Olympus Life And Material Science Europa - diagnostics, has announced the launch of a D-Dimer immunoturbimetric assay for use on its AU family of clinical chemistry systems
D-Dimer continues to grow in importance as a frontline assay for early rule-out of both venous thromboembolism (VTE) conditions - deep vein thrombosis (DVT) - and pulmonary embolism (PE).
The need for D-Dimer testing is increasingly clear - according to the American Heart Association, DVT blood clots alone affect some two million and complications kill up to 200,000 people annually in the USA, with similar figures in Europe.
However there are currently few assays available for fully-automated analyser platforms.
The new Olympus D-Dimer assay has been developed by the Olympus in-house R+D team to ensure full compatibility across the AU family of medium to ultra-high throughput clinical chemistry systems.
According to product manager Peter Rene Hesse, the new assay meets the special challenges of VTE testing: "Since D-Dimer is used as a rule-out assay, clinical sensitivity is of paramount importance along with negative predictive value (NPV).
"Due to a lack of an international reference standard, Olympus employs the commonly used and accepted cut-off value of 0.5ug FEU/ml, which means that customers do not need to change EQA data.
"With results in less than ten minutes, we are confident that the Olympus D-Dimer assay will make a real contribution to front line testing for this devastating and potentially fatal condition."