A recent study published in the New England Journal of Medicine suggests that the Elecsys preeclampsia test from Roche, Basel, Switzerland, can be used as a predictive tool for preeclampsia.1
The preeclampsia test, called Elecsys sFlt-1/PlGF immunoassay ratio, assesses the ratio of two proteins—soluble fms-like tyrosine kinase-1 (sFlt-1) and placental growth factor (PlGF)—found in the mother’s blood. The Prognosis study is the first multicenter, large-sample study to demonstrate the prognostic value of the test to predict the absence of preeclampsia for 1 week, and the development of preeclampsia within the subsequent 4 weeks, in women with clinical suspicion of the syndrome.
Validating the clinical value of measuring sFlt-1/PlGF ratios in women with suspected preeclampsia, the study results demonstrated that addition of the sFlt-1/PlGF ratio to measures of proteinuria and blood pressure results in a better prediction of preeclampsia, and can reduce by 50% the number of women hospitalized prior to preeclampsia diagnosis.2
The study found that an sFlt-1/PlGF ratio of 38 and below can rule out the development of preeclampsia within the next week with a confidence level of 99.3%. Correspondingly, the study also demonstrated that an sFlt-1/PlGF ratio greater than 38 may help predict whether women with suspected preeclampsia will develop the condition within 4 weeks, enabling doctors to identify at-risk patients who need close monitoring.
Preeclampsia accounts for more than four out of every 10 maternal deaths each year globally.3 According to the company, clinical use of the sFlt-1/PlGF ratio to predict and diagnose preeclampsia could help reduce associated healthcare costs, by cutting both inappropriate discharges and unnecessary hospitalizations.
“The emotional benefits of the test are very important: preeclampsia can develop quickly and symptoms can develop even in women who so far have had a healthy pregnancy,” says Harald Zeisler, MD, professor of obstetrics and gynecology at Medical University Vienna, Austria, and a study investigator. “If we can tell a patient with signs or symptoms that she has a low sFlt-1/PlGF value, and therefore a low risk of developing preeclampsia within the short term, that’s a big advantage. On the other hand, women with high sFlt-1/PlGF values can be referred to hospitals with neonatal and adult intensive care units, where they can receive the specialist care they need.”
“The Prognosis study is the first to demonstrate that the Elecsys sFlt-1/PlGF immunoassay ratio can reliably rule out preeclampsia for 1 week,” says Roland Diggelmann, chief operating officer at Roche Diagnostics. “We’re delighted to see the results published in such a world-renowned journal as the New England Journal of Medicine, and confident the findings will have a positive impact on the prediction and clinical management of this serious medical condition. They also support our vision to bring medical value to patients, which will enable proactive disease management and better patient care.”
The Elecsys sFlt-1/PlGF immunoassay is available in all countries accepting the CE mark in Africa, Asia, Europe, Latin America, and the Middle East. The test is not currently available in the United States or Japan. For more information, visit Roche.
- Zeisler H, Llurba E, Chantraine F, et al. Predictive value of the sFlt-1:PlGF ratio in women with suspected preeclampsia. NEJM. 2016;374(1):13–22; doi: 10.1056/NEJMoa1414838.
- Strunz-McKendry T. UK cost-effectiveness analysis of incorporating the sFlt-1/PlGF ratio test into standard clinical practice for diagnosis of preeclampsia and/or HELLP syndrome [e-poster]. Paris: World Congress on Controversies in Obstetrics, Gynecology, and Infertility, December 4–7, 2014.
- Verlohren S, Galindo A, Schlembach D, et al. An automated method for the determination of the sFlt-1/PIGF ratio in the assessment of preeclampsia. Am J Obstet Gynecol. 2010;202(2):161.e1–161.e11; doi:10.1016/j.ajog.2009.09.016.