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

没有容易获得的具有足够敏感性和特异性的COVID-19/SARS-CoV-2抗体检测。这妨碍了诊断、接触者追踪和政策决定。我们已经开始开发两种靶向质谱抗体检测方法，用于大规模检测和疫苗开发。这些唾液和血浆检测可快速扩展、自动化，可在多个仪器、制造商和实验室之间转移和标准化，提供可实现的100,000次/天检测能力。据我们所知，这是首次针对SARS-CoV-2抗体的靶向质谱检测。该检测是对其他技术平台（免疫测定、即时检测）的补充，因为它使用一套不同的消耗品、仪器、实验室和具有不同技能的科学家。根据英国政府的检测战略支柱3和支柱5，这扩大了英国的抗体检测能力，同时在相同的成本范围内提供更准确的结果。与现有检测方法相比，该检测方法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。除了通常测量的元素（IgM和IgG抗体）外，该测试还测量与中和抗体水平（赋予对疾病的保护）具有更强相关性的元素。结果显示存在多少抗体，而不是二元（阳性/阴性）读数，如果出现抗体浓度与授予的免疫程度相关，这可能变得特别重要。由于唾液样本可以在家中收集，因此该测试中使用的唾液样本简化并拓宽了抗体测试的途径。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，今年秋天在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。Innovate UK的资金将使我们能够根据已发布的目标产品概况验证我们的差异化抗体测试，并与英国公共卫生部和疫苗开发商合作，确保采用这种测试。一旦建立了这种测试，它就可以很容易地适应即将到来的冬季和未来爆发的突变SARS-COV-2或其他病毒。

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.