11th May 2016
NHS advised to adopt ground-breaking test to rule-out life threatening pregnancy complication.
New simple blood test manufactured by Roche Diagnostics can rule-out pre-eclampsia within one week with 99.3% accuracy in just 18 minutes.
- Pre-eclampsia is one of the biggest health threats to pregnant women globally and a leading cause of foetal and maternal morbidity and mortality.
- It is estimated to affect around 38,000 pregnant women in the UK each year, however thousands more are suspected of having the condition. 1a,1b
- The new guidance advocates the use of a test manufactured by Roche Diagnostics to confidently rule-out the presence of pre-eclampsia within one week.2
- Use in the UK could reduce hospitalisation of suspected pre-eclampsia cases by 50%3, freeing up beds and reducing pressures on nurses. Annual UK savings are projected to be >£16 million.4
LONDON, UK (11 May 2016) – Today, midwives and doctors in the NHS are being advised to use a ground-breaking test to rule out the life threatening condition of pre-eclampsia in pregnant women. With potential annual UK savings of >£16 million annually, the test has been recommended by NICE in its newly published guidelines on the management of suspected pre-eclampsia.2
Hypertensive disorders like pre-eclampsia affect approximately 13.5 per cent of pregnancies5 and approximately 80,000 pregnant women in the UK may be investigated for suspected pre-eclampsia every year.5 If left unchecked, pre-eclampsia can lead to seizures, coma or even death, and is a leading cause of pre-term birth.
In some cases, there may be no symptoms to warn of hypertension or pre-eclampsia, and often the only way it is detected is during the routine blood pressure and urine checks. Without a reliable test to diagnose the condition, many women are admitted to hospital unnecessarily to undergo further testing and observations, which may involve lengthy in-patient hospital stays. However, most of these women will never go on to develop pre-eclampsia, meaning that many are exposed to unnecessary stress and anxiety in the final months of their pregnancy.
The introduction of this test into clinical practice has the potential to revolutionise the management of the condition, by providing clinicians with the confidence to accurately rule-out the development of pre-eclampsia within one week with a test accuracy of over 99%.6 This means patients can be discharged secure in the knowledge that they are not at risk of developing pre-eclampsia over the next seven days.
The test, which is manufactured by Roche Diagnostics, could reduce hospitalisation by 50 per cent,3 resulting in significant savings for the NHS and also freeing up hospital beds to allow clinicians and midwives to care for those patients most in need.
Severe pre-eclampsia can cause significant distress to both mother and baby, and requires immediate and swift action. Both Kate, 35 and Rob Crussell, 33, from Northampton, can attest to the importance of being aware of all risks. The couple unfortunately lost their 2 day old son Theo due to complications from pre-eclampsia in August 2015 (www.4theo.co.uk). Kate said:
“It breaks my heart that up until 39 weeks, when I suddenly began to show signs of pre-eclampsia, Theo was a healthy baby boy and it was just this horrible disease that killed him. I didn’t fully understand what pre-eclampsia was, even as they were delivering Theo by an emergency C-section. I was told that I was lucky to be alive, and I’m thankful that Theo managed to live for 44 beautiful hours, where we got the opportunity to change him, bathe him and have our family meet and say goodbye to our baby.
“Once you have a miscarriage, stillbirth or neonatal death, the joy in subsequent pregnancies is diminished. The innocence is gone, you realise that death can happen and I dread the thought of future pregnancies knowing that there’s a chance that it could happen again.”
Dr Manu Vatish, Senior Clinical Fellow in Obstetrics, University of Oxford, comments:
“A diagnosis of suspected pre-eclampsia diagnosis can be extremely frightening for women and their families. The condition can be life-threatening and affects around five per cent of all pregnancies.7 Pre-eclampsia symptoms are often non-specific and, without a reliable test to diagnose the condition, many women are admitted to hospital unnecessarily.
“Today’s announcement shows that a new era has arrived in the management of this disease. Research demonstrates that the new test from Roche Diagnostics, which can give a result in 18 minutes, is exceptionally good at ruling out the presence of the disease. Effectively ruling out the disease means reducing unnecessary admissions. Allowing women who are not at risk to go home safely means that the NHS can focus attention on women, such as Kate, who have the greatest need.”
Ann Marie Barnard, CEO, Action from Pre-eclampsia said:
“The prospect of pre-eclampsia can cause untold worry and unease for thousands of expectant mothers, at a time when they should be relaxing and looking forward to birth. Unnecessary hospitalisation adds further stress to not only parents, but also to an NHS that is already under strain. This guidance is a big step towards a greater understanding and provision of treatment for those at risk of pre-eclampsia, resulting in a calmer, easier pregnancy. ”
- ENDS -
Notes to editor:
For more information, please contact:
Roche Diagnostics Press Office – 020 7054 9974 / email@example.com
Pre-eclampsia is a serious pregnancy complication and a global leading cause of maternal deaths during pregnancy, preterm birth and death or ill health of newborns.
