The Lumella® Test, The New Point-of-Care Blood Test Helps in Early Detection of Preeclampsia
The Lumella® test estimates the concentration of Glycosylated Fibronectin, a new pregnancy specific biomarker to accurately assess the risk of preeclampsia.
The Lumella® test requires a simple finger stick and can be performed in physician’s office/clinic in the first, second, or third trimesters, between 13 to 37 weeks of gestation.
What is Preeclampsia?
Preeclampsia is a potentially life-threatening disorder that occurs during pregnancy or the postpartum period. It affects 5-8% of all pregnancies and is characterized by high blood pressure, presence of protein in the urine. Symptoms include swelling, sudden weight gain, recurrent headaches, changes in vision, upper abdominal pain, nausea and vomiting. Some women with preeclampsia may not show any symptoms. Progression to severe preeclampsia is unpredictable. Early detection of preeclampsia prevents adverse complications and improves maternal and fetal outcomes.
LEFT UNDETECTED, PREECLAMPSIA CAN RAPIDLY PROGRESS TO A POTENTIALLY FATAL CONDITION
Key Statistics About Preeclampsia
- Hypertensive disorders of pregnancy (HDPs) complicate 5-10% of all pregnancies worldwide. They include: preeclampsia (with or without severe features), eclampsia (seizures), HELLP syndrome (hemolysis, elevated liver enzymes, low platelets), and gestational hypertension.[1]
- Preeclampsia is most often characterized by a rapid rise in blood pressure that can lead to seizure, stroke, multiple organ failure, and death of the mother and/or baby.
- HDPs are a leading cause of maternal and infant death worldwide[2], with the majority of these deaths happening in low- and middle-income countries (LMICs).
- Approximately 76,000 women and 500,000 babies die each year worldwide.[3]
- The United States currently ranks 47th worldwide for maternal mortality, and is the only industrialized nation with a rising maternal mortality rate.[4]
- HDPs, including preeclampsia, are a leading cause of maternal and infant illness and death here in the United States.[5]
- Black women experience severe maternal morbidity events at a rate 2.1 times greater than white women.[6]
Source: Preeclampsia.org
(tambien disponible en Español)
(tambien disponible en Español)
Risk Factors
Preeclampsia is a common complication of pregnancy that can harm you and your baby. Risk factors include:
Lumella® A Point-of-Care Test for Preeclampsia
Lumella® Preeclampsia Test
A new point-of-care blood test to help determine your risk for Preeclampsia
This test only requires a simple finger stick and can be performed in your physician’s office during the first, second, or third trimester of your pregnancy.
Not available for sale in the USA.
Granted FDA breakthrough status on December 5, 2019.
Reference Materials
Lumella® Brochure
Lumella® Test Quick Reference Guide
(Italian version)
Quick Reference Guide Addendum
(Italian version)
Lumella® Test Video Procedure
Lumella® Patient Education:
Headaches Brochure | Weight Brochure | Symptoms Brochure
Publications
- Sokratous, N., Wright, A., Syngelaki, A., Kakouri, E., Laich, A. and Nicolaides, K.H. (2023), Screening for pre-eclampsia by maternal serum glycosylated fibronectin and angiogenic markers at 36 weeks’ gestation. Ultrasound Obstet Gynecol. Accepted Author Manuscript.
- Sokratous, N., Bednorz, M., Syngelaki, A., Wright, A., Nicolaides, K.H. and Kametas, N.A. (2023), Prediction of superimposed pre-eclampsia by serum glycosylated fibronectin and angiogenic factors in women with chronic hypertension. Ultrasound Obstet Gynecol. Accepted Author Manuscript
- Sokratous, N., Bednorz, M., Sarli, P., Morillo Montes, O.E., Syngelaki, A., Wright, A. and Nicolaides, K.H. (2023), Screening for pre-eclampsia by maternal serum glycosylated fibronectin at 11−13 weeks’ gestation. Ultrasound Obstet Gynecol, 62: 504-511. https://doi.org/10.1002/uog.26303
- Sokratous, N., Bednorz, M., Wright, A., Nicolaides, K.H. and Kametas, N.A. (2023), Prediction of imminent pre-eclampsia by serum glycosylated fibronectin in women with new onset hypertension. Ultrasound Obstet Gynecol, 62: 653-659. https://doi.org/10.1002/uog.27458
- Moungmaithong, S., Wang, X., Lau, C.S.L., Tse, A.W.T., Lee, N.M.W., Leung, H.H.Y., Poon, L.C. and Sahota, D.S. (2023), Glycosylated fibronectin improves first trimester prediction of pre-eclampsia. Ultrasound Obstet Gynecol, 62: 512-521. https://doi.org/10.1002/uog.27451
- Lumella® point-of-care test for assessing pre-eclampsia risk
Medtech Innovation Briefing March 1, 2022, National Institute of Health and Care Excellence UK - Nagalla SR, Janaki V, Vijayalakshmi AR, Chayadevi K, Pratibha D, Rao PV, Sage KM, Nair-Schaef D, Bean E, Roberts CT Jr, Gravett MG. Glycosylated fibronectin point-of-care test for diagnosis of pre-eclampsia in a low-resource setting: a prospective Southeast Asian population study. BJOG 2020;127:1687–1694.
