Two rapidly scalable, differentiated and validated COVID-19/SARS-CoV-2 antibody tests for mass-testing

两种可快速扩展、差异化且经过验证的 COVID-19/SARS-CoV-2 抗体测试，用于大规模测试

• 批准号: 75594
• 金额: $ 11.3万
• 依托单位: EM SCIENTIFIC LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2020
• 资助国家: 英国
• 起止时间: 2020 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=75594
• 关键词: Two; rapidly; scalable; differentiated; validated

There is no easily accessible COVID-19/SARS-CoV-2 antibody test with adequate sensitivity and specificity. This hampers diagnosis, contact tracing and policy decisions. We have initiated the development of 2 targeted mass spectrometry (MS) antibody tests for mass-testing and vaccine development. These saliva and plasma tests are rapidly scalable, automated, can be transferred and standardised across multiple instruments, manufacturers and laboratories, providing an achievable 100,000 tests/day capacity. To our knowledge, this is the first targeted mass spectrometry test for SARS-CoV-2 antibodies.The test is complementary to other technology platforms (immunoassays, point-of-care tests) as it uses a different set of consumables, instrumentation, laboratories and scientists with different skill sets. This expands the UK's antibody testing capacity under UK government's testing strategy Pillar 3 and 5, whilst delivering more accurate results within the same cost ballpark.The test has high inherent specificity and sensitivity in contrast to existing tests, reducing the false positive and false negative rate. In addition to commonly measured elements (IgM and IgG antibodies), the test also measures elements which have a stronger correlation with neutralising antibody levels (which confer protection from the disease) at the same time. The results show how much of the antibodies are present in contrast to a binary (positive/negative) readout, which may become particularly important if it emerges that antibody concentration correlates with the degree of immunity conferred. Saliva samples utilised in this test simplify and broaden access to antibody tests as these samples can be collected at home.Our vision is the test's application to vaccine development and mass-testing in the UK and US, rolled out this autumn from several central laboratories which is how mass PCR-testing is conducted currently.Innovate UK funding will allow us to validate our differentiated antibody tests to published Target Product Profiles and work with Public Health England and vaccine developers to ensure adoption of this test. Once this test is set up, it can be readily adapted to mutated SARS-COV-2 or different viruses for the upcoming winter season and future outbreaks.

目前尚无易于获得且具有足够敏感性和特异性的 COVID-19/SARS-CoV-2 抗体测试。这阻碍了诊断、接触者追踪和政策决策。我们已开始开发 2 种靶向质谱 (MS) 抗体测试，用于大规模测试和疫苗开发。这些唾液和血浆测试可快速扩展、自动化，可以在多个仪器、制造商和实验室之间转移和标准化，提供可实现的每天 100,000 次测试的能力。据我们所知，这是第一个针对 SARS-CoV-2 抗体的靶向质谱测试。该测试与其他技术平台（免疫测定、即时护理测试）相辅相成，因为它使用不同的消耗品、仪器、实验室和具有不同技能的科学家。这扩大了英国政府检测策略第三支柱和第五支柱下的抗体检测能力，同时在相同的成本范围内提供更准确的结果。与现有检测相比，该检测具有较高的固有特异性和敏感性，降低了假阳性和假阴性率。除了常见的测量元素（IgM 和 IgG 抗体）外，该测试还同时测量与中和抗体水平（赋予疾病保护）有更强相关性的元素。结果显示了与二元（阳性/阴性）读数相比存在多少抗体，如果发现抗体浓度与赋予的免疫力程度相关，这可能变得特别重要。该测试中使用的唾液样本简化并扩大了抗体测试的使用范围，因为这些样本可以在家中收集。我们的愿景是将该测试应用于英国和美国的疫苗开发和大规模测试，今年秋天从几个中心实验室推出，这就是目前进行大规模 PCR 测试的方式。创新英国资助将使我们能够验证我们的差异化抗体测试以发布的目标产品概况，并与英格兰公共卫生部门合作 和疫苗开发商确保这项测试的采用。一旦建立该测试，它就可以很容易地适应突变的 SARS-COV-2 或不同的病毒，以应对即将到来的冬季和未来的爆发。