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

DRW正在销售一种简单、强大的即时核酸诊断平台，称为桑巴舞，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、高性能的检测。第一批桑巴舞检测是针对艾滋病毒的：一项是测量艾滋病毒载量，用于治疗监测，另一项是检测婴儿的艾滋病毒，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4.7亿美元用于艾滋病毒诊断采购。为了满足这一需求，DRW必须自动化其测试盒制造，以允许每年150万次测试的生产规模。DRW提议并申请资金，用于开发适合高速组装和100%检测的关键、具有挑战性的生产工艺，为发达国家和发展中国家市场生产桑巴舞测试。拟议的项目将进一步取得积极成果的概念开发与支持创新英国生产线准备。

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.