Rapid test (point-of-care test) Preeclampsia

Dianeonatal POCT [DN – P3] is an in vitro diagnostic for specific and early diagnosis of preeclampsia for the detection of GPBB in human blood or plasma.
A point-of-care test (POCT) for early and reliable proof of preeclampsia, based on the marker glycogen phosphorylase BB (GPBB).
Dianeonatal POCT provides qualitative proof enzyme GPBB, which is due to placental ischemia released into the blood. By using whole blood or plasma, Dianeonatal provides solid information about the condition of a patient shortly after the first occurrence of the Symptoms.
As a lateral flow test, the enzyme immunoassay provides reliable results within 15 minutes.
Registration time: Q4/2014
The CE-certified production partner of The Dianeonatal POCT Systems is VEDA. LAB, France.

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The point-of-care test (POCT) is used in emergency medicine as a fast and qualitative test for a therapy decision-making basis. Point-of-care tests are beneficial because of their quick results and diagnosis can be made immediately without the help of a laboratory or an existing diagnosis is supported by the test result. The DIANEONATAL® POCT is a strip test that works on the basis of GPBB as a biomarker for present preeclampsia.

The monoclonal catch antibody for GPBB is applied in narrow traces on the multi-layer strip. Another antibody (detect antibody) is applied to the strip with a special buffer solution after the drop of blood. This antibody is coupled with an enzyme that causes the color change. If the blood sample runs along the absorbent strip onto the antibody track, GPBB is bound by catch antibodies and made visible by the enzyme reaction.

As little 50 ul, a droplet of maternal blood, is enough to take a solid measurement. The test time for the quick test is only 15 minutes. Although less well known in the population, preeclampsia is a common pregnancy complication (6-8% of all pregnancies in the West, up to 50% in other regions, particularly in Africa and Asia, are affected), which in any case requires monitoring and treatment at a very high risk to the baby and mother. The only effective treatment today is the induction of premature birth, whereby the doctor always has to weigh up the risk for the mother and the baby; here a biochemical marker is a very important addition to the treatment decision.

Initial studies have shown that GPBB levels are significantly increased in the blood of expectant mothers with preeclampsia. The aim of DIAGENICS is to establish DIANEONATAL® as a standard for diagnosing preeclampsia and monitoring the affected pregnant women.

A large multinational study is currently underway to verify GPBB as a marker for preeclampsia. The DIANEONATAL® POCT is simple, fast, safe and reliable. The marketing of the product is initiated worldwide.


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