Stago's D-dimer test meets the new CLSI H59-A standards for exclusion of pulmonary embolism

Sept. 19, 2014

Stago has received approval from the U.S. Food and Drug Administration (FDA) for the reagent STA -Liatest D-Di, in 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 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 complies with these new requirements.

In order to comply with the new CLSI guidelines, Stago performed a two-year, international, prospective study, similar to clinical studies performed in the pharmaceutical field (nine sites; five countries; more than 1,100 patients; including evaluation of clinical pretest probability, imaging, and three months of follow-up).

As the study’s coordinator, Gilles Pernod, MD, PhD, of Grenoble University Hospital, France, points out, “As well as providing the results required to validate this test for the exclusion of PE, this study brought to light a significant evolution of clinical practices and shifts in prevalence. In fact, these results 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, 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 is due to be completed in the next few months. Read more about the study on a National Institutes of Health (NIH) website.

Read more