Preeclampsia Screening
Accurate Risk Assessment &
Clinical Management
of Preeclampsia
Clinical Management
of Preeclampsia
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Introducing the GlyFN ®Lumella rapid point-of care test
The GlyFN Test is Intended as an Aid in the Diagnosis of Preeclampsia in Women with Suspected Preeclampsia.
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Early Symptoms of Preeclampsia are often too Ambiguous for Accurate Clinical Stratification
- Clinical presentations often involve uncertain indications of hypertension and proteinuria
- Less than 40% of women exhibit both hypertension and proteinuria before the development of overt preeclampsia
- Preeclampsia progression is unpredictable and often complicated by adverse outcomes
“ Biochemical markers can improve accurate clinical stratification and expectant management ”
Dr. Michael Gravett, Dept of Obgyn, University of Washington Medical Centre, Seattle, USA
Glycosylated Fibronectin (GlyFN) Levels are Elevated in Preeclampsia*
In an observational cohort of 107 pregnant women, 45 normotensive and 62 diagnosed with preeclampsia, glycosylated fibronectin (GlyFN) levels were elevated as early as the first trimester (p<0.001)
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*Rasanen et al. Maternal serum glycosylated fibronectin as a point-of care biomarker for assessment of preeclampsia. American Journal of Obstetrics and Gynecology 2015;212:82.e1-9
The Lumella GlyFN Point-of Care Test Accurately Estimates Risk in Women with Suspected Preeclampsia
In a prospective, observational study (SUPERIOR study, 2016-2018), conducted in India among a cohort of 599 women suspected of preeclampsia, GlyFN as a single biochemical marker showed the highest test performance for risk stratification of preeclampsia.
Normal GlyFN | 50-250 µg/mL | Correlated with normal pregnancy with high sensitivity of 98.2% and high Negative Predictive Value of 99.4% |
Positive GlyFN | 351-600 µg/mL | Correlated with biochemical diagnosis of preeclampsia with 98% Positive Predictive Value |
High Positive GlyFN | > 600 µg/mL | Correlated with risk of severe preclampsia with 99% Positive Predictive Value |
Testing period: Gestational age 13-37 weeks
New-onset hypertension
New-onset proteinuria
Severe headache
Changes in vision
Abdominal pain
Fetal growth restriction
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Introducing the Lumella GlyFN Point-of Care TestN
Measures glycosylated fibronectin (GlyFN)
Uses 5 µL finger prick blood sample
Results in 10 minutes
Clinical Interpretation of Test Results
GlyFN range | Test Result | Interpretation |
---|---|---|
50-250 µg/mL | Normal | 99.4% Negative Predictive Value for normal pregnancy |
251-350 µg/mL | Abnormal | Mild or Developing Preeclampsia, repeat testing in 2 weeks |
351-600 µg/mL | Positive | 98% Positive Predictive Value for diagnosis of preeclampsia |
>600 µg/mL | High Positive | High risk of severe preeclampsia and adverse outcomes |