics, and AI-driven insights. Each of these technologies offers a solution to address the tedious, error-prone manual procedures within the clinical lab.

Automated reagent handling technologies enable labs to analyze higher sample volumes compared to manual processes. This approach not only reduces errors but also allows personnel to conduct more important tasks. These automated processes also enhance data integration with laboratory information systems (LIS) and help improve operational efficiency by decreasing turnaround time and identifying errors. Additionally, instruments with random access and walk-away features provide around-the-clock high-throughput testing.^3,7,8

AI-driven tools and machine learning algorithms can enhance data interpretation, identify trends, and predict thrombotic risks based on coagulation tests.³ For example, AI can assist in analyzing historical levels of D-dimer, a protein fragment released when blood clots break down, to assess the likelihood of recurrent thrombosis.⁹ Such enhancements help clinicians make faster and more informed decisions, especially in critical conditions like thrombosis management or anticoagulation therapy adjustments.

Lastly, point of care coagulation testing has revolutionized bedside and in-home testing for quick assessment of hemostasis, another important opportunity that healthcare systems can leverage to affect patient outcomes. These advanced, easy-to-use instruments allow remote monitoring and treatment management providing actionable results within minutes.³

It is important for lab leaders to stay ahead of these innovative technologies in coagulation testing to account for growing healthcare demands and impact patient outcomes. However, before implementing any advanced solutions, lab leaders need to ensure that these technologies can be seamlessly integrated into the current infrastructure, both within the existing lab setup and within the broader healthcare system.

Advanced molecular diagnostics have enabled specialized testing like improved von Willebrand testing and correlation analysis, collagen binding assays, and platelet function analysis. This approach has increased diagnostic capabilities and revolutionized the global management of coagulation disorders.^1,3

As seen during the COVID-19 pandemic, there is a significant clinical need for robust screening and diagnostics, especially at the point of care.^2,3 Lab leaders need to stay at the forefront of innovation to help their health systems accelerate the diagnosis of coagulation disorders and provide more effective response monitoring of anticoagulant therapy. To remain informed on next-generation coagulation testing solutions, it is important to collaborate with industry experts to understand how novel technologies can enhance diagnostic accuracy and impact patient care.