- Rasanen J, Quinn MJ, Laurie A, et al. Maternal serum glycosylated fibronectin as a point-of-care biomarker for assessment of preeclampsia. Am J Obstet Gynecol 2015;212:82.e1-9.
- Huhn, E.A., Hoffmann, I., Martinez De Tejada, B. et al. Maternal serum glycosylated fibronectin as a short-term predictor of preeclampsia: a prospective cohort study. BMC Pregnancy Childbirth 20, 128 (2020).
- Rasanen J, Snyder C, Rao P, et al. Glycosylated fibronectin as a first-trimester biomarker for prediction of gestational diabetes. Obstet Gynecol 2013;122:586-94.
- D. Karoutsos, Z. Fasoulakis, S. Michala, K. Stefanidis, P. Antsaklis, Glycosylated Fibronectin as a wide-spectrum biomarker in pregnancy. HJOG 2023, 22 (2), 49-55 | doi: 10.33574/hjog.0524
- Point-of-Care Test for Preeclampsia: Glycosylated Fibronectin. ObGProject.com
- Choudhury SS, Nath T. A cross sectional study to assess the efficacy of glycosylated fibronectin (GlyFn) estimation in prediction of the severity of disease in new onset hypertension in pregnancy from 24 weeks to term. The New Indian Journal of OBGYN. 2023; 9(2): 204 – 8.
- Kesireddy, S., Reddy, P., Gayathri, V. et al. Glycosylated Fibronectin Point-of-care Test for Triage and Surveillance of Hypertension in Pregnancy Cases: A Retrospective Observational Case Control Study. J Obstet Gynecol India 72 (Suppl 1), 121–125 (2022). https://doi.org/10.1007/s13224-021-01566-y
- Sruthi Alahari, Jonathan Ausman, Tyler Porter, Chanho Park, Ante B V Pettersson, Miira M Klemetti, Jianhong Zhang, Martin Post, Isabella Caniggia, Fibronectin and JMJD6 Signature in Circulating Placental Extracellular Vesicles for the Detection of Preeclampsia, Endocrinology, Volume 164, Issue 4, April 2023, bqad013, https://doi.org/10.1210/endocr/bqad013
- Saranya S., Saraswathy K., Dr. Latha Venkatesan, Dr. Vijayalakshmi (2023). Effectiveness of capacity building programme on the competency of predicting preeclampsia by using glycosylated fibronectin as a point of care biomarker among staff nurses. International Journal of Advance Research, Ideas and Innovations in Technology, 9(1) www.IJARIIT.com
Citations
- Ye, C., Ruan, Y., Zou, L., Li, G., Li, C., Chen, Y., … Zhang, W. (2014). The 2011 Survey on Hypertensive Disorders of Pregnancy (HDP) in China: Prevalence, Risk Factors, Complications, Pregnancy and Perinatal Outcomes. PLoS ONE, 9(6), e100180. http://doi.org/10.1371/journal.pone.0100180
- Khan KS, Wojdyla D, Say L, Gulmezoglu M, Van Look PF. WHO analysis of causes of maternal death: A systematic review. Lancet 2006; 367:1066-74.
- Salam R. A., Das, J. K., Ali, A., Bhuamik, S., and Lassi, Z.S. (2015). Diagnosis and management of preeclampsia in community settings in low and middle-income countries. Journal of Family Med Prim Care, 4(4), 501–506. http://doi.org/10.4103/2249-4863.174265
- MacDorman, M., Declercq, E., Cabral, H., Morton, C., Is the United States Maternal Mortality Rate Increasing? Disentangling trends from measurement issues: Short title: U.S. Maternal Mortality Trends. Journal of Obstetrics and Gynecology. September, 2016.
- Center for Disease Control Pregnancy Mortality Surveillance System: https://www.cdc.gov/reproductivehealth/maternal-mortality/pregnancy-mortality-surveillance-system.htm
- Racial Disparities Persist in Maternal Morbidity, Mortality and Infant Health: https://www.ajmc.com/view/racial-disparities-persist-in-maternal-morbidity-mortality-and-infant-health