POINT-OF-CARE TESTING


Despite advances in maternal healthcare, diagnosing and predicting who will develop pre-eclampsia – and when – remains a major clinical challenge


blood pressure, proteinuria, and liver enzymes, PlGF has consistently shown superior diagnostic performance.3


This


has led to the development of several commercial tests measuring PlGF and/ or the sFlt-1/PlGF ratio – each with varying claims regarding diagnostic and prognostic utility.4


Clinical impact of PIGF Large-scale UK trials such as PARROT and INSPIRE have further validated the clinical utility of PlGF-based testing.5,6 The PARROT trial examined PlGF testing alone and found it significantly reduced the time to clinical confirmation and lowered maternal complications, compared to standard care. The INSPIRE trial, which evaluated the sFlt-1/PlGF ratio, showed that the test improved admission decisions, enabling clinicians to identify high-risk patients for appropriate care while safely discharging those at low risk. However, researchers emphasised that biomarker testing should be used in conjunction with clinical judgement. Recognising its strong diagnostic value, the National Institute for Health and Care Excellence (NICE) recommends PlGF-based testing for women with suspected preterm pre-eclampsia between 20 and 37 weeks’ gestation.7


Early identification through PlGF testing allows clinicians to accurately stratify risk, begin timely and appropriate management, and ultimately improve both maternal and fetal outcomes. This represents a significant advancement in addressing one of the most unpredictable complications of pregnancy – while also helping to minimise unnecessary interventions and reduce the burden of excessive monitoring in women at lower risk. To accelerate implementation, the


MedTech Funding Mandate supported the national rollout of PlGF testing in England (2021–2023).8


More recently,


in May 2024, the Scottish Government directed all Health Boards to introduce PlGF-based testing as standard practice.9


The need for POC innovation Despite national guidance and policy support, real-world implementation remains inconsistent. The 2024 Saving Lives report revealed that maternal deaths from pre-eclampsia and eclampsia had not improved since 2019–21 and were four times higher than the lowest recorded rate from 2012–14.10 A major barrier to progress is timely access to PlGF testing. Many hospitals still depend on laboratory-based systems,


POCT PlGF testing would allow earlier risk stratification, reduce unnecessary hospital referrals, and ensure high-risk women are identified and supported much earlier.


often with samples sent off site or processed with limited capacity during evenings and weekends. As a result, turnaround times of 24 hours or more are not uncommon – far too long in time-critical clinical scenarios where rapid decision-making can be life saving for both mother and baby. Point-of-care (POC) testing has the potential to dramatically improve this. By enabling clinicians to test, interpret, and act within minutes, POC tests can reduce unnecessary admissions, support earlier diagnosis, and improve the targeting of care. However, current platforms still have limitations – requiring centrifugation that is impractical in busy maternity units where time, staffing, and space are already under significant pressure. In addition to improving care within hospitals, there is a critical need to extend innovation into the community. Women in rural or remote areas, or from socioeconomically disadvantaged backgrounds, face disproportionate barriers to timely diagnosis and care. The centralised nature of current PlGF testing reinforces these inequalities, as women must travel to secondary care centres to access testing.


Bringing true point-of-care PlGF testing into community settings such as midwifery-led units, or mobile clinics, would be a transformative step toward improving equity of access. It would allow earlier risk stratification, reduce unnecessary hospital referrals, and ensure high-risk women are identified and supported much earlier in their pregnancy journey.


A game-changer in pre- eclampsia diagnostics The Lepzi PIGF test represents a major breakthrough in pre-eclampsia diagnostics. Developed as a true point- of-care test, it enables rapid PlGF measurement directly from whole blood, without the need for centrifugation or laboratory equipment. Designed for ease of use in any clinical setting, Lepzi offers immediate answers; bringing PlGF testing to the bedside.


The test has been evaluated by King’s College London using prospectively collected samples for the PEACHES (Pre- Eclampsia And Chronic Hypertension, rEnal and SLE) study, showing that it has high predictive performance (negative predictive value, NPV) for ruling out pre-eclampsia at 20-37 weeks’ gestation within 2, 7, 14 and 28 days sampling. Its ‘rule- in’ and ‘rule-out’ accuracy, along with threshold values, are comparable to NICE recommended tests – making it a reliable POC option


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