A rapidly scalable, differentiated COVID-19 antibody/immunity test for mass-testing: proof of concept.

我们的创新是开发了一种新的新冠肺炎/SARS-CoV-2人类抗体检测免疫力的测试方法。该测试可快速扩展，高度自动化，可以很容易地在多个仪器、制造商和实验室之间传输和标准化。与现有检测方法相比，该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。据我们所知，这是第一次针对SARS-CoV-2免疫的靶向质谱学测试。由于使用了不同的消耗品、仪器、实验室和具有不同技能的科学家，该测试也是对现有的护理点和未来的免疫分析的补充。这扩大了英国政府测试策略支柱3和5下的免疫测试能力。我们的愿景是该测试在英国和美国的疫苗开发和大规模测试中的应用，该测试于今年夏天在几个中央实验室推出，目前大规模聚合酶链式反应测试是如何进行的。该项目的主要目标包括在我们的一个实验室实施这项测试，并使用确认的新冠肺炎血液样本评估其诊断准确性和可靠性。这将使我们能够与英国公共卫生(_PHE_)或创新新诊断基金会(FIND)合作，在采用大规模测试之前，在更大的样本队列中评估该测试的性能，包括无症状和轻微症状的病例。该项目的重点是证明我们的方法能够量化人类SARS-CoV-2抗体水平，并在最初的血液样本队列中满足诊断和技术性能指标。一旦建立了该测试，它就可以很容易地适应未来爆发的其他抗原/冠状病毒。由于自动化程度高，这项测试的成本在扩展后显著降低，这意味着它非常适合具有成本效益的大规模测试。我们还将调整这一平台，以开发其他疾病领域的其他临床测试。

Our innovation is the development of a new test for COVID-19/SARS-CoV-2 human antibodies to detect immunity. The test is rapidly scalable, highly automated, can be readily transferred and standardised across multiple instruments, manufacturers and laboratories. It has high inherent specificity and sensitivity in contrast to existing tests, reducing the false positive and false negative rate. To our knowledge, this is the first targeted mass spectrometry test for SARS-CoV-2 immunity.The test is also complementary to existing point-of-care and future immunoassays as it uses different set of consumables, instrumentation, laboratories and scientists with different skillsets. This expands the UK's immunity testing capacity under UK government's testing strategy Pillar 3 and 5\.Our vision is the test's application to vaccine development and mass-testing in the UK and US, rolled out this summer from several central laboratories which is how mass PCR-testing is conducted currently.The key objectives of the project include implementing this test in one of our laboratories and assessing its diagnostic accuracy and reliability using confirmed COVID-19 blood samples. This would enable us to work with Public Health England (_PHE_) or Innovative New Diagnostics foundation (FIND) to assess the performance of this test in a larger cohort of samples, including asymptomatic and mildly symptomatic cases, ahead of adoption for mass-testing.The focus of this project is to demonstrate our method is capable of quantifying human SARS-CoV-2 antibody levels and meets diagnostic and technical performance metrics in the initial cohort of blood samples.Once this test is set up, it can be readily adapted to other antigens/coronaviruses for future outbreaks. Due to the high level of automation the costs of this test reduce significantly upon scaling, meaning it is well suited to cost-effective mass testing. We will also adapt this platform to develop other clinical tests in other disease areas.