The most reliable biochemical screening test  for prenatal detection of preeclampsia!

Προεκλαμψία

Preeclampsia is a complication that occurs only during pregnancy and is the main cause of fetal and maternal mortality and mortality as well as the main cause of premature birth worldwide.

For more information on pre-eclampsia see our brochure here…

 

General Information
Preeclampsia is characterized by increased blood pressure and elevated levels of protein in the urine (proteinuria) after the 20th week of gestation and up to 48 hours postpartum. Other clinical symptoms of preeclampsia include strong headaches, sudden edema of the face, the hands and feet, and upper abdominal pain.

Preeclampsia occurs in about 1 every  20 pregnancies and is the second most important cause of maternal death. The condition can threaten the life of both the mother and the fetus, especially if it is not diagnosed early, and in its acute form is a sign of immediate premature childbirth. Most cases involve healthy women who give birth to their first child. Diseases such as chronic hypertension, diabetes and nephropathies are associated with an increased risk of preeclampsia.

Pre-eclampsia can lead to a reduction in intrauterine fetal growth (IUGR), acute renal or hepatic failure, HELLP syndrome (hemolysis, elevated liver enzymes and low platelets) and seizures (eclampsia) in the mother. Currently, the only treatment for Preeclampsia is artificial birth induction and safe removal of the placenta, despite the potential risk to the fetus.

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Preeclampsia Screening

Pre-eclampsia is a progressive and unpredictable disease, which is generally asymptomatic and can only be detected by typical prenatal screening tests.

Currently, screening and monitoring of Pre-eclampsia involves the detection of elevated blood pressure and proteinuria, and in some obstetric centers detection of plaque deficiency by Doppler uterine artery flowmeter.

 

Potentially early diagnosis of Preeclampsia allows for closer monitoring and early intervention, such as use of corticosteroids and scheduled preterm delivery, improving outcome for the fetus and pregnancy.

However, both hypertension and proteinuria prove to be indicators with limited predictability for the clinical manifestation of the disease as well as its course.

 

New data in the Preeclampsia Screening

Although the exact cause of Preeclampsia is unknown, it is thought to arise from a disturbance in the balance between plaque-angiogenic factors.

The Elecsys pre-eclampsia test measures two placental proteins, sFlt-1 (soluble fms tyrosine kinase 1) and PlGF (placental growth factor) in maternal blood.

Women who develop pre-eclampsia have higher sFlt-1 and lower levels of PLGF compared to women who have normal pregnancy.

The concentrations of sFlt-1 are increased and the PLGF decreases not only in acute pre-eclampsia but also several weeks before the onset of clinical symptoms, the measurement of the ratio of these angiogenic proteins is applied as a valuable aid in early diagnosis and in the pre-eclampsia screening. International studies demonstrate that the ratio of sFlt-1 to PlGF is a better indicator for Pre-eclampsia compared to individual marker measurement.

Depending on the result of the test, calculated from the ratio of the two proteins, the gynecologist can reliably exclude or reliably predict the onset of the short-term illness and focus with certainty on those women at high risk of pre-eclampsia.

Applying to clinical practice offers the ability to reduce morbidity and mortality for embryos and mothers, while preventing unnecessary hospitalization and reducing the anxiety of the mother and her family.

 

With the new test, the low sFlt-1 / PlGF protein ratios predict the absence of pre-eclampsia, eclampsia and HELLP syndrome for one week while high ratios predict pre-eclampsia, eclampsia and HELLP syndrome within four weeks.

Guidelines

The NICE * guidelines (2008) propose the investigation of the following risk factors for preeclampsia during the first visit to the gynecologist:

  • Age 40+, first pregnancy, interval between two pregnancies over 10 years, family history of Pre-eclampsia, body weight-index ≥ 35,
  • Pre-existing vascular disease such as hypertension,
  • Pre-existing kidney disease and multiple pregnancies,
  • Diastolic pressure ≥ 80mmHg and
  • Proteinuria ≥ 0.3 g / 24h.

According to NICE guidelines, more frequent blood pressure measurement should be performed in women with any of the above mentioned risk factors.

 

Clinical Value
  • Immediate identification of pregnant women with a risk of developing Pre-eclampsia before clinical symptoms occur.
  • Confirmation of diagnosis of Preeclampsia in suspected patients with hypertension and proteinuria.
  • Timely and effective intervention to ensure optimal care and outcome for mother and child.
  • Assess the criticalness of the disease to obtain the most appropriate patient management decisions.

