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VIDAS D-dimer: fast quantitative ELISA for measuring D-dimer in plasma
J L Pittet1, P de Moerloose, G Reber
1Laboratory for Hemostasis, bioMérieux, L'Etoile, France.
Clinical Chemistry
|March 1, 1996
Summary
The VIDAS D-dimer assay offers a rapid, quantitative ELISA test for D-dimer determination. This automated system provides reliable results within 35 minutes, aiding in clinical diagnostics.
Area of Science:
- Clinical Chemistry
- Immunodiagnostics
- Biotechnology
Background:
- D-dimer is a critical biomarker for thrombotic events.
- Accurate and rapid D-dimer quantification is essential for clinical decision-making.
- Existing methods may require longer turnaround times or complex procedures.
Purpose of the Study:
- To evaluate the performance of the new VIDAS D-dimer assay.
- To assess its suitability for routine clinical use on the VIDAS automated system.
- To compare its accuracy and reproducibility against a conventional ELISA method.
Main Methods:
- The study utilized the VIDAS D-dimer assay, a quantitative enzyme-linked immunosorbent assay (ELISA).
- The assay employs a two-step capture/tag method with monoclonal anti-D-dimer antibodies.
- Results were obtained using a pre-calibrated automated system and compared to a conventional ELISA.
Main Results:
- The VIDAS D-dimer assay demonstrated high reproducibility (CV 5-7%) and a wide measuring range (up to 1000 µg/L).
- The assay showed excellent correlation (r=0.91) and comparable results to a conventional ELISA, particularly in the clinically relevant range.
- No significant interference was observed from common interfering substances like heparin or bilirubin.
Conclusions:
- The VIDAS D-dimer assay is a reliable, automated, and rapid method for D-dimer quantification.
- Its performance characteristics make it suitable for routine clinical laboratory use.
- The assay offers a valuable tool for the diagnosis and management of thrombotic disorders.