DIANEONATAL® is a simple, fast, safe and reliable test for the diagnosis and monitoring of pre-eclampsia, a very common pregnancy complication that occurs in about 6-8% of all pregnancies worldwide. If not treated properly, it can develop into an eclampsia which can be fatal, therefore it is very important to diagnose a pre-eclampsia as early and reliable as possible, to protect the mother's and her unborn child's life.
Pre-eclampsia is characterized by high blood pressure and proteinuria (significant amounts of protein in the urine). In Western Europe, 5-7% of all pregnant women suffer from pre-eclampsia, about 50.000 worldwide die from pre-eclampsia every year. An early biomarker could help diagnose the condition in time and lower the risks for mother and child significantly.
Diagenics SE developed a method to measure a new biomarker for pre-eclampsia: Glycogen Phosphorylase isoenzyme BB (GPBB). This enzyme is specific for heart, brain and plazental tissue, and in case of an ischemia it is immediately released into the bloodstream - much earlier than any necrosis marker.
Currently ongoing and further studies will increase our knowledge related to the diagnosis of pre-eclampsia.
Diagenics SE owns the proprietary antibodies to this enzyme and has already developed a product line consisting of the three following DiaNeonatal® products for the early diagnosis of pre-eclampsia:
1. DIANEONATAL® POCT (Point Of Care Test) [DN - P3] is a diagnostic which measures GPBB concentration as an aid to diagnose pre-eclampsia early and reliable by the detection of GPBB in human blood or plasma. DIANEONATAL® POCT gives a solid answer on a patient‘s state shortly after symptom onset.
2. DIANEONATAL® READER: After having performed a DIANEONATAL® POCT, the respective test stripe is inserted into DIANEONATAL® Reader [DX - R1], an optical reader that analyzes the POCT within 1 minute regarding test and control line. The intensity of the test line is measured and translated into the GPBB concentration of the analyzed sample. The results are displayed, documented and stored.
3. DIANEONATAL® ELISA (Enzyme Linked Immuno Sorbent Assay) [DN-E2] is a quantitative diagnostic device for the specific and early detection of pre-eclampsia. It is a 96-well micro titer plates enzyme immunoassay (Sandwich ELISA) that is compatible with standard ELISA reader systems.
All our three DIANEONATAL® products are manufactured in the EU and have been CE registered.
For further information please study our below attached DIANEONATAL® Product Information Sheet and Diagenics Company Brochure or contact us by clicking here.