Who is at risk?
Typically, pre-eclampsia occurs after 28 weeks of pregnancy. Several factors increase the chances of a woman developing pre-eclampsia including:
- A first time pregnancy
- A pre-eclampsia diagnosis in a previous pregnancy
- A family history of pre-eclampsia
- Pregnancy in early teens or past the age of 40
- A pregnancy of multiple babies (twins or triplets)
- The woman has kidney disease or high blood pressure
- The woman is obese
What are the symptoms?
The symptoms of pre-eclampsia can be difficult to detect because they resemble the “normal” effects of pregnancy on the body. (e.g. nausea, lower back pain, weight gain and swelling of limbs). Many women will experience no symptoms at all.
At present, pre-eclampsia is suspected in any pregnant woman with unexplained high blood pressure and proteinuria in their third trimester.
What are the treatment options?
Pre-eclampsia is a progressive and unpredictable disease, for which the only cure is delivery of the baby. A woman found to be at risk of pre-eclampsia will be closely monitored via regular blood pressure tests, urine samples and ultrasound scans and may also receive medication to lower her blood pressure and enable the pregnancy to continue safely for as long as possible.
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About the pre-eclampsia test
The pre-eclampsia test, called Elecsys® sFlt-1/PlGF immunoassay ratio, assesses the ratio of two proteins sFlt-1 (soluble fms-like tyrosine kinase-1) and PlGF (placental growth factor) found in the mother’s blood. An sFlt-1/PlGF ratio of 38 and below can rule out the development of pre-eclampsia within the next week with a negative predictive value of 99.3%, whilst a ratio above this cutoff value predicts the development of pre-eclampsia within four weeks with a positive predictive value of 36.7%.6 The ratio had previously already been used as an aid in the diagnosis of pre-eclampsia and its associated adverse outcomes for mother and baby.8,9,10
1a 5% of live birth in the UK. The Office of National Statistics (2014) Vital Statistics: Population and Health Reference Tables [Online] London: ONS. Available at:
http://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/datasets/vitalstatisticspopulationandhealthreferencetables [Accessed 3rd May 2016]
1b Chaiworapongsa, T., Chaemsaithong, P., Yeo, L., Romero, R (2014). Pre-eclampsia part 1: current understanding of its pathophysiology. Nat Rev Nephrol. 10(8), 466-80.
2 National Institute for Health and Care Excellence (2016) PlGF based testing to help diagnose suspected pre-eclampsia (Triage PlGF test, Elecsys immunoassay, sFlt-1/PlGF ratio, DELFIA Xpress PlGF 1-2-3 test, and BRAHMS sFlt-1 Kryptor/BRAHMS PlGF plus Kryptor PE ratio). NICE Guideline DG23
3 Strunz-McKendry, T., Allegranza, D., Hund, M., Posnett, J. (2014) Poster presented at 20th World Congress on Controversies in Obstetrics, Gynecology & Infertility (COGI) 4th – 7th December 2014, Paris, France.
4 Data on File: DOF_sFlt/PIFGa_05_16
5 Data on File: DOF_sFlt/PIFGb_05_16 [Adapted from National Institute for Health and Care Excellence (2016) PlGF based testing to help diagnose suspected pre-eclampsia (DG23). Resource impact template. Estimated from prevalence of women with gestational hypertension (13.5% of births), live birth rate in the UK as a whole, and the proportion of women with suspected pre-eclampsia who are between 20 and 34 weeks (75%)]
6 Zeisler, H., Llurba, E., Chantraine, F., et al (2016). Predictive value of the sFlt-1:PlGF ratio in women with
suspected pre-eclampsia N Engl J Med 374:13-22.
7 NHS Choices (2015), ‘Pregnancy-induced hypertension and pre-eclampsia’. Available from: http://www.nhs.uk/conditions/pregnancy-and-baby/pages/pre-eclampsia-pregnant.aspx [last accessed 25.04.2016]
8 Rana, S., Powe, C.E., Salahuddin, S., Verlohren, S., Perschel, F.H., et al. (2012). Angiogenic factors and the risk of adverse outcomes in women with suspected pre-eclampsia. Circulation 125(7), 911-919
9 Verlohren, S., et al. (2012). The sFlt-1/PlGF ratio in different types of hypertensive pregnancy disorders and its prognostic potential in pre-eclamptic patients. Am J Obstet Gynecol 206, 58:e1-8
10 Verlohren, S, et al (2014) New gestational phase-specific cutoff values for the use of the soluble fms-like tyrosine kinase-1/placental growth factor ratio as a diagnostic test for pre-eclampsia. Hypertension 63, 346-352