D-Dimer test meets new CLSI H59-A standards for exclusion of pulmonary embolism
Stago has received approval from the US Food and Drug Administration (FDA) for the STA-Liatest D-Di reagent for the exclusion of pulmonary embolism (PE) in patients with low or moderate risk, presenting at an emergency unit. FDA requirements for D-dimer assays for exclusion are now based on the new and more restrictive standards established and published by the Clinical Laboratory Standards Institute (CLSI, H59-A). Stago’s rapid, automated and highly sensitive D-Dimer is the first test to comply with these new requirements. In order to comply with the new CLSI guidelines, the company performed a 2-years international prospective study similar to clinical studies performed in the pharmaceutical field (9 sites, 5 countries, more than 1100 patients, including evaluation of clinical pretest probability, imaging and 3 months of follow-up), a first in the field of hemostasis diagnostics. As its coordinator Prof. Gilles Pernod (Grenoble University Hospital, France) pointed out: “As well as providing the results required to validate this test for the exclusion of PE, this study brought to light some significant evolutions in clinical practice and shifts in prevalence. In fact, these findings will be presented in some interesting upcoming publications”. This study also confirmed the excellent diagnostic performance of the STA-Liatest D-Di assay, with a very high negative predictive value (NPV) for the exclusion of PE, far exceeding FDA requirements (>99.7% versus 97%), and excellent sensitivity (>97% versus 95%). The second part of this international clinical study, concerning deep vein thrombosis (DVT), is underway and due to be completed in the next few months.
