Micronutrient deficiencies during pre- and post-natal stages pose a serious health and economic burden to healthcare providers. The key deficiencies are vitamin B12, D, folate and Iron. Around 57,000 emergency admissions to UK hospitals annually are due to iron deficiency anaemia; the UK prevalence of anaemia is elevated in pregnant women (23%, compared to 8% in the general population). Vitamin B12 deficiency was shown to be present in 26% of UK pregnant women. Testing for micronutrient levels requires samples to be collected and sent to a central lab for testing. Iron and vitamin D lateral flow tests exist on the market, however there is no 'universal' test available that allows testing of multiple micronutrients in parallel. A point-of-care test which is sensitive enough for deficiency assessment is not available for B12 or folate deficiency on the market. Individuals are purchasing micronutrient tests via laboratory companies, however these samples still require testing in a central lab, resulting in a high cost per test and a delay to results. We see a significant opportunity in a universal at-home test, that empowers pregnant and breastfeeding women, delivers immediate results, and links to their healthcare professionals. Single-use point-of-care diagnostics struggle in eco-design with tests predominantly being incinerated or disposed of in land-filll. For example, one traditional lateral flow test (e.g. Covid-19) produces 10g of plastic waste, equating to around 10 tonnes of plastic waste per week in June 2022 (NHS Test and Trace). With an increasing demand for at-home medical diagnostics, combined with a growing public sentiment to reduce plastic waste, this is a crucial time to employ strategic eco-design principles. Hence, this project allows us to build eco-design and circularity into our product, while retaining its ease-of-use and cost-effectiveness. This project builds a new capability in human factor work through subcontractor KD, a design consultancy, together with project partner and potential customer/end-user Pregma. We have already developed a functional prototype; the project aims are to identify and decide critical design elements and potential new business models that maximise product sustainability and impact.

Vitamin B12 deficiency is a significant health concern in the UK, and globally, with deficiency being extremely detrimental to infant, child and adult health. Vitamin B12 is important for brain development, with severe deficiency leading to seizures and permanent brain damage. Infants and the elderly are of significant risk. There are currently \>660,000 newborns born every year in the UK; 25% of which are exclusively breastfed and are at-risk of B12 deficiency. Vitamin B12 deficiency prevalence increases with age with approximately 20% of people older than 65 being deficient in the UK. There is a growing need for a point-of-care B12 deficiency test. In this project we will develop a novel B12 point-of-care test by exploiting engineering biology techniques. Specifically, in this project we will develop a novel lateral flow device capable of identifying non-protein based targets through measurement of reaction activity on a paper system. Commercial lateral flow tests principally use antibodies to detect analytes, and cannot detect non-protein targets that an antibody cannot be generated against. Typically detection of B12 deficiency requires a central lab and expensive equipment. This project will employ the synthetic biology cell-free system and genetic engineering to produce a functional enzyme to enable detection of a B12 deficiency marker in a paper based system.