Utrecht University Medical Centre, Jeroen Bosch Hospital and Star-shl have tested, in a laboratory setting, the analytical performance and user-friendliness of five new D-dimer POC tests on blood samples from 250 patients with suspected DVT/PE: the EVA study. The results were very good. This study is now being followed up by investigating whether the test also works well with a drop of whole blood and outside the central laboratory: the EVA 2 study.
The Dutch (NHG) guideline Deep Venous Thrombosis and Pulmonary Embolism (DVT and PE) recommends a D-dimer POCT test if, based on a clinical decision rule, the probability of the condition is estimated to be low. In this way, DVT and PE can be safely excluded, preventing the patient from having to visit a hospital for unnecessary additional examinations. The recommended (simple) qualitative card test, however, was taken off the market 3 years ago after concerns about its reliability and user-friendliness.
The five tested, quantitative D-dimer tests five different POCT analysers scored very well when the test results with blood plasma from patients with and without the disease were compared to the (routine) reference method at the central laboratory.
The final step that we are now taking is a scientific comparison of testing with whole blood versus plasma. Star-shl’s diagnostic centre on St. Ignatiusstraat in Breda is one of (currently) three participating centres. Leeuwarden Medical Centre and Antonius Hospital in Sneek are the other two participating centres. If this follow-up study also works out well, we will be able to make a choice as to which instrument is most suitable for use in general practice. Meanwhile, we expect new D-dimer POCT methods on the market in the coming year that will also use whole blood from a finger prick. Star-shl is following these developments and, of course, will remain in frequent contact with these (new) international POCT suppliers.
The Jan Schueler Foundation is supporting this initiative on the basis of its objective to make new laboratory diagnostics available for primary care.