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Advancing Accurate Risk Assessment & Clinical Management of Preeclampsia
Introducing the Lumella® GlyFN rapid point-of care test
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 ”
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).
*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
The GlyFN Test is Intended as an Aid in the Diagnosis ® Lumella of Preeclampsia in Women with Suspected Preeclampsia.
Testing period: Gestational age 13-37 weeks
- - New-onset hypertension •
- - New-onset proteinuria •
- - Severe headache •
- - Changes in vision •
- - Abdominal pain •
- - Fetal growth restriction •
Introducing the Lumella GlyFN Point-of Care Test
- - 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 |