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A new sensitive membrane based ELISA technique for instantaneous D.Dimer evaluation in emergency
A M Vissac1, M Grimaux, S Chartier
1Serbio Research Laboratory, Gennevilliers, France.
Thrombosis Research
|May 15, 1995
Summary
A new D-dimer ELISA test offers rapid and accurate exclusion of deep vein thrombosis and pulmonary embolism. This quick diagnostic tool helps emergency labs rule out thromboembolic events effectively.
Area of Science:
- Biochemistry
- Immunology
- Medical Diagnostics
Background:
- D-dimer is a crucial biomarker for diagnosing thromboembolic events.
- Accurate D-dimer measurement is essential for excluding deep vein thrombosis (DVT) and pulmonary embolism (PE).
- Current diagnostic thresholds require precise D-dimer quantification.
Purpose of the Study:
- To develop and validate a novel, rapid D-dimer assay for clinical use.
- To assess the assay's performance in excluding DVT and PE.
Main Methods:
- A membrane-based ELISA technique utilizing an immunofiltration device.
- Employing two complementary monoclonal antibodies for D-dimer capture and detection.
- Utilizing alkaline phosphatase for signal amplification.
Main Results:
- The assay provides results in under 10 minutes, suitable for emergency situations.
- Requires only 200 microliters of citrated plasma.
- Demonstrates clear negative results below 0.3 µg/ml and positive results above 0.5 µg/ml, with a grey zone in between.
- Achieves the required specifications for DVT and PE exclusion diagnosis.
Conclusions:
- The developed D-dimer ELISA is a rapid, accurate, and efficient tool for the exclusion diagnosis of DVT and PE.
- Its speed and minimal sample requirement make it ideal for immediate use in clinical laboratories.
- The assay meets the performance criteria for reliable thromboembolic event exclusion.