Advice

The technology

The technology

The Lumella test (Diabetomics) is a point-of-care blood test used, together with other clinical and laboratory information, to assess the risk of pre-eclampsia in pregnancy. It works by detecting glycosylated fibronectin (GlyFn) in the blood and providing semi-quantitative measurements of the biomarker.

The Lumella test system comprises:

  • a pre-eclampsia test cartridge

  • a test reader that uses reflectance photometry to measure colour changes on a test cartridge

  • accessories needed to do the test including:

    • lot-specific radiofrequency identification (RFID) card with RFID tag

    • single-use lancing device

    • capillary blood collection micropipette

    • vial containing sample buffer

    • alcohol wipe

    • bandage

    • sample transfer pipette.

All accessories are provided with each test kit and do not need to be purchased separately.

The test needs a finger prick blood sample (5 microlitres) and can be done at between 13 and 37 weeks of gestation. To do the test, the test cartridge is inserted into the reader and the diluted blood sample is applied to the cartridge. Test results are then displayed by the reader in 10 minutes. Results can also be printed by connecting the reader to a Bluetooth printer. The test can be transported, stored and done at room temperature.

Innovations

The Lumella test is based on the novel biomarker GlyFn. The company states that compared with other currently used biomarkers (such as soluble fms‑like tyrosine kinase‑1 [sfIT‑1] and placental growth factor [PlGF] or PlGF alone), GlyFn is etiological to pre-eclampsia and maintains a linear progression throughout pregnancy. The company also claims that the test offers improved sensitivity and specificity over standard care tests. This would lead to a reduction in false positives and false negatives. The Lumella test requires a finger prick blood sample (5 microlitres). Other pre-eclampsia tests currently used in the NHS need a phlebotomy blood sample, which can be difficult to collect in some people. The test can also be transported and stored at room temperature. Other tests for pre-eclampsia need to be refrigerated and brought to room temperature before the test can be done. The Lumella test may improve patient experience and allow a more rapid turnaround time for results. The company states that Lumella is currently the only test that can be done within 10 minutes at room temperature.

Current care pathway

Pre-eclampsia is usually diagnosed during routine antenatal appointments. This is based on blood pressure measurements and results of urine protein tests that are recommended at each routine antenatal visit to screen for the condition. The Triage PlGF test and the Elecsys immunoassay sFlt‑1/PlGF ratio is also recommended to help rule out the condition in women presenting with suspected pre-eclampsia between 20 weeks and 34 weeks of pregnancy plus 6 days. If diagnosed with pre-eclampsia, women are usually referred to a specialist in hospital for further tests and more frequent monitoring. Depending on the severity of the condition, some women may be monitored as outpatients while others may need admission to hospital for closer monitoring or to have the condition managed in a critical care setting.

The following publications have been identified as relevant to this care pathway:

Population, setting and intended user

The Lumella test is intended to be used with other clinical and laboratory information to assess the risk of pre-eclampsia during pregnancy, between 13 and 37 weeks. The company states that it can also be used at the bedside in hospitals to monitor patients.

Pre-eclampsia is a potentially serious condition that affects some pregnant women, usually during the second half of pregnancy (after 20 weeks) or soon after birth. It is characterised by new-onset high blood pressure (hypertension) and new or significant protein in the blood (proteinuria). Other symptoms include headache, visual disturbances, right upper quadrant abdominal (epigastric) pain, oedema (swelling of the hands, face or feet) and oliguria (low output of urine). If undiagnosed, pre-eclampsia can lead to complications such as eclampsia, HELLP syndrome (haemolysis, elevated liver enzymes and low platelets), stroke, organ dysfunction and blood clotting disorders. Women who develop pre-eclampsia during pregnancy may be at greater risk of cardiovascular disease in later life. Women with pre-eclampsia may have a higher risk of placental abruption (a condition in which the placenta separates from the inner wall of the uterus before the baby is born). Pre-eclampsia can also affect the baby, increasing the risk of fetal growth restriction, low birth weight or preterm birth. In the UK, pre-eclampsia is estimated to affect up to 1 in 25 pregnancies. In the UK, mild pre-eclampsia affects about 6% of pregnancies. Severe cases develop in around 1% to 2% of pregnancies.

The Lumella test is likely to be used in secondary care and will be done by a midwife or obstetrician during routine antenatal appointments.

Costs

Technology costs

Each Lumella test kit costs £50 (excluding VAT) and includes 1 test cartridge and consumables needed to do the test. The reader is supplied free of charge with the first order. The initial purchase contains 10 test cartridges and a reader. The reader is not sold separately. It comes with a 1‑year warranty, and can be replaced free of charge within the warranty period if damage is because of conditions within the warranty limits. The reader also comes with a calibration cartridge.

Costs of standard care

A standard care PlGF‑based test costs around £40 to £60. The Alere (Quidel) PlGF test also requires a reader that is priced at £1,400 (NICE diagnostics guidance on PlGF-based testing to help diagnose suspected pre-eclampsia). There may also be additional costs involved for laboratory instruments and service costs for the Roche Elecsys test. PlGF‑based testing involves a blood draw, which requires a trained clinician to do. There are unlikely to be additional costs for phlebotomy with these tests because blood samples will have already been taken as part of standard clinical assessment.

Resource consequences

Lumella has been launched in the UK but is not currently used in NHS clinical practice. The company states that the Lumella test is cheaper to purchase than standard care tests. Adopting the technology could be resource releasing because it is a point-of-care test that does not need to be done in a central laboratory. The test is simple to do and can be done by midwives during routine antenatal appointments. Some women having standard care tests may need an overnight hospital stay while waiting for test results. The company states that Lumella could reduce hospital stays because test results are available within 15 minutes. There is currently no published evidence to support this claim. NICE diagnostics guidance on PlGF-based testing assumed that 10% of women having assessment for suspected pre-eclampsia using the Elecsys immunoassay sFlt‑1/PlGF ratio will need an overnight stay while waiting for test results. If the Triage PlGF test is used in a near-patient setting in a midwife-led day-case unit it is assumed that no one needs to be admitted overnight while waiting for test results. There are no anticipated practical difficulties or changes in facilities and infrastructure associated with adopting this technology. Training is provided by the company's UK team at no additional cost. The company states that they have 2 training videos and are developing an online training program and certification.