Australian researchers have designed a rapid new pre-eclampsia test that will enable the early diagnosis of the potentially life threatening pregnancy complication.
The test takes only 15 minutes to complete and is significantly faster and more accurate than current diagnostic methods.
And because it can be performed at point-of-care, such as a pre-natal clinic or doctor’s office, the test will enable healthcare providers to make immediate and informed clinical decisions for their patients, which is critical for good pregnancy outcomes.
“We believe this test has the potential to revolutionise the way pre-eclampsia is diagnosed and managed,” says Lana McClements, Associate Professor in the School of Life Sciences at the University of Technology Sydney (UTS), and senior author of the research in the journal Angewandte Chemie.
What is pre-eclampsia?
Pre-eclampsia is a cardiovascular complication of pregnancy that affects about five to eight per cent of all pregnancies in Australia. It can develop at any time in the second half of pregnancy, after 20 weeks’ gestation.
It is a progressive disorder that, if not detected early, can lead to severe pregnancy complications including eclampsia – where high blood pressure causes seizures during pregnancy – HELLP (haemolysis, elevated liver enzyme, low platelet count) syndrome, preterm birth and death.
Currently, the disorder is diagnosed through blood pressure measurements and testing for protein in the urine, along with other clinical symptoms such as oedema (swelling). But because there isn’t a single genetic cause of pre-eclampsia, and its symptoms and features vary, accurate diagnosis can be missed or delayed – especially for those living in rural and remote areas.
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How accurate is this new pre-eclampsia test?
The new test detects the presence of two novel protein biomarkers of pre-eclampsia, in the blood plasma of pregnant individuals – FKBPL and CD44, which were discovered by McClements.
The team validated the test’s effectiveness using clinical samples from the Mercy Hospital for Women in Melbourne and found that the test correctly returned a positive result for an individual with pre-eclampsia 90.5% of the time (sensitivity), and correctly returns a negative result for an individual without pre-eclampsia 100% of the time (specificity).
This is significantly improved compared to the current standard ELISA method, which has a sensitivity and specificity of 73.7% and 92.3%, respectively.
“This essentially gives clinicians the ability to make immediate and life-saving informed decisions, and not wait 24 hours for the results to come back,” says McClements.
Biomarkers show potential as targets for new treatments
Currently, the only known cure for pre-eclampsia is delivery of the baby and placenta, which can lead to complications and hospitalisations in the case of premature delivery.
But this might be set to change.
“In addition to the new test, the novel biomarkers also show potential as drug and cell therapy targets of emerging treatments for preeclampsia. This offers hope not only for earlier diagnosis, but also for a future cure to this terrible disorder,” says McClements.
The team is now working to commercialise the test and hopes to eventually make it available for healthcare providers worldwide.
“This is a major advance over current methods of diagnosis, which can be unreliable and time-consuming. Our test has the potential to make a real difference for both mothers and babies,” she concludes.