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Diagnostic tests for confirming suspected pre-eclampsia – new SHTAC publication

Published: 6 December 2016
Pregnant mother
Pre-eclampsia has potentially serious consequences for mother and/or baby if not treated.

SHTAC researchers have published a systematic review and economic evaluation investigating the diagnostic accuracy and cost-effectiveness of blood tests for rule-in or rule-out of pre-eclampsia in women suspected of having the condition.

Pre-eclampsia is a condition of pregnancy characterised by dysfunction of the placenta, and has potentially serious consequences for the mother and/or baby if not identified and treated. Signs and symptoms of pre-eclampsia include proteinuria and elevated blood pressure. However, not all women who are suspected of having pre-eclampsia according to these signs or symptoms go on to develop pre-eclampsia. In the NHS, routine pregnancy care includes checks for urine protein and blood pressure, but these lack accuracy in diagnosing pre-eclampsia. A new type of test has been developed which measures proteins in the blood that are often abnormal in women with pre-eclampsia; this may help to distinguish between women who require hospital admission for further assessment and those who could safely be monitored by their midwife or family doctor, potentially improving care and saving money.

A SHTAC project, conducted as part of the National Institute for Health and Care Excellence (NICE) Diagnostic Assessments Programme, investigated whether or not the new type of blood test accurately predicts the risk of pre-eclampsia developing in women suspected of having the condition after week 20 of pregnancy. The project involved extensive medical evidence searches, using review methods that minimised the risks of error and bias. Studies on two relevant blood tests were identified and critically scrutinised. These were on the ‘Triage’ placental growth factor test (Alere Inc) and the ‘Elecsys’ test which measures the ratio of two proteins (soluble fms-like tyrosine kinase 1 and placental growth factor) (Roche Diagnostics). The costs and accuracy of these blood tests were used to develop an economic model, to examine whether or not the tests would be cost-effective if used in the NHS. The model results predict that using either the ‘Triage’ test or ‘Elecsys’ test would improve care and save money if used in addition to routine pregnancy care in women with suspected pre-eclampsia in early pregnancy (20–35 weeks) compared with routine pregnancy care alone. However, cost savings for late pregnancy (35–37 weeks) would be small. There is uncertainty around the size of the cost savings, but the tests were both cost-saving even when tested in ‘worst-case’ scenarios. SHTAC’s new study publication provides recommendations to reduce this uncertainty.

SHTAC’s report informed NICE’s guidance on the use of the Triage and Elecsys tests for rule-in and rule-out of preeclampsia. For more information on SHTAC’s diagnostic technologies research please visit our Research page.





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