New blood tests aim to show who’s at risk of preeclampsia​

Expectant mothers can now breathe a sigh of relief after a new rapid test showed promise in identifying cases of preeclampsia in pregnant women, particularly those at risk.

A pilot study conducted in five counties by Labflow Kenya, a healthcare diagnostics company targeting high-prevalence diseases, found that the Test-it Protein-Creatinine (PrCr) Urine Dipstick Test increased the detection and diagnosis of pre-eclampsia in patients by 80 to 500 per cent. In Nairobi, the kit increased the detection rate by 53 per cent, with over 2,000 pregnant mothers screened.

The PrCr test, manufactured by LifeAssay Diagnostics in South Africa, is a screening test kit specifically designed to detect preeclampsia by measuring the protein-to-creatinine ratio in urine (proteinuria)- a key indicator of the condition.

PrCr test results are available in 60 seconds and come with an easy-to-read colourimetric scale to support rapid clinical decision-making for improved health outcomes.

A single test kit costs Sh75 and a kit of 50 tests costs Sh3,750. The kit can be used without traditional laboratory equipment and has no specific storage requirements.

The pilot study showed that the Test-it PrCr screening tool is effective for early diagnosis of pre-eclampsia in pregnant women. The tool was used in six facilities and showed promise for use in real-world healthcare settings, especially in areas with high antenatal care attendance.

The results showed that around 9.5 per cent of mothers screened tested positive for proteinuria within one month. The study showed that a large number of these cases occurred in teenage mothers, highlighting the need for targeted screening efforts in this population.

"The Test-it PrCr test strips are effective due to their affordability, simplicity and suitability for point-of-care use, which differentiates them from traditional protein-only dipsticks. The inclusion of creatinine in the test compensates for urine dilution, improving its accuracy in diagnosing pre-eclampsia. These results indicate that the Test-it PrCr Test Kit shows promise in improving early detection of pre-eclampsia, which could lead to prompt treatment and potentially reduce hospitalisation rates," said Kyle Pereira, a pharmacist at Labflow Kenya.

The study highlights the importance of improving access to pre-eclampsia screening dipsticks and diagnostic guidelines in antenatal clinics. While the Test-it PrCr tool demonstrates higher accuracy than traditional urine dipsticks, Mr Pereira notes that its effectiveness depends on healthcare workers' understanding of pre-eclampsia diagnosis and management.

Preeclampsia is a serious condition that affects pregnant women worldwide and poses significant risks to both mother and baby. It is characterised by high blood pressure and often the presence of protein in the urine after 20 weeks of pregnancy. Prompt medical attention is needed to prevent complications that could lead to eclampsia.

According to research published in the National Library of Medicine, the risk of a pregnant woman dying from preeclampsia in a developing country is about 300 times higher than in developed countries.

According to Mr Pereira, preventing serious clinical complications of preeclampsia, including maternal and neonatal death, requires accurate and timely identification of women at high risk and linking them to appropriate care.

However, he notes that the current diagnostic tools available to detect proteinuria in developing countries have significant limitations.

“Protein-only urine dipsticks are widely used at the point of care, but have significant accuracy limitations. In addition, access to laboratory-based tests for improved detection of proteinuria, such as the 24-hour urine test, remains very limited due to technical complexity and cost,” he says.

A spot urine test, he says can be used to determine the ratio of protein to creatinine and improve the accuracy of proteinuria detection compared to measuring protein alone by adjusting for the dilution of a patient's urine sample.

Results using a PrCr measurement have previously shown a close correlation with the current reference standard for proteinuria detection - a 24-hour urine collection test.

Despite medical advances and prevention efforts, pre-eclampsia remains a leading cause of maternal and infant mortality worldwide.

"We expect the number of women suffering from pre-eclampsia to be much higher due to reporting issues, especially in rural areas of the country," said Mr Pereira.

"If pre-eclampsia is not treated, mothers can develop high-risk conditions such as chronic hypertension, diabetes, ischaemic heart disease and kidney disease," he noted.

According to the World Health Organization, hypertensive disorders of pregnancy contribute to approximately 14 per cent of maternal deaths worldwide, with the vast majority - 99 per cent occurring in low- and middle-income countries, making it one of the most common complications of pregnancy.

Data from Labflow, in collaboration with the Ministry of Health, indicates that up to 9 per cent of pregnancies in Kenya develop pre-eclampsia, with approximately 6 per cent of those affected requiring hospitalisation due to severe pre-eclampsia or eclampsia.

While the exact cause of pre-eclampsia is still unknown, Mr Pereira noted that factors such as genetics, immune system disorders and insufficient blood flow to the uterus may contribute to its development.

Pre-eclampsia not only threatens the health of the mother, but also increases the risk of premature birth, low birth weight and other complications for the baby.

The study found that pre-eclampsia disproportionately affects women in low- and middle-income countries, where access to quality maternal health services may be limited.

Therefore, addressing disparities in access to and delivery of health care is critical to reducing maternal and infant mortality in these regions.

"Initiatives to strengthen health infrastructure, train health workers and raise community awareness of maternal health issues can bridge the gap in pre-eclampsia care and improve outcomes for vulnerable populations," said Mr Pereira.

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