Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
Eisserer, M.
Sensitivity of the D-dimer test SimpliRED in exclusive diagnosis of deep venous thrombosis
[ Dissertation ] Medical University of Graz; 2002. pp.
- Autor*innen der Med Uni Graz:
- Betreuer*innen:
- Kerl Helmut
- Schuller-Petrovic Sanja
- Altmetrics:
- Abstract:
- Introduction: Deep venous thrombosis and subsequently pulmonary embolism are quite common diseases in the population and represent severe pathological conditions that require rapid and accurate rapid diagnostic confirmation. In this investigation we tried to verify the repeatedly praised suitability of the D-dimer test SimpliRED in the exclusive diagnosis of venous thromboembolism. Study sites and patients: In 1998, for the duration of approximately one year investigations were carried out within the meaning of a prospective documentation. Simple inclusion criterion was a suspected episode of DVT or PE. A total of 300 patients were involved referring to three dermatological centres in Austria concerning the outpatient departments of the university Hospital Graz (59 patients), the Hospital Rudolfstiftung in Vienna (181 patients) and the St. Johann Hospital in Salzburg (60 patients). Women were predominant, 200, in our examinations versus 100 men in total. Mean age was 62,71 years relating to the youngest patient of 24 and the oldest being 98 years. Each patient presenting with typical clinical symptoms, like pain, swelling or a sensation of tension and who therefore consulted the outpatient department was examined with the SimpliRED assay. In consequence duplex ultrasonography and contrast venography both regarded as the golden standards were used as reference screening procedures in order to confirm the diagnosis. Materials and Methods: The SimpliRED test is a whole blood immunoassay that allows the use of freshly collected blood, either by venipuncture of fingerstick according to the preference of the patient, was well as citrated samples. This method relies on a bi-specific antibody that is formed by the conjugation of monoclonal antibody reacting with high affinity with a site on the -chain on D-dimer, 3B6/22, with RAT-1C3/86 raised specifically against red blood cells. A whole blood D-dimer concentration of 0,2 mg/l is defined as the detection limit. SimpliRED enables the obtaining of results after only 2 minutes through the visualization of present agglutination. If any agglutination is observed, including weak and very weak one, the result is regarded to be positive and negative in case of a lack of agglutination. The overall incidence of deep venous thrombosis applying standard methods was a total of 131 patients by the indication of the presence of venous thrombi in 43,1% of the cases comparative to 56,2%, where negative results could be revealed. The sensitivity of the SimpliRED assay came out to be moderate 84,7%.