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先兆子痫 (PE) 等相关疾病，这是造成孕产妇死亡的第二大原因，全球范围内有 63,000 名孕产妇死亡，但尽管如此，仍无法准确确定。预测谁可能患上早泄，这会导致准妈妈们感到焦虑，并让她们和她们的孩子处于危险之中。国民医疗服务体系（NHS）因监测被错误地指定为高危妊娠的孕妇以及对妇女进行紧急干预而产生了本可以避免的成本。该项目建立在研究的基础上，该研究表明，测量唾液中一种叫做尿酸（SUA）的化学物质的浓度可以预测哪位准妈妈会患上高血压。过去十年，摩根创新技术 (MIAT) 结合使用赠款资金和自有收入来：\*开发化学物质，以便 SUA 在试纸上引起可测量的颜色变化，与其浓度成正比\*开发比典型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 浓度与孕妇患高血压疾病的可能性联系起来我们将这项新技术称为 Salurate。目前被定义为高血压高风险的患者需要到额外的诊所进行定期血压和尿蛋白测量，但这种监测并不能有效地识别可能面临即将发生肺栓塞等并发症的风险，而 Salurate 可以更准确地识别这些女性。一个女性可以在家使用的非侵入性检测，通过更准确、更早地识别女性，真正需要的女性可以获得她们需要的针对性治疗。我们这个项目的目标是：1.最大化采样的性能并最​​小化对环境的影响。设备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.制作技术文件汇编以供监管部门批准（UKCA标记）我们计划在六年内试点推出Salurate最终，我们的目标是每年为 NHS 节省 2200 万英镑，并通过减少不便的就诊次数和更准确地识别需要进一步干预的女性来改善患者的治疗效果。