New Diagnostic Tool to Aid the Diagnosis of Early Onset Pre-Eclampsia

The Alere Triage® PLGF test is a new diagnostic tool as an aid to the diagnosis of early onset pre-eclampsia. Currently, the condition is diagnosed by an increase in blood pressure and presence of protein in the urine, but these signs are non-specific for pre-eclampsia and are not always present in women who develop severe complications.

This new tool uses the measurement of Placental Growth Factor (PlGF), a biomarker involved in placental development. This provides a highly sensitive and specific indication of the placental dysfunction which leads to early onset pre-eclampsia.

The new Alere Triage® PLGF test, for use with the Alere Triage® MeterPro, can aid clinicians in the diagnosis of early onset pre-eclampsia by measuring the level of PlGF in a plasma sample. A low PlGF measurement alerts the clinician to the high probability of pre-eclampsia. PlGF is made by the placenta and encourages blood vessel growth. PlGF circulates at high concentrations in normal pregnancy, with levels peaking at 32 weeks and decreasing towards full term. However, the concentration of PlGF is significantly decreased in women with early onset pre-eclampsia.

“No complication of human pregnancy is both so common and so dangerous for both mother and baby as pre-eclampsia. Yet its detection is fraught with uncertainties leading to over management for many expectant mothers while others have serious problems that go undetected. A reliable diagnostic blood test, such as the Alere Triage® PLGF, which potentially can be used close to the mother without the need for elaborate equipment or trained laboratory staff, is a major step forward for both pregnant women and those who look after them” comments Professor Christopher Redman, Emeritus Professor of Obstetrics, Oxford, UK.

Identifying early onset pre-eclampsia is important because the condition can escalate into dangerous crises. Women with early onset pre-eclampsia must be closely monitored to ensure the pregnancy is ended by delivery before the onset of serious complications. Pre-eclampsia is a cause of maternal deaths during pregnancy1 and can lead to foetal growth restriction, low birth weight, prematurity-associated respiratory distress syndrome and is an important risk factor in stillbirth. By accurately identifying which women have placental dysfunction, healthcare resources can be applied to the women at greatest risk of complications.

After separating plasma from an EDTA whole blood sample the Alere Triage® MeterPro System provides rapid and accurate quantification of PlGF plasma. The test can be performed in a laboratory or clinic setting and provides results within 15 minutes.

The Alere Triage® PLGF test is CE marked, which expresses conformity with the requirements of the European IVD Directive and will initially be launched throughout Europe and in Australia. A timeline for US and the rest of the world availability will be established shortly.