11th May 2016
Clinicians and midwives welcome the introduction of new pre-eclampsia test following landmark study
- New NICE guidance advocates use of Roche Diagnostics’ Elecsys® sFlt-1/PlGF blood test to rule out pre-eclampsia within one week in pregnant women with high blood pressure in their second and third trimester1
- Guidance recommends test after international study finds it 99.3 per cent accurate2
- Potential UK savings of >£16million annually3
LONDON, UK (11 May 2016) – Obstetricians and midwives are today welcoming the publication of new NICE guidance recommending the use of a new test from Roche Diagnostics that can rule-out the development of the life threatening condition, pre-eclampsia, within one week in pregnant women.1
Hypertensive disorders, like pre-eclampsia, currently affect approximately 13.5 per cent of pregnancies in the UK.4 It is estimated that as many as 80,000 pregnant women are investigated for suspected pre-eclampsia each year,4 and the introduction of the test could reduce hospitalisation by 50%5. NICE estimates that the cost reduction per patient of using the sFlt-1/PlGF ratio test rather than standard clinical assessment to rule out pre-eclampsia before 35 weeks is £2,488 in England and Wales.1 Annual UK savings are projected to be >£16 million.3
Previous treatment guidelines have recommended that all women presenting with hypertension and proteinuria are admitted to hospital for monitoring, although most would not go on to develop pre-eclampsia. This unnecessary hospitalisation causes undue stress and anxiety for mothers, as well as significant costs to hospitals and the NHS. In-patient monitoring of potentially pre-eclamptic patients requires additional capacity, clinical hours and staff care, placing additional pressures on an already stretched NHS.
The new assay from Roche Diagnostics allows healthcare professionals to conduct a simple blood test, to determine whether an individual patient will develop pre-eclampsia over the next week. With 99.3 per cent accuracy,2 women deemed not at risk could safely return to community care, instead of being admitted to hospital for further observations.
Within the updated guidance, clinicians and midwives are now advised to use the Elecsys immunoassay sFlt-1/PlGF ratio to measure the levels of placental growth factor (PlGF) in the blood.1 PlGF is a protein involved in the development of new blood vessels in the placenta, and in pre-eclampsia, levels of PlGF can be abnormally low. The ratio also measures soluble FMS-like tyrosine kinase-1 (sFlt-1), a protein which is thought to disable proteins associated with blood vessel formation, such as PlGF. In women who develop pre-eclampsia, the levels of sFlt-1 have been shown to be higher than those seen in normal pregnancy. The sFlt-1/PlGF ratio has shown better diagnostic ability compared to either biomarker alone.6
The NICE consultation drew on evidence from the PROGNOSIS study published in the New England Journal for Medicine, which evaluated the use of Elecsys® sFlt-1/PlGF ratio for short-term prediction of pre-eclampsia/eclampsia/HELLP syndrome in 1,273 pregnant women with suspected pre-eclampsia.2
The study found that the ratio test could exclude pre-eclampsia for one week with a negative predictive value (NPV) of 99.3%. (95% confidence interval [CI], 97.9-99.9) with 80.0% sensitivity and 78.3% specificity. To rule in pre-eclampsia within 4 weeks, the positive predictive value (PPV) was 36.7% (95% CI, 28.4-45.7), with 66.2% sensitivity and 83.1% specificity.
Dr Manu Vatish, Consultant Obstetrician at John Radcliffe, Oxford University Hospital, said:
“Pre-eclampsia affects around three per cent of all pregnancies, but symptoms are often non-specific and, without a reliable test to diagnose the condition, many women are admitted to hospital unnecessarily. Not only does this result in additional stress for the women involved, but it also places pressure on the NHS through unnecessary tests and extra inpatient bed days.
“The new guidance shows that a new era has arrived in the management of this disease. The 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 and is intended to be used alongside clinical judgement. 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 who have the greatest need.”
Linda Holden and Georgina Longley, Midwives at John Radcliffe, Oxford University Hospital, commented:
“Although not every patient presenting with suspected pre-eclampsia will go on to develop the condition, it’s very important to take each case seriously. There is significant unmet need within hypertensive disorders, and this new guidance certainly takes a step towards addressing this. The new test could provide peace of mind for many parents and potentially relieve pressure on the wards and among the antenatal staff.”
- ENDS -
Notes to editor:
For more information, please contact:
Roche Diagnostics Press Office – 020 7054 9974 / firstname.lastname@example.org
Pre-eclampsia is a serious pregnancy complication which is a 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 diagnosis of pre-eclampsia 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.
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 cut off value predicts the development of pre-eclampsia within four weeks with a positive predictive value of 36.7%.2 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.6,7,8
1 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 BRHAMS sFlt-1 Kryptor/BRAHMS PlGF plus Kryptor PE ratio) NICE guideline DG23
2 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
3 Data on File: DOF_sFlt/PIFGa_05_16
4 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%)]
5 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.
6 Verlohren S, Herraiz I, Lapaire O, 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: 346-52.
7 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
8 Verlohren, S, Herraiz I, Lapaire O, 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