Development of a SARS-COV-2 ELISA In Vitro Diagnostic Immuno-Assay

准确追踪COVID-19病毒传播的广泛检测将严重依赖准确的血清学检测，这种检测能够间接检测免疫系统对SARS-COV-2产生的抗体的存在。这种方法旨在识别感染该病毒并对SARS-COV-2产生免疫力的患者。大多数血清学（抗体捕获）测试分为两个阵营：定性的是/否快速横向流动护理点测试和基于实验室的定量ELISA测试，该测试依赖于准确测量患者血清样本中抗体与病毒颗粒表面独特结构蛋白之间复合物的形成。ELISA检测仍然是一种简单但功能强大、可靠且值得信赖的传染病诊断工具。目前对快速诊断（POC）测试的需求并没有使基于实验室的可靠、可扩展测试的需求变得多余。基于实验室的检测是大规模监测研究的首选方法。例如，ELISA是每天测试数百个样品的理想选择，并且在相同的简单设备上测试少至1至4个测试也是通用的。此外，POC血清学检测往往不太可靠和不太敏感，因此需要持续进行确认性检测。很明显，在Kalon，我们有一个经过验证和建立的平台和技术专长，可以在此基础上建立针对导致Covid-19的病毒SARS-CoV2的免疫测定法。

Widespread testing to accurately track the spread of the COVID-19 virus will critically depends on accurate serological tests that can indirectly detect the presence of antibodies produced by the immune system in response to SARS-COV-2\. This approach is intended to identify patients who contracted the virus and have developed immunity against SARS-COV-2\. Most serological (antibody-capture) tests fall into 2 camps: a qualitative Yes/No rapid lateral flow point-of-care tests and a quantitative lab-based ELISA test that relies on accurately measuring the formation of a complex between the antibodies in the patient serum samples and unique structural proteins on the surface of the virus particle. ELISA assays remain a simple yet powerful, robust and trusted tool for the diagnosis of infectious disease.Current calls for rapid diagnostic (POC) tests does not make the requirement for robust, scalable laboratory-based tests redundant. Laboratory-based tests are the method of choice for large-scale surveillance studies. For example the ELISA is ideal for testing hundreds of samples per day, and is yet versatile to test as few as 1 to 4 tests on the same simple equipment. In addition, POC serological tests have a tendency to be less reliable and less sensitive and therefore there will be an ongoing need for confirmatory testing.It is clear, that at Kalon, we have a proven and established platform and technical expertise on which to build immunoassays for SARS-CoV2, the virus that causes Covid-19\.