HAEMOSTASIS AND THROMBOSIS
Higher-specificity D-dimer scores in health technology assessment
Recent studies have supported a D-dimer assay role in ruling out venous thromboembolism and pulmonary embolism, linking it to health technology assessment savings, as Gillian Eyre explains.
An elevated D-dimer is now an accepted marker of a poor outcome for COVID-19 patients. Laboratory scientists played a significant part in alerting clinical colleagues on the significance of elevated D-dimer levels, not simply as a marker for the patient’s clotting risk but also the potential link between levels and outcomes. Of course, the main role for this specialist assay has always been in the investigation of patients with suspected venous thromboembolism (VTE) and pulmonary embolism (PE). Early diagnosis is crucial, with up to 60% of cases occurring during or within 90 days of a patient being in hospital.1
It is here that the question of cost
versus benefit comes to the fore – and with it, conflicting data around the performance value of current D-dimer assays. In fact, Stago is one of only two global diagnostics companies that can make an exclusion claim for both DVT and PE by completely satisfying the higher Clinical and Laboratory Standards Institute (CLSI) H59-A guidelines, which the FDA has now adopted.
A need to reduce VTE costs A cost-effective D-dimer assay that can be trusted to rule out DVT or PE early – especially where probability is low to medium – removes the need for expensive and stressful confirmatory procedures. In addition, it has a beneficial cost impact far beyond the laboratory.
As activated blood coagulation and consequent fibrinolysis are associated with increased plasma D-dimer concentration, D-dimer has become a clinically useful biomarker of thrombotic disease.
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Health technology assessments (HTA) now demand greater awareness of how decisions made in the laboratory can affect the broader care pathway. The term ‘technology’ in this context is far wider than hardware or a new drug – it refers to any method used to promote health, prevent and treat disease, and improve rehabilitation or long-term care. This can include any intervention used to treat, prevent or diagnose.
DECEMBER 2021
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