Preeclampsia is a well known condition, affecting around 6% of all pregnancies. It is typically characterised by proteinuria and high blood pressure, but some with the condition have no symptoms and progression can be unpredictable. It can pose significant risks to both the mother and the baby if left untreated, with many currently available tests requiring blood draws and lengthy lab analysis.
Lumella is a new point-of-care risk assessment tool, with digital results in 10 minutes using only a single drop of blood. Multiple hospitals are scheduled to trial Lumella in the UK this year.
Introducing Lumella
Lumella represents a significant development in PE testing, offering a non-invasive and accurate method for preeclampsia screening. Lumella uses the novel biomarker, GlyFN, demonstrating excellent outcomes when compared with other available biomarker tests, including PlGF, with a specificity of 92.8% and sensitivity of 98.5% 1. GlyFN levels are significantly elevated even as early as the first trimester in patients with preeclampsia.
How Lumella Works
The Lumella test can be taken and analysed entirely by bedside. Using a handheld digital reader included in the test kit, the simple 4-step process generates a ‘normal’ ‘positive’ or ‘high positive’ result in just 10 minutes. A high positive result indicates there is a high risk of delivery within 14 days, as well as other severe complications such as HELPP syndrome.
The Benefits of Lumella
High accuracy when compared to other available tests
Quick and simple 4-step testing procedure
No specialised lab equipment, centrifugation, or cold storage required
Cost and time effective - reduces unnecessary admissions
Minimally invasive - only a single drop of blood required
All necessary equipment - such as lancet, swab, reader, and cartridges - are included in the kit
Supported by an ever-growing library of evidence
Click to read the studies
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
Click here to learn more or book a meeting with a Lumella expert.
Text and figures references:
BJOG Glycosylated fibronectin point-of-care test for diagnosis of preeclampsia in a low-resource setting: a prospective Southeast Asia population study- 2020.10.1111/1471-0528.16323
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
Craig Saffer, Gayle Olson, Kim A. Boggess, Richard Beyerlein, Charles Eubank, Baha M. Sibai. Determination of placental growth factor (PlGF) levels in healthy pregnant women without signs or symptoms of preeclampsia, Pregnancy Hypertension: An International Journal of Women’s Cardiovascular Health. Volume 3, Issue 2, 2013. Pages 124-132. ISSN 2210-7789