New point-of-care test for early diagnosis of preeclampsia

Preeclampsia is a serious condition that can occur in the second half of a pregnancy and carries the potential for serious complications in both the mother and baby.
 
At present, there is no cure, except for delivery of the baby and placenta, which can lead to premature delivery and a host of complications.
 
But Australian researchers have developed a new point-of-care test that could signal hope for earlier detection and intervention.
 
The new strip-based lateral flow assay, developed by a team from the University of Technology Sydney (UTS), uses innovative nanoparticle-based technology to detect the concentration of two novel protein biomarkers – FKBPL and CD44 – present in the blood plasma of women with preeclampsia.
 
To validate the test’s effectiveness, the team conducted a study using clinical samples in collaboration with the Mercy Hospital for Women in Melbourne. The findings show the test has significantly improved sensitivity (90.5% vs 73.7%) and specificity (100% vs 92.3%) compared to the ELISA method, which is the most up-to-date method currently available.
 
Associate Professor Lana McClements is responsible for the discovery of the two novel protein biomarkers.
 
She told newsGP the new test has the potential to be performed at the point-of-care in general practice and produce highly sensitive and specific results within 15 minutes.
 
‘What normally happens is that the pregnant individual gets their blood taken, that blood gets sent off to a lab, and then that normally takes 24 hours, at a minimum, for the results to be to be shown on the system. That’s obviously a lot longer than 15 minutes,’ she said.
 
‘In these circumstances, where preeclampsia comes on really suddenly, unexpectedly and requires immediate clinical attention – even before any serious symptoms are obvious – those immediate clinical decisions are critical.
 
‘We believe this test has the potential to revolutionise the way preeclampsia is diagnosed and managed.’
 
Associate Professor McClements says the test looks very similar to a COVID antigen test, but differs in that it uses a blood sample rather than saliva.
 
Conducting the test requires single use strips, which have been specifically designed to incorporate the antibodies and nanoparticles, and would cost approximately $2 each, and a strip reader, which the authors say should not exceed $100.
 
As it stands, the clinician would have to take the blood sample and spin it down to extract the plasma.
 
Associate Professor McClements says this would work for general practices that have a ‘small centrifuge in their office’, which is more common in rural and remote practices, and where the test could be of most immediate benefit.
 
‘But in the future, there could be a way of just doing a finger prick,’ she said.
 
Preeclampsia affects up to 8% of all pregnancies in Australia, with 1–2% of cases severe enough to be life-threatening for both the mother and baby.
 
Often occurring after 20 weeks gestation, the condition is characterised by high blood pressure, protein in the urine and damage to organs, such as the kidney and liver.
 
However, diagnosing preeclampsia is complicated due to the condition being multifactorial, with varying symptoms and features.
 
But aside from diagnosis, Associate Professor McClements says her discovery could also open doors to new drug and cell therapies to both prevent and treat preeclampsia – a project for which she recently received the Heart Foundation Fellowship, looking at existing pregnancy safe-drugs, as well as developing new treatments.
 
The research could also have benefits beyond pregnancy. According to the study authors, the fully developed lateral flow assay could potentially be applied in detecting a wide range of biomarkers for early diagnosis of various diseases in point of care settings, which they say would be ‘particularly beneficial for remote and rural areas’.
 
Having developed the prototype of the test and clinically validated it, the research team are now at the stage of working to commercialise the test in collaboration with industry partners who can develop it for market.
 
‘Once it gets approved by the regulatory bodies it could potentially be available to patients … in three years’ time,’ Associate Professor McClements predicts.
 
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