title: VIDAS D-dimer: fast quantitative ELISA for measuring D-dimer in plasma.
abstract: VIDAS D-dimer (bioMérieux) is a new quantitative ELISA for D-dimer determination designed for the VIDAS automated system. The test contains single-dose, ready-to-use reagents and is completed within 35 min. Quantitative results are obtained from a calibration curve stored in the software of the system and expressed as fibrinogen equivalent units. The two-step capture/tag test relies on two complementary monoclonal anti-D-dimer antibodies, the second one being labeled with alkaline phosphatase. The upper limit of the measuring range is 1000 micrograms/L and the lower detection limit is <50 micrograms/L, which is below the lower limit of the reference interval (68-494 micrograms/L). Reproducibility (CV) within and between runs ranges from 5% to 7%. There is no interference from heparin, bilirubin, hemoglobin, fibrinogen degradation products, or plasma turbidity. Comparison with a conventional ELISA (y) gave good correlation (r= 0.91, n= 579) and comparable results (y= 1.35x - 148, S(y/x)= 750), especially for D-dimer concentrations ranging from 0 to 1000 micrograms/L (y= 1.09x - 10.6, r= 0.88, S(y/x)= 170).
authors.affiliation: Laboratory for Hemostasis, bioMérieux, L'Etoile, France.
authors.forename: J L
authors.initials: JL
authors.lastname: Pittet
authors.forename: P
authors.initials: P
authors.lastname: de Moerloose
authors.forename: G
authors.initials: G
authors.lastname: Reber
authors.forename: C
authors.initials: C
authors.lastname: Durand
authors.forename: C
authors.initials: C
authors.lastname: Villard
authors.forename: N
authors.initials: N
authors.lastname: Piga
authors.forename: D
authors.initials: D
authors.lastname: Rolland
authors.forename: S
authors.initials: S
authors.lastname: Comby
authors.forename: G
authors.initials: G
authors.lastname: Dupuy
mesh_terms: D000469:Alkaline Phosphatase; D000818:Animals; D000911:Antibodies, Monoclonal; D000918:Antibody Specificity; D001322:Autoanalysis; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D006801:Humans; D051379:Mice; D008807:Mice, Inbred BALB C; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D000911:Antibodies, Monoclonal; D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D; D000469:Alkaline Phosphatase