Lumella® Test for Assessing Pre-eclampsia Risk UK

Rapid and Accurate Point-of-Care Test
for Assessing
Pre-eclampsia Risk

What is Lumella®?

How does it work?

Lumella® is a rapid point-of-care (POC) test which predicts the risk of pre-eclampsia. Only requiring a single fingerpick of blood, Lumella can be performed on the ward or in a doctor’s surgery, without needing the blood sample to go the lab. As a POC preeclampsia test, Lumella has a sensitivity of 98.5% and specificity of 92.8%. 1

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 1,2,3.

A cost and time effective bedside pre-eclampsia test that reduces risk at the earliest stage.

1-2% of pregnancies will develop the life-threatening condition, eclampsia. Early symptoms of pre-eclampsia are often ambiguous for accurate clinical stratification. Less than 40% of patients who develop PE present with both proteinuria and hypertension 4.

Pre-eclampsia progression is unpredictable, and therefore must be diagnosed as soon as possible to be managed safely with timely and appropriate treatment.

The simple 4-step procedure gives a clear 'normal' 'positive' or 'high positive' result within 10 minutes. A high positive result indicates a high risk of delivery within 14 days as well as other complications such as HELPP syndrome.

Key Benefits

High Accuracy when Compared to other Biomarkers

Cost Effective

Time Efficient true Point-of-Care Test

Simple & Rapid Testing Procedure

Healthcare Professionals Comments

“The Lumella test uses an elegant and convenient handheld device, which we have used in the research setting and have found very easy to use. It also gives results in just 10 minutes.”

Dr. Amarnath Bhide, Consultant & Reader in Fetal Medicine & Obstetrics

Literature and Resources

References

All studies referenced on this page are listed in the document linked here.

For more studies and resources, visit the resources page. You can find this in menu at the top of the page.

IFU

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.

Quick Reference Guide

Literature Summary

FAQs

If the Lumella result is normal, how frequently should the test be repeated?

If the Lumella result is positive, and there is no change in the severity of symptoms, how frequently should the test be repeated?

If the Lumella result is high positive, what actions should be taken?

From what gestational age can Lumella be used?

Why use Lumella over clinical presentation?

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