Summary

Advice

The technology described in this briefing is the Lumella test. It is for assessing the risk of pre-eclampsia during pregnancy.
The innovative aspects are that it is based on a novel biomarker (glycosylated fibronectin) that may have improved sensitivity and specificity compared with standard care. The test requires a finger prick blood sample (5 microlitres) and can be done in around 10 minutes.
The intended place in therapy would be as an alternative to the placental growth factor (PlGF) test or soluble fms‑like tyrosine kinase‑1 (sFlt‑1)/PlGF ratio test during pregnancy in women presenting with signs and symptoms of pre-eclampsia.
The main points from the evidence summarised in this briefing are from 3 prospective observational studies including a total of 956 pregnant women. They show that Lumella has good diagnostic performance for detecting pre-eclampsia (area under the receiver-operating characteristic curve of 0.99), with a sensitivity of 0.98 and specificity of 0.93, at a glycosylated fibronectin cut-off value of 263 micrograms/ml.
Experts advised that the test could improve result turnaround time and reduce hospital waiting time for people getting tested. This is because the test does not need to be done in a laboratory. All experts agreed that there is currently insufficient evidence to determine the test accuracy compared with standard care in the UK.
Key uncertainties around the evidence or technology are that the studies included recommended biomarkers sFlt‑1 and PlGF or PlGF alone. But the immunoassays used in the studies are not the commercial assays currently used in the NHS (Triage PlGF test and Elecsys immunoassay sFlt‑1/PlGF ratio).
The cost of a Lumella test kit is £50 per unit (excluding VAT). A standard care PlGF‑based test costs around £40 to £60.