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).

The D‐dimer assay

“…Each of these test methods has its own specific considerations and limitations, which has been thoroughly reviewed elsewhere . The Vidas D‐dimer assay, a widely used method, reportedly shows no interference from heparin, bilirubin, hemoglobin, fibrin degradation products, or plasma turbidity . Tables and provide a summary of specific D‐dimer assays that have been frequently used in clinical trials for VTE exclusion, including their respective cutoff values, sensitivities, and specificities.…”

Validation, Calibration, and Specificity of Quantitative D-Dimer Assays

“…An automated ELISA using fluorescent detection has been developed for the VIDAS analyzer (bioMérieux, Marcy L'Etoile, France). 59 Membrane-based immunoassays are rapid, do not require expensive laboratory instruments, and provide semiquantitative or quantitative results if reflectometric optical detection systems are used. Assays include one semiquantitative ELISA, 60 one quantitative assay using immunogold-labeled antibodies, 61 both using plasma as sample material, and one quantitative assay using either plasma or whole blood.…”

Sensitive label-free electron chemical capacitive signal transduction for D-dimer electroanalysis

“…Then, by means of several technological advances, automatic Enzyme-Linked Immunosorbent Assays (ELISA) became the most common analytical way of measuring DD [8]. ELISA-based analytical methodologies for DD are indeed quite sensitive and reliable (Limit of detection [10] of 45 mg L À1 ), but on the other hand they can be time-consuming and cannot be performed as a bedside assay. Nowadays, the combination of antibody-based sensors (immunosensors) with electrochemical detection has proven to be a successful strategy in the development of a novel generation of DD biosensors [11].…”