Summary
Accurate and precise measurement of plasma D-dimer levels is important in the diagnosis
and management of venous thromboembolism. Considerable variability in D-dimer results
obtained using different methods has, however, been reported in multicentre studies.
This study explored in two separate multicentre exercises the degree of precision
amongst laboratory D-dimer measurements, and the degree by which inter-method agreement
could be improved using a calibration curve model. The first exercise demonstrated
generally good within-centre precision, with 82% of the centres reporting results
for two identical but differently coded samples within 10% of each other. However,
six centres reported results which would have excluded deep vein thrombosis (DVT)
for one sample but failed to exclude DVT for the other, identical sample. In the second
exercise, overall between-method precision of D-dimer results for two samples was
shown to improve markedly when a calibration model was applied, using the consensus
median values obtained by all participants for three “calibration plasmas” to recalculate
D-dimer values. For centres reporting results in fibrinogen equivalent units (FEUs),between-centre
coefficients of variation (CVs) fell from 25.9% to 11.6% and 22.4% to 7.7%, respectively,
for the two samples. For centres reporting in ng/ml, CVs fell from 45.3–21.6% and
40.8–11.6%,respectively. In conclusion, improved harmonisation of D-dimer results
by different methods may be achieved by a calibration model and common calibrant plasmas.
Keywords
D-dimer - DVT - harmonisation