Lumella test for detection of pre-eclampsia
Research type
Research Study
Full title
Comparison of Glycosylated Fibronectin Test (Lumella®) with sFLT/PLGF ratio test for Assessment of Pre-eclampsia
IRAS ID
329734
Contact name
Amarnath Bhide
Contact email
Sponsor organisation
Advanced Global Health Limited
Clinicaltrials.gov Identifier
329734, IRAS Id
Duration of Study in the UK
1 years, 8 months, 31 days
Research summary
Preeclampsia is a condition affecting 5% of pregnancies, characterised by raised blood pressure and presence of protein in urine. It can result in complications affecting mother with organ failure and is a recognised cause of maternal mortality. It can also result in early delivery which expose baby to short- and long-term complications. Early detection and management improve outcomes and reduce associated risks.
Preeclampsia is associated with increased levels of certain markers in maternal blood. Currently, a test of maternal blood (PlGF/sFlt ratio) is used in NHS to assess risk of developing preeclampsia in suspected cases.
In this study, we will be examining a new test (Lumella) to compare its performance to standard test.
Lumella uses pin prick of blood to provide a bedside result for preeclampsia risk in 10 minutes. It is proposed to replace current test that requires blood sample to be sent to laboratory, meaning longer wait for results, delaying treatment.
We plan to conduct this study in 3 hospitals: St George’s, Epsom and St Helier’s NHS trust. We will offer participation in the study to cases with suspected preeclampsia based on clinical and medical history criteria. In regular settings those cases would be offered current screening test (PlGF/sFlt ratio). Upon discussion with research team and written consent, Lumella test will be performed. Finger prick blood sample will be collected and tested by research team; results will not be shared with neither the participant nor the clinical team.
The treatment and care of participants will be still based on standard test. We will invite participants to 2 further visits in 2 and 4 weeks, if not delivered earlier, repeat Lumella test and PlGF/sFlt ratio will be performed.
Anonymous data about pregnancy, delivery and neonatal outcomes will be collected to be able to compare performance of both tests.REC name
London - Harrow Research Ethics Committee
REC reference
23/PR/0960
Date of REC Opinion
13 Oct 2023
REC opinion
Further Information Favourable Opinion