Process development, automation and scale-up for SAMBA point-of-care Nucleic Acid test.

SAMBA 护理点核酸测试的流程开发、自动化和放大。

• 批准号: 103540
• 金额: $ 120.81万
• 依托单位: DIAGNOSTICS FOR THE REAL WORLD (EUROPE) LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2017
• 资助国家: 英国
• 起止时间: 2017 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=103540
• 关键词: Process; development; automation; scale; up

DRW is marketing a simple, robust point-of-care nucleic acid diagnostic platform, called SAMBA, which allows complex, high-performance tests to be carried out in remote, resource-limited settings in developing countries and primary care settings in developed countries. The first SAMBA tests are for HIV: one to measure HIV viral load for treatment monitoring and one to detect HIV in infants in order to initiate early treatment. Due to WHO recommendation and international aid funding for viral load monitoring and early infant diagnosis in sub-Saharan Africa, $470 million will be available between 2017-2019 for HIV diagnostic procurement. To meet this demand, DRW must automate its test cartridge manufacture to allow a production scale of 1.5 million tests/annum. DRW proposes and requests funding for developing critical, challenging production processes that are appropriate for high-speed assembly and 100% inspection, to produce SAMBA tests for the developed and developing world market. The proposed project will further progress positive outcomes of concepts developed with support from Innovate UK for Production Line Readiness.

DRW正在营销一种简单、强大的医疗点核酸诊断平台，称为Samba，它允许在发展中国家的偏远、资源有限的环境和发达国家的初级保健环境中进行复杂的高性能测试。第一批Samba检测是针对艾滋病毒的：一项是测量艾滋病毒病毒载量用于治疗监测，另一项是检测婴儿中的艾滋病毒以便开始早期治疗。由于世卫组织的建议和国际援助资金用于撒哈拉以南非洲的病毒载量监测和早期婴儿诊断，2017-2019年期间将有4.7亿美元可用于艾滋病毒诊断采购。为了满足这一需求，DRW必须使其测试盒制造自动化，以实现每年150万次测试的生产规模。DRW建议并请求资金用于开发关键的、具有挑战性的生产工艺，这些工艺适合高速组装和100%检查，以便为发达和发展中的世界市场生产Samba测试。拟议的项目将进一步推动在英国创新为生产线准备工作的支持下开发的概念的积极成果。