The NICE Diagnostic Advisory Committee recommends that midwives can use any one of the four tests at between 20 and 36 weeks and 6 days of pregnancy to help make clinical decisions for women presenting with suspected preterm pre-eclampsia
NICE has issued new draft diagnostic guidance authorising the use of one of four blood tests for the diagnosis of suspected preterm pre-eclampsia.
The four tests recommended in the guidance are:
- DELFIA Xpress PLGF 1-2-3 Test
- DELFIA Xpress sFlt-1/Xpress PLGF1-2-3 Ratio
- Elecsys Immunoassay sFlt-1/PLGF Ratio
- Triage PLGF Test.
Professor Andrew Shennan, Professor of Obstetrics at King’s College London, said in a tweet: ‘We have managed to convince NICE to recommend more tests to manage pre-eclampsia. Good for choice.’
The NICE Diagnostic Advisory Committee recommends that midwives can use any one of the four tests at between 20 and 36 weeks and 6 days of pregnancy to help make clinical decisions for women presenting with suspected preterm pre-eclampsia.
Pre-eclampsia is a potentially serious complication of pregnancy, which can be harmful for both mother and baby if left unmonitored and untreated. Around 6% of pregnancies in the UK are affected by pre-eclampsia; of those, 1–2% are severe cases.
Valuable diagnostic tool
Placental growth factor (PLGF) is a protein that plays a key role in the development of blood vessels in the placenta. Pre-eclampsia is often characterised by abnormally low levels of PLGF, which may be an indicator of inadequate placental growth. These tests are designed to quantify the levels of PLGF in the blood, thereby aiding early diagnosis of pre-eclampsia, which translates to better maternal and fetal outcomes.
Women from African, Caribbean, and Asian family backgrounds, who have a higher risk of adverse pregnancy outcomes, are likely to benefit the most from the tests.
Jeanette Kusel, Acting Interim Director for Medtech and Digital at NICE, said: ‘These tests represent a step change in the management and treatment of pre-eclampsia.
‘This is extremely valuable to doctors and expectant mothers, as now they can have increased confidence in their treatment plans and preparing for a safe birth.’
NICE had previously rejected the DELFIA Xpress PLGF 1-2-3 Test because of a lack of adequate data on its accuracy. New, high-quality data now demonstrate good accuracy for this test, and for the DELFIA Xpress sFlt-1/PLGF 1-2-3 Ratio Assay.
NICE had previously recommended the Elecsys Immunoassay sFlt-1/PLGF Ratio and the Triage PLGF Test to rule out pre-eclampsia, but not to diagnose the condition. Newer data indicate that these tests can help to diagnose, as well as to exclude, pre-eclampsia, and are economical compared with standard assessment.
Ms Kusel added: ‘New evidence presented to the committee shows that these tests can help successfully diagnose pre-eclampsia, alongside clinical information for decision-making, rather than just rule it out.’
Currently, there is limited evidence to support a repeat test following an initial negative result; hence, testing is recommended just once when a patient presents with symptoms suggestive of pre-eclampsia.
Dr Mark Kroese, Chair of the NICE Diagnostics Advisory Committee, said: ‘The committee called for further research when it looked at this topic in 2016. Following some excellent research, we can now issue draft guidance for four tests which the NHS can use to help diagnose pre-eclampsia.’
Accuracy of another test, BRAHMS sFlt-1 Kryptor/BRAHMS PLGF Plus Kryptor PE Ratio, is being investigated further.
The guidance will now be open for public consultation, and the final guidance is expected to be published by the end of April 2022.
This article originally appeared on Medscape, part of the Medscape Professional Network.
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