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.
*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
| 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
*
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 |
