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The first innovative blood antigen test method for novel coronavirus was approved

CreateDate:2020-09-02

The SARS-CoV-2 antigen quantitative assay kit (enzyme-linked immunoassay) independently developed and produced by Biohit Healthcare (Hefei) Co., Ltd. passed the EU CE certification on June 12th and was approved by Brazil ANVISA on August 31st.This is also the world's first novel coronavirus blood antigen quantitative test kit approved by the government.



The advantages of quantitative blood antigen testing are:

1.The result of quantitative blood test can represent the viral load, and because the sample source is stable, the test result can indicate the status ofinfection.

2.The content of antigen and antibody in serum is inversely related. Combineddetection of antigen and antibody in blood can verify each other at different stages, providing complete serological evidence for the diagnosis of COVID-19.

3.The SARS-CoV-2 antigen quantitative assay kit (enzyme-linked immunoassay) has a sensitivity of 95% and a specificity of 100%.

In a recent article on blood antigens in COVID-19 patients published by Harvard University Medical School, it also proved that compared with viral RNA, the measurement of blood viral antigens and immunoglobulins can provide more accurate and timely indicators of disease progression and recovery. It can avoid the false positive and false negative problems of nucleic acid testing, which is a new standard for the diagnosis and treatment of the novel coronavirus.(Serial Profiling of SARS-CoV-2 Antigens and Antibodies in COVID-19 Patient Plasma


In order to serve the needs of rapid detection, the company's rapid antigen detection products will also be launched soon, providing new solutions for the diagnosis and prevention of new crowns.


必欧瀚生物技术(合肥)有限公司自主研发生产的SARS-CoV-2抗原定量测定试剂盒(酶联免疫法)612日通过欧盟CE认证,831日获批巴西ANVISA。这也是世界上首个经过政府审批的新冠病毒血液抗原定量检测试剂盒。


定量血液抗原检测的优点是:

  1. 1.  血液定量检测的结果可代表病毒载量,同时因样本来源稳定,检测结果可表示感染的状态。
  2. 2.  抗原抗体在血清中的含量呈反比关系,血液中抗原抗体联合检测,可在不同阶段互相验证,为COVID-19的诊断提供完整的血清学证据。
  3. 3.  SARS-CoV-2抗原定量测定试剂盒(酶联免疫法)检测敏感性95%,特异性100%

哈佛大学医学院在近期发表的关于COVID-19患者血液抗原的文章中,也证明了与病毒RNA相比,血液病毒抗原和免疫球蛋白的测量可以提供更准确和及时的疾病进展和恢复指标。可避免核酸检测的假阳性和假阴性问题,是新冠病毒诊疗新的标准。(Serial Profiling of SARS-CoV-2 Antigens and Antibodies in COVID-19 Patient Plasma


为服务于快速检测的需要,公司的抗原快检产品也即将上市,为新冠诊断和预防提供新的解决方案。