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.
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