Get ahead of preeclampsia with a simple blood test

First FDA-cleared preeclampsia assays B·R·A·H·M·S™ PlGF plus KRYPTOR™ and B·R·A·H·M·S sFlt-1 KRYPTOR are now available

Insights on preeclampsia management

First FDA-cleared preeclampsia assays B·R·A·H·M·S™ PlGF plus KRYPTOR™ and B·R·A·H·M·S sFlt-1 KRYPTOR are now available

Preeclampsia is a severe complication related to hypertension affecting pregnant women.

This life-threatening disease can only be cured by the delivery of the baby and contributes largely to maternal and neonatal mortality and morbidity. Preeclampsia can start from week 20 and happens up to 6 weeks after delivery.1

The incidence of preeclampsia has nearly doubled in the US from 2007 to 2019 with an acceleration since 20142

Close to 16% of the pregnant women in the US are suffering from hypertensive disorders of pregnancy3 with half of them developing preeclampsia4

Preeclampsia is the cause of 17% of maternal deaths5 and 15% of premature birth in the US

graph The incidence of preeclampsia has nearly doubled in the US from 2007 to 2019 with an acceleration since 20142

pregnant Close to 16% of the pregnant women in the US are suffering from hypertensive disorders of pregnancy3 with half of them developing preeclampsia4
baby Preeclampsia is the cause of 17% of maternal deaths5 and 15% of premature birth in the US
Contents
PRAECIS study: Large, U.S. multicenter study to stratify pregnant women with preeclampsia with severe features
PRAECIS study: Large, U.S. multicenter study to stratify pregnant women with preeclampsia with severe features

Goal of the PRAECIS study6

PRAECIS (Preeclampsia Risk Assessment: Evaluation of cut-offs to Improve Stratification) study was intended to identify and validate a sFlt-1/PlGF ratio to stratify the short-term risk of developing preeclampsia with severe features (sPE) in women with hypertension hospitalized in late pregnancy.

Key results

• At a 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)

• Women with a ratio >=40 were at higher risk for adverse maternal outcomes (16.1% versus 2.8%; relative risk, 5.8; 95% CI, 2.8 to 12.2)

ON-DEMAND WEBINAR: Preeclampsia Risk Assessment Using Angiogenic Biomarkers in Hospitalized Patients: Evidence, Implementation, and Clinical Cases
Learn from Dr. Sarosh Rana, MD, MPH as she discusses the scientific evidence and clinical impact of implementing the angiogenic biomarkers into the management of preeclampsia with severe features.
ON-DEMAND WEBINAR: Preeclampsia Risk Assessment using Angiogenic Biomarkers in Hospitalized Patients
Join Dr. Sarosh Rana, MD, MPH and Dr. Ananth Karumanchi, MD as they discuss the results of the PRAECIS study and the clinical impact of implementing the sFlt-1/PlGF biomarker into preeclampsia patient management.

Conclusion

PRAECIS is the largest prospective U.S. study to date and included 30% Black and 16% Hispanic women. The PRAECIS study clearly demonstrated that in women 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 sPE within the coming fortnight as well as a strong association with adverse outcomes.

Implications for the clinical practice

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

Read the full article at the New England Journal of Medicine Evidence.

PIGF and sFlt-1 assays

BRAHMS PIGF plus KRYPTOR and BRAHMS sFlt-1 KRYPTOR

The Thermo Scientific™ B•R•A•H•M•S™ PIGF plus KRYPTOR™ is to be used in conjunction with the Thermo Scientific™ B•R•A•H•M•S™ sFlt-1 KRYPTOR™ along with other laboratory test and clinical assessments to aid in the risk assessment of pregnant women (singleton pregnancies between gestational age 23+0 to 34+6/7 weeks) hospitalized for hypertensive disorders of pregnancy (preeclampsia, chronic hypertension with or without superimposed preeclampsia, or gestational hypertension) for progression to preeclampsia with severe features (as defined by The American College of Obstetricians and Gynecologists guidelines) within 2 weeks of presentation.

 

Ease of handling7,8

PlGF plus
sFlt-1
Sample volume
70 μL
8 μL
Sample type
Serum, plasma (K2 EDTA)
Serum, plasma (K2 EDTA)
Incubation time
29 min
9 min
Linear direct measuring range
7.6 –4,000 pg/mL
315 –90,000 pg/mL
Limit of Detection
4.9 pg/mL
28.5 pg/mL
Limit of Quantitation
7.6 pg/mL
29.4 pg/mL
Kit stability on board
29 days
29 days
Calibrator
1 point
2 points
Calibration stability
15 days
15 days

BRAHMS KRYPTOR Analyzers

Exceptionally precise, fast and easy

The Thermo Scientific™ B•R•A•H•M•S™ KRYPTOR™ compact PLUS automated random access immunoanalyzer is an user-friendly bench-top instrument that can easily be integrated into any laboratory.

  • Easy and staightforward laboratory routine with less operator intervention
  • Intelligent dilution and separate calibration significantly reduce the need of sample re-run
  • Cost reduction due to efficient sample processing

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Helpful Resources

References
  1. ACOG practice bulletin 222 (2020)
  2. Cameron et al (2022). J Am Heart Assoc. 11:e023791
  3. Ford et al (2022). MMWR CDC. 71(17)
  4. Wen et al (2021). BJOG; 00:1-11.
  5. Joseph et al (2021). Obstst Gynecol; 137:763-71
  6. Thadhani et al (2022). NEJM; https://doi.org/10.1056/EVIDoa2200161
  7. US IFU B·R·A·H·M·S sFlt-1 plus KRYPTOR
  8. US IFU B·R·A·H·M·S PlGF plus KRYPTOR
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