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

目前还没有容易获得的具有足够灵敏度和特异性的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2种靶向质谱（MS）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，可在多台仪器、制造商和实验室之间转移和标准化，每天可进行10万次检测。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，即时检测）互补，因为它使用了不同的耗材，仪器，实验室和具有不同技能的科学家。这扩大了英国政府测试战略支柱3和支柱5下的英国抗体测试能力，同时在相同的成本范围内提供更准确的结果。与现有测试相比，该测试具有较高的固有特异性和灵敏度，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（提供疾病保护）同时具有更强相关性的元素。结果显示存在多少抗体，与二元（阳性/阴性）读数相反，如果出现抗体浓度与赋予的免疫力程度相关，则这可能变得特别重要。唾液样本可以在家中采集，简化并扩大了抗体检测的范围。我们的愿景是将该检测应用于英国和美国的疫苗开发和大规模检测，今年秋天，几个中心实验室推出了大规模PCR-Innovate UK的资金将使我们能够验证我们的差异化抗体测试，以发布目标产品概况，与英国公共卫生部和疫苗开发人员合作，确保采用这种测试。一旦该测试建立，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疫情。

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.