GlyFN Rapid Point-of-Care Test for Assessing the Risk of Pre-eclampsia
Know the risk. Learn more.
98.5% Sensitivity
Results in 10 minutes
Earlier detection
Easy sample collection
Simple finger prick sample
Point-of-Care Test
Results obtained in 10 minutes
98.5% Sensitivity and 92.8% Specificity1
Can be used as early as 13 weeks gestation
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What is Lumella®?
Lumella® is a rapid point-of-care (POC) test which predicts the risk of pre-eclampsia. The test determines the concentration of the Glycosylated Fibronectin (GlyFN) biomarker, which has increased levels during pre-eclampsia. Studies have shown it is a robust biomarker for the prediction of pre-eclampsia as both an immunoassay, POC test and compared to other biomarkers available. As a simple POC test which only requires a finger prick sample, the Lumella® test can be performed on the ward or in a doctor’s surgery, without needing the blood sample to go the lab.
How do you use the Lumella® GlyFN test?
The Lumella® test can be used in the first, second or third trimesters between 13 – 37 weeks.
The test only requires a 5µl finger prick sample, so there is no venepuncture unlike other pre-eclampsia diagnostic tests.
The blood sample is micropipetted into a buffer solution. The cartridge is inserted into a reader, and the blood-buffer solution is micropipeetted onto the cartridge.
After 10 minutes the results of the GlyFN levels will automatically be printed.
What is Pre-eclampsia?
Pre-eclampsia is a condition that only occurs during pregnancy and increases health risks for both mother and baby if left untreated.
Pre-eclampsia affects 2% – 8% of pregnant women and 1 in 6 will develop pre-eclampsia again in future pregnancies. Up to 6% of UK pregnancies will be affected by pre-eclampsia.
What are the symptoms?
Pre-eclampsia is often characterised by high blood pressure and protein found in the urine. Symptoms include severe and recurrent headaches, swelling of feet, ankles, hands, puffiness of the face, unexpected and abnormal weight gain, vision problems and pain below the ribs.
What are the risk factors?
Women are at increased risk of developing pre-eclampsia due to any of the following:
Complications in previous pregnancy, high blood pressure even before pregnancy, kidney problems, autoimmune disease, twin or more pregnancies, IVF/Assisted reproduction, Diabetic, Obese with BMI > 30, pregnancy after 40 years of age.
Why should you test for Pre-eclampsia?
Most cases of pre-eclampsia may have no effect on the pregnancy. But if it is left undetected and untreated, pre-eclampsia can be a dangerous complication of pregnancy, for mother and baby. Other vital organs can be affected and it can develop into “eclampsia” in 1-2% of pregnancies, which causes fits and even death of mother and baby.
Early symptoms of pre-eclampsia are often ambiguous for accurate clinical stratification. Pre-eclampsia progression is unpredictable, so pre-eclampsia must be diagnosed as soon as possible and managed safely with timely and appropriate treatment.
How do you test for Pre-eclampsia?
As well as taking regular blood pressure readings, urine is be tested for the presence of protein. If pre-eclampsia is suspected, the doctor or midwife will suggest a blood test is done to rule it out or diagnose pre-eclampsia.
Commonly a PlGF biomarker blood test is used, however, studies have shown GlyFN (a different protein which is elevated during pre-clampsia) to be a more reliable biomarker for pre-eclapmsia.
What is the treatment?
The only “cure” for Pre-eclampsia is to give birth, so often health care professionals may induce labour or perform a c-section at 37-38 weeks. Other treatments may include medication to lower blood pressure, anticonvulsants or if they know a pregnancy is high risk, they will advise the pregnant mother to take aspirin.
GlyFN in Clinical Literature
Glycosylated Fibronectin point-of-care test for diagnosis of pre-eclampsia in a low-resource setting: a prospective Southeast Asian population study.
Nagalla et al. 2020. BJOG.
In a prospective case-control study, Nagalla et al. compared the performance metrics of different biomarkers: GlyFN, PAPPA2, PIGF and sFlt-1 levels in 798 participants >20 weeks gestation. Of the 4 biomarkers, the highest performance was found for GlyFN using the point-of-care test, demonstrating the potential of the Lumella POC test for predicting pre-eclampsia.
Maternal serum glycosylated fibronectin as a short-term predictor of preeclampsia: a prospective cohort study.
Huhn, E. A. et al. 2020. BMC Pregnancy and Childbirth.
151 women with risk factors for, or clinical signs and symptoms of, pre-eclampsia were selected from a prospective cohort and maternal serum samples were collected between 20 – 37 weeks gestation to compare biomarker performance. GlyFN, PAPPA2, PlGF and sFlt-1 were measured by immunoassay and GlyFN was also determined using a POC test.
GlyFN had the highest AUROC (performance metric) in the third trimester compared to other biomarkers. The GlyFN immunoassay and POC test showed a correlation of r=0.966, so the POC test is advantageous to enable accurate, rapid and inexpensive prediction of pre-eclampsia.
Maternal serum glycosylated fibronectin as a point-of-care biomarker for assessment of preeclampsia
Rasanen et al. 2015. AJOG.
“GlyFN is a robust biomarker for monitoring pre-eclampsia in both a standard and POC format, which supports its utility in diverse settings.”
GlyFN, PlGF and sFlt1 levels were determined in serum samples from 107 pregnant women. 45/107 were normotensive and 62 were diagnosed with pre-eclampsia.
GlyFN serum levels in the first trimester were significantly higher in women with preeclampsia (P < .01) and remained higher throughout pregnancy (P < .01).
Compared to other biomarkers, GlyFN had the highest AUROC in the third trimester and the highest difference between the normotensive cohort and clinical preeclampsia cohort.
Product information
- Store Test Kits in a cool, dry place between 2–30 °C, (35–86 °F).
- Test cartridges stored in a refrigerator at 2–8 °C (35–46 °F) must be brought to room temperature before opening and using.
- Do not freeze.
