ORIGINAL ARTICLES   

International Angiology 2016 December;35(6):622-8

Copyright © 2016 EDIZIONI MINERVA MEDICA

lingua: Inglese

Rapid detection of D-Dimers with mLabs® whole blood method for venous thromboembolism exclusion. Comparison with Vidas® D-Dimers assay

Grigoris T. GEROTZIAFAS ^{1, 2}, Patrick RAY ^{3, 4}, Vasiliki GKALEA ^{1, 2}, Ahlem BENZARTI ¹, Amir KHATERCHI ^{1, 2}, Claire CAST ³, Julie PERNET ³, Eleftheria LEFKOU ², Ismail ELALAMY ^{1, 2} ✉

¹ Service d’Hématologie Biologique Hôpital Tenon, Hôpitaux Universitaires Est Parisien, Assistance Publique Hôpitaux de Paris, Paris, France; ² Cancer Biology and Therapeutics, Centre de Recherche Saint-Antoine, Institut National de la Santé et de la Recherche Médicale (INSERM) U938 and Université Pierre et Marie Curie (UPMC), Sorbonne University, Paris, France; ³ Service des Urgences Hôpital Tenon, Hôpitaux Universitaires Est Parisien, Assistance Publique Hôpitaux de Paris, Paris, France; ⁴ DHU FAST, Faculté de Médecine Pierre et Marie Curie, Université Paris VI, Paris, France

BACKGROUND: Easy to use point of care assays for D-Dimers measurement in whole blood from patients with clinical suspicion of venous thromboembolism (VTE) will facilitate the diagnostic strategy in the Emergency Department (ED) setting. We prospectively evaluated the diagnostic performance of the point-of-care mLabs® Whole Blood D-Dimers test and we compared it with the Vidas® D-Dimers assay.
METHODS: As part of the diagnostic algorithm applied in patients with clinical suspicion of VTE, the VIDAS® D-Dimers Test was prescribed by the emergency physician in charge. The mLabs® Whole Blood D-Dimers Test was used on the same samples. All patients had undergone exploration with the recommended imaging techniques for VTE diagnosis.
RESULTS: Both assays were performed, on 99 emergency patients (mean age was 65 years) with clinical suspicion of VTE. In 3% of patients, VTE was documented with a reference imaging technique. The Bland and Altman test showed significant agreement between the two methods. Both assays showed equal sensitivity and negative predictive value for VTE.
CONCLUSIONS: The mLabs whole blood assay is a promising point of care method for measurement of D-Dimers and exclusion of VTE diagnosis in the emergency setting which should be validated in a larger prospective study.