B·R·A·H·M·S Clinical Solutions: Preeclampsia Management

Get ahead of preeclampsia with a simple blood test

In May 2023, the US Food and Drug Administration (FDA) cleared a novel blood test with breakthrough designation to aid in the risk assessment and clinical management of preeclampsia.

 

The test, derived from patient serum or plasma and run on an automated immunoassay analyzer, consists of a ratio of two placental biomarker measurements: soluble fms-like tyrosine kinase 1 (sFlt-1) and placental growth factor (PlGF).

Intended use – Thermo Scientific B·R·A·H·M·S sFlt-1/PlGF KRYPTOR Test System

The sFlt-1/PlGF ratio is designed to be used along with other laboratory tests and clinical assessments to aid in the risk assessment of pregnant women who have been hospitalized for hypertensive disorders of pregnancy* to determine if they are at risk of progressing to preeclampsia with severe features* within two weeks. The label indicates use in singleton pregnancies between 23+0 and 34+6/7 weeks gestation.

*As defined by the American College of Obstetrics and Gynecology (ACOG)1

**Preeclampsia, chronic hypertension with or without superimposed preeclampsia, or gestaional hypertension

Key clinical benefits

Improve clinical decision making regarding:

  • Stepped up care and surveillance
  • Patient and medication management
  • Preparation for labor and delivery
  • Transfer to tertiary care center
  • Cost optimization and hospital bed availability

Proven results – PRAECIS clinical study

The PRAECIS (Preeclampsia Risk Assessment: Evaluation of cut-offs to Improve Stratification) study is the largest prospective US study to date and included 30% Black and 16% Hispanic women. The PRAECIS study clearly demonstrated that in women hospitalized with a hypertensive disorder of pregnancy presenting between 23 and 35 weeks of gestation, measurement of serum sFlt-1/PlGF provided stratification of the risk of progressing to severe preeclampsia (sPE) within two weeks of presentation as well as a strong association with adverse outcomes.2

Pregnant woman holding belly

Key results

  • At cut-off of 40, the clinical performance of the
    sFlt-1/PlGF ratio is:
  • 65% PPV (95% CI, 59 to 71)
  • 96% NPV (95% CI, 93 to 98)
  • 94% Sensitivity (95% CI, 89 to 96)
  • 75% Specificity (95% CI, 70 to 79)
  • The ratio performed better than standard clinical measures (area under the ROC, 0.92 versus 0.75)
Predicting maternal and fetal adverse outcomes
40x Women who developed preeclampsia with severe features had sFlt-1/PIGF ratios approximately 40 times higher than those who did not.2
10x The sFlt-1/PIGF ratio was approximately 10 times higher for women who developed adverse maternal outcomes than for patients who did not.2
30x The sFlt-1/PIGF ratio was approximately 30 times higher in women with an adverse fetal and neonatal outcome compared with those without.2
40 Women with an sFlt-1/PIGF ratio ≥ 40 were more likely to deliver (spontaneously or induced) within 2 weeks compared with women with a ratio <40.2

The measurement of sFlt-1/PIGF can be used to determine if patients require stepped up care or if expectant management per ACOG guidelines should be followed.1

Education

Customer and patient stories

Webinars and symposiums

Dr. Champa Woodham and Dr. Rebecca Khan discuss the biomarker blood test for preeclampsia risk assessment.

Preeclampsia Risk Assessment using Angiogenic Biomarkers in Hospitalized Patients – Dr. Sarosh Rana, MD, MPH and Dr. Ananth Karumanchi, MD

Understanding the Challenges in Diagnosis and Implications on Women's Health – Rebecca Khan, MD, FACOG, Veena Joy, MSc, PhD, and Jessica Murphy, MLS(ASCP)CM

References

1.      Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin Summary, Number 222. Obstetrics and Gynecology.          2020;135(6):1492-1495.

2.     Thadhani et al (2022). NEJM; https://doi.org/10.1056/EVIDoa2200161.

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