A new simple blood test shows promise for improving diagnosis and clinical management of pre-eclamp


An editorial published this week in the Lancet online1 highlights the shocking fact that many maternal deaths in the UK are associated with substandard care and are potentially preventable. According to the latest report of Confidential Enquires into Maternal Deaths in the UK (the CMACE report2), the most common reason for maternal death resulting from substandard care was a failure to diagnose or appropriately manage pre-eclampsia.

Pre-eclampsia is a multisystem disorder that affects about 2-8% of all pregnancies1.  Due to the non-specificity of signs and symptoms, it remains a serious clinical challenge that presents significant risks to both mother and child. There is no other pregnancy complication that is both so common and dangerous for mother and child alike, since it can lead to maternal death, stillbirth and preterm delivery.

According to the Lancet editorial, the contributing experts state that “deaths from pre-eclampsia should be exceptional, without substandard care, and not a leading cause of maternal mortality.” They call further attention to the fact that pre-eclampsia is unpredictable in its presentation and speed of progression.

For these reasons, there is a need for improved blood markers that can reliably and quickly identify women with pre-eclampsia. Better knowledge of the disease’s origin3 has led to the development of a simple blood test that detects a hormone, Placental Growth Factor (PlGF), which is produced by the placenta and falls to very low levels in women with the early onset and severe forms of pre-eclampsia.

A newly published international study has confirmed that PlGF can be reliably and quickly measured within 15 minutes using the Alere Triage® System. 4 This evaluation found that the Alere Triage® PLGF Test performed well in comparison to diagnoses made by Consultant Obstetric Clinicians involved in academic research in this area. It also established this new test for early onset pre-eclampsia as having a high clinical sensitivity and supported its reliability in identifying the disease.

“Triage® PLGF has the potential to remove the uncertainty in clinical decision-making at the point of care, without delay, in women presenting with signs and symptoms of pre-eclampsia before 35 weeks,” noted the authors of this study.  “It is in these pregnancies where a novel marker that directly correlates with the underlying pathology might have greatest clinical application.”

These experts further conclude that “because the Alere Triage® PLGF test has such a high sensitivity and specificity, its application in the diagnosis of early onset pre-eclampsia should significantly aid diagnosis alongside current methods.” Professor Christopher Redman, Emeritus Professor of Obstetrics at John Radcliffe Hospital, Oxford, concludes that “a reliable and specific test that aids in the diagnosis of those aspects of the pre-eclampsia syndrome that jeopardize the safety of mother and/or unborn baby would be invaluable. Alere Triage® PLGF is a major advance in the assessment for preterm disease.”

Professor Andrew Shennan from Kings College London, co-author of the Lancet editorial, agrees that better diagnostic tests should be used. “At last we have a potential test that can accurately risk discriminate, and provide some logical direction to our clinical decision making.”  Adoption of more specific diagnostic tests for pre-eclampsia, should help to identify those at risk more quickly, improve the standard of care received, reduce maternal and fetal consequences, and help make maternal death a ‘never event’.”

About Alere Triage PLGF

The Alere Triage® PLGF test is a rapid test that takes just 15 minutes to deliver a result from a maternal plasma specimen. By detecting the level of PlGF, it can aid in the identification of those pregnancies in which this hormone is extremely low for gestational age. The intended use of the test is as an aid in the diagnosis of early onset pre-eclampsia.

About Alere
By developing new capabilities in near-patient diagnosis, monitoring and health management, Alere enables individuals to take charge of improving their health and quality of life at home. Alere’s global leading products and services, as well as its new product development efforts, focus on infectious disease, cardiology, oncology, toxicology and women’s health. Alere is headquartered in Waltham, Massachusetts, USA.

For additional information on Alere, please visit www.alere.com

The Alere Logo, Alere, and Triage are trademarks of the Alere group of companies.
This product is not available in the USA.