Analytical characteristics assessment of an Elisa for plasmatic GDF-15 quantification

Background. - Growth differentiation factor-15 (GDF-15) is a member of the transforming growth factor-beta. (TGF beta) superfamily. The growing interest for its prognostic value in acute coronary syndromes (ACS) and pulmonary embolism lead us to evaluate a recently commercialised immunoenzymatic Elisa kit. Methods. - The DuoSet (R) Elisa kit (RED Systems (R)) was evaluated according to the Societe francaise de biologie clinique (SFBC) validation protocol. Pre-analytical conditions were tested. GDF-15 was quantified in two groups: "healthy" individuals and patients with troponin greater than 0,15 mu g/L. Results. - The method was validated. Heparinated plasma at a one-eighth dilution was selected for the study. The stability of GDF-15 allows several freeze/thaw cycles. Medians of the GDF-15 levels in the two populations (827 ng/L versus 3268 ng/L) were significantly different. Conclusion. - The DuoSet (R) Elisa kit can be used to quantify GDF-15 in human serum and plasma. This will allow us to study GDF-15 prognostic interest in different clinical settings like ACS and pulmonary embolism. (C) 2010 Elsevier Masson SAS. All rights reserved.