Continuous studies demonstrate and suggest that the combined measurement and evaluation of sFlt-1 and PlGF serum biomarkers provides an innovative tool that helps diagnose, monitor and manage preeclampsia in the future.

The Elecsys sFlt-1 and PlGF immunoassays are the first available automatic diagnostic tests to be used in the diagnosis of pre-eclampsia (sFlt-1 / PlGF, best cut off: 85). These simple tests in the pregnant woman’s blood can give reliable results with 95% specificity and 82% sensitivity to identify women at increased risk of developing complications that threaten the life of the pregnant woman and the fetus.

 

Testing Procedure
The test for the screening of preeclampsia requires a simple blood draw from the arm of the pregnant women from the 20th week and onwards.

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What is the use of PlGF measurement in the first trimester for the detection of pre-eclampsia?

Combined screening for preeclampsia between 11-13 weeks of pregnancy in addition to prenatal first trimester testing can reliably identify women who are at risk of developing pre-eclampsia.

The combined first trimester test includes:

  • measurement of PlGF and PAPP-A in the pregnant blood serum,
  • Median Blood Pressure (MAP) determination, and
  • measurement of uterine artery pulse rate index (UAPI) resulting in a detection rate of> 90% and 5% false positives.

Early identification of high risk women allows for preventive measures and enhanced monitoring.

Administration of low-dose aspirin (<150 mg / day) to high-risk women before the 16th week of gestation can significantly reduce the incidence of pre-eclampsia by 50% -90%.

 

References
  • National Institute for Health and Clinical Excellence (NICE) (2011). Hypertension in pregnancy. NICE clinical guideline 107, London: RCOG Press.
  • ACOG Task Force on Hypertension in Pregnancy (2013). Hypertension in Pregnancy. Obstet Gynecol. 122, 1122-1131.
  • DGGG (2014). Diagnostik und Therapie hypertensiver Schwangerschaftserkrankungen. [http://www.awmf.org/uploads/tx_szleitlinien/015018l_S1_Diagnostik_Therapie_hypertensiver_Schwangerschaftserkrankungen_2014-01.pdf]
  • Chaiworapongsa, T. et al. (2014). Nat Rev Nephrol 10, 466–480
  • Rana, S., et al. (2012) Circulation 125:911-9.
  • Ένθετα συσκευασίας Elecsys® sFlt-1 και Elecsys® PlGF (Νοέμβριος 2014). Roche Diagnostics Documentation, Basel.
  • Uzan, J., Carbonnel, M., Piconne, O., Asmar, R., Ayoubi, J.M. (2011). Pre-eclampsia: pathophysiology, diagnosis, and management. Vasc Health Risk Manag, 7: 467-474.
  • Roberts, J.M., Cooper D.W. (2001). Pathogenesis and genetics of pre-eclampsia. Lancet, 357: 53-6.
  • Brown, M.A., Lindheimer, M.D., de Swiet, M., Van Assche, A., Moutquin, J.M. (2001) The classification and diagnosis of the hypertensive disorders of pregnancy: statement from the International Society for the Study of Hypertension in Pregnancy (ISSHP). Hypertens Pregnancy, 20(1): IX-XIV.
  • WHO recommendations for Prevention and treatment of pre-eclampsia and eclampsia (2011).
  • Verlohren, S., Stepan, H., & Dechend, R. (2012). Angiogenic growth factors in the diagnosis and prediction of pre-eclampsia. Clin Sci, 122(2): 43-52.
  • Akolekar, R., Syngelaki, A., Sarquis, R., Zvanca, M. and Nicolaides, K. H. (2011), Prediction of early, intermediate and late pre-eclampsia from maternal factors, biophysical and biochemical markers at 11–13 weeks. Prenat. Diagn., 31: 66–74.
  • Bujold Ε,  Roberge S, Lacasse Y, Bureau M, Audibert F, Marcoux S, Forest JC, Giguère Y. Prevention of preeclampsia and intrauterine growth restriction with aspirin started in early pregnancy: a meta-analysis.  Obstet Gynecol 2010; 116: 402-14
  • Park, F., Russo, K., Williams, P., Pelosi, M., Puddephatt, R., Walter, M., Leung, C., Saaid, R., Rawashdeh, H., Ogle, R. and Hyett, J. (2015), Prediction and prevention of early-onset pre-eclampsia: impact of aspirin after first-trimester screening. Ultrasound Obstet Gynecol, 46: 419–423.