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

DRW正在推销一种简单、强大的即时核酸诊断平台SAMBA，该平台允许在发展中国家偏远、资源有限的环境和发达国家初级保健环境中进行复杂、高性能的检测。首批SAMBA检测是针对艾滋病毒的：一种用于测量艾滋病毒载量以进行治疗监测，另一种用于检测婴儿体内的艾滋病毒，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婴儿早期诊断，2017-2019年期间将有4.7亿美元用于艾滋病毒诊断采购。为了满足这一需求，DRW必须实现测试墨盒制造的自动化，以实现每年150万次测试的生产规模。DRW提议并要求提供资金，用于开发适合高速装配和100%检验的具有挑战性的关键生产工艺，以便为发达国家和发展中国家市场生产SAMBA测试。拟议的项目将进一步推进在英国创新公司为生产线准备工作提供支持下开发的概念的积极成果。

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.