Elecsys® Preeclampsia (sFlt-1 & PlGF)

Advances in the diagnosis of preeclampsia

  • Preeclampsia is a serious complication in pregnancy which affects both the mother and the unborn child
  • Preeclampsia is a progressive and unpredictable disease that can only be resolved by delivery. The clinical presentation of preeclampsia and subsequent clinical course of the disease can vary tremendously, making diagnostis and assessment of disease progression difficult 
  • The cause of preeclampsia is not fully understood but there is growing evidence that angiogenic factors such as placental growth factor (PlGF) and soluble fms-like tyrosine kinase-1 (sFlt-1) play a major role in the development of preeclampsia

The sFlt-1/PIGF ratio

  • The Elecsys® sFlt-1 and Elecsys® PlGF immunoassays are a reliable automated laboratory test to be used as an aid in the diagnosis of Preeclampsia
  • A simple blood test can now deliver clear, reliable results to help identifying patients at risk for potentially life threatening complications
  • The ELecsys sFlt-1 and PlGF biomarkers have the potential to offer major advances and the diagnosis and management of Preeclampsia

Let's talk about preeclampsia


Elecsys® sFlt-1 Elecsys® PlGF
Assay time 18 min 18 min
Sample material Serum Serum
Sample volume
20 µL
50 µL
Detection Limit approx. 6 pg/mL < 2 pg/mL
Measuring range 10 - 85,000 pg/mL 3 - 10,000 pg/mL
Imprecision < 5% < 5%

Clinical performance of the Elecsys® sFlt-1/PlGF ratio

Excellent clinical performance with a single cut-off of 85: sensitivity 82%; specificity 95%

Early-onset preeclampsia: rule-in cut-off of 85 with 99.5% specificity and rule-out cut-off of 33 with 95% sensitivity

Late-onset preeclampsia: rule-in cut-off of 110 with 95.5% specificity and rule-out cut-off of 33 with 89.5% sensitivity

preeclampsia-1

Reliable assays for the early detection of preeclampsia

  • Elecsys sFlt-1 and PIGF immunoassays for preeclampsia are the first approved automated diagnostic test for a fast and easy assessment in a clinical context

Timely diagnosis for improved outcomes

  • Early and precise diagnosis leading to effective clinical management and improving the outcome for mother and child

Reliable results

  • The sFlt-1/PIGF ratio is a reliable tool to discriminate between different types of pregnancy-related hypertensive disorders supporting the clinicians in the differential diagnosis of preeclampsia

The PROGNOSIS study

Verlohren, S. et al. (2010). An automated method for the determination of the sFlt-1/PIGF ratio in the assessment of preeclampsia. Am J Obstes Gynecol 202:161, e1-11.
Summary:
Elecsys automated assays allow fast and easy assessment of sFlt-1, PlGF and the sFlt-1/PlGF ratio in a clinical context. The sFlt-1/PlGF ratio has a superior diagnostic ability compared to either of the biomarkers alone. Calculation of the sFlt-1/PlGF ratio can assess preeclampsia with high sensitivity and specificity.

Verlohren, S., Stepan, H., Dechend, R. (2012). Angiogenic growth factors in the diagnosis and prediction of pre-eclampsia. Clin Sci (Lond) 122(2), 43-52.
Summary:
Second trimester sFlt-1/PIGF ratio was found to be useful as an aid in the prediction and diagnosis of preeclampsia. The addition of sFlt-1/PIGF to Doppler ultrasound was found to improve the sensitivity and specificity of Doppler ultrasound alone.

Hagmann, H. et al. (2012). The promise of angiogenic markers for the early diagnosis and prediction of preeclampsia. Clin Chem 58(5), 837-45.
Summary:
Angiogenic markers, in particular sFlt-1/PlGF, have been shown to be useful in the differential diagnosis of hypertensive disorder of pregnancy and in predicting the development of adverse outcomes and preterm delivery.

Verlohren, S. et al. (2012). The sFlt-1/PlGF ratio in different types of hypertensive pregnancy disorders and its prognostic potential in preeclamptic patients. Am J Obstet Gynecol; 206, 58.e1-8.
In preeclampsia/HELPP the sFlt-1/PIGF ratio is significantly higher than in other hypertensive disorders in pregnancy and controls and indicates an increased risk of imminent delivery. The sFlt-1/PIGF ratio may therefore have clinical value for clinical management, counseling and risk anticipation.

Rana, S. et al. (2012). Angiogenic factors and the risk of adverse outcomes in women with suspected preeclampsia. Circulation 125(7), 911-9.
Summary:
The sFlt-1/PlGF ratio correlates with a higher risk of adverse outcomes and imminent delivery especially in women presenting at < 34 weeks. In women with suspected preeclampsia presenting at 34 weeks, circulating sFlt1/PlGF ratio predicts adverse outcomes occurring within 2 weeks. The accuracy of this test is substantially better than that of current approaches and may be useful in risk stratification and management.