Advice
Expert comments
Expert comments
Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.
All 3 experts were familiar with similar tests for pre-eclampsia, but none had used this particular technology before.
Level of innovation
One expert said the test was a minor variation to standard care and would be offered as another biomarker test for pre-eclampsia in addition to the 4 already available. Two experts said that the test was novel and of uncertain safety and efficacy. One of these experts said that if the diagnostic accuracy is as described then the test appears to be highly innovative. They added that there are few tests that have a high positive predictive value for pre-eclampsia. Two experts said that the test could replace standard care, if shown to have comparable efficacy. One expert said they were not aware of any other competing technologies and that Lumella is the only glycosylated fibronectin test for pre-eclampsia they are aware of. Two experts noted that other tests are available for pre-eclampsia. One of these experts said that most alternative tests need laboratory testing, but the Quidel Triage placental growth factor (PlGF) test can be done using near-patient testing with results available in 15 minutes.
Potential patient impact
The experts noted that Lumella is a point-of-care test that could offer more rapid turnaround time for test results and quicker triage in suspected pre-eclampsia. One expert highlighted that standard care tests need to be processed in a laboratory and test results can sometimes take several hours. One expert said the test may provide greater reassurance for people because of the high positive predictive value. Women at high risk of or suspected to have pre-eclampsia were identified as people who would particularly benefit from the test. One expert said that the test may also be used to exclude pre-eclampsia in a larger cohort of women with hypertension.
Potential system impact
Two experts said that Lumella could change the current care pathway. One of these experts said the main system benefit is how quickly the test result is returned. They added that this may help to reduce the hospital waiting time for people being tested and even reduce hospital attendance if testing can be done in the community. The expert also noted that finger prick testing is technically easier than phlebotomy and therefore a trained phlebotomist would not be needed to do the test. One expert did not think that the test would change the current pathway that uses PlGF‑based testing. Two experts said the cost of adopting the technology would be similar to standard care. One expert said that the cost of implementing the test would be the same as standard care but cost saving in outcomes may be seen. This is because the test appears to have a higher accuracy and therefore fewer false positive and false negative results. Most of the experts agreed that little to no changes to existing facilities would be needed to adopt the test and minimal training would be needed. One expert said that point-of-care testing approval and maintenance would be needed and could be a barrier to adoption.
General comments
None of the experts were aware of any NHS centres using the test. Two experts said there were no practical or usability issues of the technology. Two experts thought that the test could be done at most or all district general hospitals while 1 said they could not predict this at present. When asked about the size of the eligible population, one expert estimated 50,000 people. One expert estimated between 3% and 5% of 700,000 women per year and another estimated 5% to 7% of pregnant women. One expert said there is no risk of adverse events or harm to patients, while 2 said the risk would be low if the test efficacy is proven. All experts noted that there was insufficient evidence to determine the test accuracy compared with standard care in the UK. One expert said that the accuracy and positive or negative predictive values need to be confirmed. They also said that the available evidence comes from studies with a small sample size and that larger sized studies are needed. One expert noted that a prospective head-to-head comparison with standard care would be needed. One expert also noted the lack of published economic analyses on the technology.