Salurate - Validation of salivary uric monitoring for early prediction of hypertensive disorders in pregnancy

Salurate - 唾液尿酸监测对妊娠期高血压疾病早期预测的验证

• 批准号: 10053908
• 金额: $ 151.61万
• 依托单位: MORGAN INNOVATION & TECHNOLOGY LTD
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10053908
• 关键词: Salurate; Validation; salivary; uric; monitoring

Over 10% of pregnant women experience high blood pressure (hypertension) and related conditions such as pre-eclampsia (PE). Untreated PE is the second biggest cause of maternal deaths - 63,000 annually worldwide, but despite this, there is no way of accurately predicting who may develop PE. This causes anxiety for expectant mothers and puts them and their baby at risk. The NHS incurs avoidable costs from monitoring pregnant women who are wrongly assigned as having a high-risk pregnancy, emergency interventions on women with undiagnosed PE and paying compensation when mothers or babies suffer due to undiagnosed hypertensive disorders.This project builds upon research that has shown that measuring the concentration of a chemical called uric acid in saliva (SUA) can predict which expectant mother will develop hypertension. Over the last ten years, Morgan Innovation and Technology (MIAT) have used a mixture of grant funding and own revenues to:\*Develop chemistry so that SUA causes a measurable colour change on a test paper, proportional to its concentration\*Develop a saliva sampling device that is easier to use than a typical pregnancy test\*Develop technology to relate colour change to SUA concentration\*Relate SUA concentration to how likely it is that a pregnant woman will develop hypertensive disordersWe call this novel technology Salurate.Currently patients defined as high risk from hypertension attend extra clinics for regular blood pressure and urinary protein measurement. Yet this monitoring is not effective at identifying women who may be at imminent risk of developing complications such as PE. Salurate can identify these women more accurately, with a non-invasive test that women can use at home. By identifying women more accurately, and earlier, women who really need it can get the targeted treatment they require.Our aims in this project are:1.Maximise performance and minimise environmental impact of sampling device2.Conclude associated software development3.Carry out a clinical study on 4,000 participants to validate the data-learning algorithm from a representative UK population4.Produce a technical file compilation for regulatory approval (UKCA marking)We plan a pilot launch for Salurate within six months of finishing the project. Ultimately, we aim to save the NHS £22m per year and improve patient outcomes by reducing inconvenient clinic attendances and identifying the women who need further interventions more accurately.

超过10%的孕妇患有高血压和相关疾病，如先兆子痫（PE）。未经治疗的PE是孕产妇死亡的第二大原因-全世界每年有63，000人死亡，但尽管如此，没有办法准确预测谁可能患上PE。这会引起孕妇的焦虑，并使她们和她们的婴儿处于危险之中。英国国家医疗服务体系（NHS）对那些被错误地认定为高危妊娠的孕妇进行监测，对未确诊的PE患者进行紧急干预，以及在母亲或婴儿因未确诊的高血压疾病而遭受痛苦时支付赔偿，这些都是可以避免的成本。该项目建立在研究的基础上，研究表明，测量唾液中一种名为尿酸（SUA）的化学物质的浓度可以预测哪些准妈妈会患上高血压。在过去的十年中，摩根创新和技术（MIAT）使用赠款资金和自有收入的混合物：* 发展化学，使SUA在试纸上引起可测量的颜色变化，与其浓度成比例\* 开发一种比典型的妊娠测试更容易使用的唾液采样装置\* 开发将颜色变化与SUA浓度联系起来的技术\* 将SUA浓度与孕妇发生高血压疾病的可能性联系起来我们称之为Salurate。目前，高血压高危患者需要定期到额外的诊所进行血压和尿蛋白检查。测量.然而，这种监测并不能有效地识别可能有发生并发症（如PE）的紧迫风险的妇女。Salurate可以更准确地识别这些女性，女性可以在家中使用非侵入性测试。通过更准确和更早地识别女性，真正需要的女性可以得到他们需要的针对性治疗。我们在这个项目中的目标是：1.最大限度地提高采样设备的性能并最大限度地减少对环境的影响2.完成相关软件开发3.对4，000名参与者进行临床研究，以验证来自英国代表性人群的数据学习算法4.制作技术文件汇编供监管部门批准（UKCA标记）我们计划在项目完成后的六个月内进行Salurate的试点发布。最终，我们的目标是每年为NHS节省2200万英镑，并通过减少不方便的诊所就诊和更准确地确定需要进一步干预的妇女来改善患者的治疗效果。