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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
Author(s) -
SUKHU K.,
BEAVIS J.,
BAKER P. M.,
KEELING D. M.
Publication year - 2008
Publication title -
international journal of laboratory hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.705
H-Index - 55
eISSN - 1751-553X
pISSN - 1751-5521
DOI - 10.1111/j.1751-553x.2007.00942.x
Subject(s) - d dimer , medicine , fibrinogen , venous thrombosis , venous thromboembolism , deep vein , thrombosis , gastroenterology , nuclear medicine
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 <10 min compared with 35 min for the established VIDAS ® d ‐dimer automated enzyme‐linked immunosorbent assay (ELISA, BioMerieux, Basingstoke, UK). During November and December 2005, 100 consecutive patients attending the outpatient deep venous thrombosis (DVT) clinic were tested using the VIDAS ® d ‐dimer as part of the routine DVT investigation. Using the same samples, d ‐dimer estimation was also performed on the STalia ® d ‐Di for comparison. Across a wide range of data (Vidas 83–5656) and (STalia ® <200–>4000), there was good agreement between the two methods. Using cutoff's of 500 μ g/l fibrinogen equivalent units (Keeling et al ., 1999), 42% (42/100) patients were negative (<500) and 46% (46/100) were positive (>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.