North East Maternity Services take an innovative approach in the assessment of pre-eclampsia achieving 100% adoption of biomarker testing as recommended by NICE DG23¹ and supported by the Innovation and Technology Payment (ITP) programme and NHS Accelerated Access Collaborative (AAC)².

In the nine months to June 2020, 943 women were tested as suspected of developing pre-eclampsia and 70% of these women were discharged, avoiding hospitalisation.

The ITP initiative has allowed the adoption of the test at no cost to the Trust and the generation of the required data to evaluate the benefit of continued adoption. According to the ITP technical guidance notes², the adoption of the test is expected to offer pregnant women with suspected pre-eclampsia a better risk assessment for adverse outcomes, and those for whom pre-eclampsia has been ruled out can return to community care, instead of being admitted to hospital for observation.²

Eight North East sites[Newcastle / Gateshead/ Sunderland & Tyneside / North Cumbria / North Tyneside / Durham & Darlington /North Tees & South Tees have implemented the Roche Diagnostics Elecsys® sFlt-1/PlGF ratio test within the patient pathway to support with rule out of pre-eclampsia as recommended by NICE DG23 guideline.¹

Current diagnosis of pre-eclampsia relies on proteinuria and blood pressure measurement, both of which are poor predictors, and the presentation of the symptoms is variable^5,6.

The Roche Diagnostics Elecsys® sFlt-1/PlGF ratio test allows direct measurement of both sFlt-1³ and PlGF⁴, which are accurate NICE recommended indicators of pre-eclampsia.

Between October 2019 and June 2020, 943 women across the North East maternity services have benefited from the use of the test in the patient pathway to support clinicians when deciding appropriate management with suspected pre-eclampsia.

Thanks to the adoption of this test, NHS Trusts are expected to offer pregnant women with suspected pre-eclampsia a better risk assessment for adverse outcomes and those for whom pre-eclampsia has been ruled out can return to community care, instead of being admitted to hospital for observation.

Other benefits include potential cost savings due to reduced unnecessary hospital stays, reduced adverse maternal events and saving on clinical staff time.²

During the pandemic the test has been an additional asset to the maternity services to guide their decisions on hospital admission, as suggested by the Royal College of Obstetricians and Gynaecologists (RCOG) in their guidance for maternal medicine services in the evolving pandemic.⁷

The AHSN NENC played a pivotal role in brokering a relationship between Roche Diagnostics and the North East Maternity services which secured the use of tests for pregnant women. As the AHSN NENC were familiar with the ITP process, this ensured a smooth transition logistically.

The ITP Funding will end in March 2021 – North East Maternity services in partnership with Roche Diagnostics are now working with sites on business cases with real life data to make the case for adoption of the Elecsys® sFlt-1/PlGF ratio test beyond the availability of ITP funding, so there is continuity of service.

The Trust specific impact of the adoption of Elecsys® sFlt-1/PlGF ratio test is currently under evaluation.

1. https://www.nice.org.uk/guidance/dg23 (accessed in September 2020)
2. ITP technical guidance notes v5, document on file
3. Pack insert of Elecsys® sFlt-1 catalogue number 05109523190, https://dialog.roche.com/gb/en_gb/eservices.html
4. Pack insert of Elecsys® PlGF catalogue number 05144671190 https://dialog.roche.com/gb/en_gb/eservices.html
5. Zhang J et al., 2001 Obstet Gynecol
6. Zeisler H et al., 2016 NEJM
7. Guidance for maternal medicine services in the evolving coronavirus (COVID-19) pandemic https://www.rcog.org.uk/globalassets/documents/guidelines/2020-07-10-guidance-for-maternal-medicine.pdf

ELECSYS is a trademark of Roche.

Further resources

Pre-Eclampsia Statistics, Tommy’s. https://www.tommys.org/our-organisation/charity-research/pregnancy-statistics/pre-eclampsia. – accessed in Sept 2020

Office for National Statistics, Births in England and Wales 2014

Powe CE et al., 2011 Circulation

Verlohren S et al., 2012 Clin Sci

Verlohren et al., 2014 Hypertension

Vatish, M  et al., 2016 Ultrasound Obstet Gynecol

Cerdeira et al., Hypertension 2019