Reliability of Five Rapid D-Dimer Assays Compared to ELISA in the Exclusion of Deep Venous Thrombosis

Summary

Studies measuring the fibrin degradation product D-Dimer (DD) using enzyme-linked immunosorbent assays (ELISA) in patients with venographically proven deep venous thrombosis (DVT) suggest that it is possible to exclude DVT when DD level is below a certain cut-off level. However, ELISA methods are time-consuming and not available in all laboratories. Different rapid latex-agglutination assays have been investigated, but their sensitivity is considerably lower.

In the present study we compared the value of four novel latex DD tests (Tinaquant^®, Minutex^®, Ortho^® and SimpliRed^®) and one rapid ELISA (VIDAS^®) to a classical ELISA DD assay (Organon Mab Y18^®) in 132 patients suspected of DVT.

The VIDAS^®, a new quantitative automated ELISA, had a sensitivity of 100% and a negative predictive value of 100% for both proximal and distal DVT at a cut-off level of 500 ng/ml. The Tinaquant^® assay, a new quantitative latex method, had a sensitivity of 99% and a negative predictive value of 93% for both proximal and distal DVT at a cut-off level of 500 ng/ml. For proximal DVT only, both assays had a sensitivity and negative predictive value of 100%. VIDAS^® and Tinaquant^® correlated well with ELISA (correlation of r = 0.96 and r = 0.98 respectively). Sensitivities of the semi-quantitative latex assays Minutex^®, Ortho^® and SimpliRed^® were considerably lower (77%, 51 % and 61 % respectively).

These results suggest that VIDAS^® and Tinaquant^® may be used instead of ELISA DD in the exclusion of DVT. Tinaquant^® can be performed within 20 min and VIDAS^® within 35 min. Both assays might be used as a routine screening test and should be evaluated in large clinical management studies.

• References

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