title: Validation of STA-Liatest D-Di assay for exclusion of pulmonary embolism according to the latest Clinical and Laboratory Standard Institute/Food and Drug Administration guideline. Results of a multicenter management study.
abstract: : Combined clinical pretest probability (PTP) and D-dimer testing have great diagnostic value for pulmonary embolism exclusion. To harmonize performance levels of D-dimer assays available on the market, the Clinical and Laboratory Standard Institute (CLSI) has published a guideline, endorsed by the US Food and Drug Administration (FDA). Such guideline specifies the ideal D-dimer assay characteristic and target population. This study was conducted following the CLSI guideline to upgrade the assay-intended use and obtain FDA clearance of STA-Liatest D-Di assay for pulmonary embolism exclusion in patient with low/moderate PTP. This was an international, multicenter, prospective nonrandomized, noninterventional clinical outcome management study conducted in a standard of care setting. D-dimer assay was performed in consecutive, ambulatory outpatients suspected of pulmonary embolism, with low/moderate PTP, and without medical conditions or in clinical settings known to alter default D-dimer values regardless of the presence of thrombosis using a threshold of 0.5 μg/ml (fibrinogen equivalent units) for venous thromboembolism exclusion. Results were used to determine test performance. Of 1141 patients who underwent D-dimer testing, 1060 had valid results and completed study as planned. STA-Liatest D-Di assay performance has exceeded the CLSI/FDA guidance requirements, with a sensitivity of 97.6% (95% confidence interval: 91.7-99.7%) and a negative predictive value of 99.7% (95% confidence interval: 99.0-100%). STA-Liatest D-Di assay has an excellent performance when used in combination with a PTP score in relevant patients and has the potential to minimize the economic healthcare burden avoiding unnecessary and expensive imaging tests.
authors.affiliation: aDepartment of Vascular Medicine, Grenoble University Hospital, Grenoble, France bPathology and Laboratory Medicine, Ohio State University, Columbus, Ohio, USA cHematology Laboratory, University Hospital, Dijon, France dPathology and Laboratory Medicine, Medical University South Carolina, Charleston, South Carolina, USA eDepartment of Haematology, Hôpital Maisonneuve-Rosemont, University of Montreal, Montreal, Canada fDepartment of Haematology, Santa Barbara General Hospital, Soria gLaboratio de Coagulación, Centro Sanitario Hospital General Universitario de Alicante, Alicante, Spain hDepartment of Angiology and Blood Coagulation 'Marino Golinelli', Bologna University Hospital Corporation, Policlinica S. Orsola Malpighi, Bologna iCoagulation Service and Thrombosis Research Unit, Scientific Institute San Raffaele, Milano, Italy.
authors.forename: Gilles
authors.initials: G
authors.lastname: Pernod
authors.forename: Haifeng
authors.initials: H
authors.lastname: Wu
authors.forename: Emmanuel
authors.initials: E
authors.lastname: de Maistre
authors.forename: John
authors.initials: J
authors.lastname: Lazarchick
authors.forename: Jeannine
authors.initials: J
authors.lastname: Kassis
authors.forename: Carlos
authors.initials: C
authors.lastname: Aguilar
authors.forename: Pascual M
authors.initials: PM
authors.lastname: Vera
authors.forename: Gualtiero
authors.initials: G
authors.lastname: Palareti
authors.forename: Armando
authors.initials: A
authors.lastname: D'Angelo
mesh_terms: D001681:Biological Assay / Q000379:methods*; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000378:metabolism*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000175:diagnosis*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D