Comparison of an immuno-turbidometric method (STalia D-DI) with an established enzyme linked fluorescent assay (VIDAS) D-dimer for the exclusion of venous thromboembolism.
2008
Summary
The use of d-dimer tests for the exclusion of venous thromboembolism is an important advance in clinical practice and also has economic benefits. The Stalia®d-Di (Diagnostica Stago, Asnieres, France) is a semi automated system for the quantification of d-dimer using an immuno-turbidometric method incorporating a suspension of latex microparticles coated with two different monoclonal antibodies specifically targeted against human d-dimer fragments. Results are available rapidly in 4000), there was good agreement between the two methods. Using cutoff's of 500 μg/l fibrinogen equivalent units (Keeling et al., 1999), 42% (42/100) patients were negative ( 500) on both systems. Six per cent (6/100) were positive on the Vidas but negative on the STalia® and another 6% (6/100) were positive on the STalia® but negative on the Vidas. In conclusion, 88% (88/100) of patients showed agreement and in the other 12% (12/100), one had a DVT as identified by Compression ultrasonography (CUS). In this study, there were seven patients with a DVT as identified by CUS and they all scored as ‘likely’ on a pretest clinical probability score and so negative d-dimer would not be used clinically to rule out the disease. The Vidas is a well established instrument for d-dimer measurement in outpatient DVT clinics, and in this small study the STalia® compares very well and therefore would fit into an outpatient setting for d-dimer measurement. But ideally a larger study would be required before implementing new methodology in a clinical setting.
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