Prediction of risk for Type 2 Diabetes development.
BelDIA PRE is an easy to use screening test device for patients, clinics and physians. By determination of fasting plasma concentration of intact proinsulin, the test describes development of type 2 diabetes mellitus even up to one years prior to glucose elevation. It is designed as a point-of-care device to provide immediate results.
The early test is working with a lateral-flow based technology similar to a pregnancy test. The result is provided in a qualitative way and is either “positive” or “negative”. One drop of blood capillary blood (10 µl) is needed, e.g. obtained by pricking the fingertip.
BelDIA PRE is a risk screening test for the measurement of Intact Proinsulin in human capillary blood by means of a lateral-flow based technology, for rapid determination of a failure of the pancreatic ß-cells, which is associated with the development or prevalence of Type 2 diabetes mellitus or its macro vascular complications.
The test uses the established cut-off reference range of intact proinsulin to differentiate physiological from pathological results. In case of a positive result, the patient is advised to visit his doctor to seek for recommendations for measures to prevent or delay disease manifestation (e.g. lifestyle recommendations) or to undergo further diagnostic procedures to confirm the disease stage (e.g. oral glucose challenge test).