On September 29th,2020, the SARS-CoV-2 antigen rapid test kit (fluorescence immunochromatography) independently developed and manufactured by Biohit Healthcare (Hefei) Co., Ltd. passed the CE certification. This is also the world's first novel coronavirus blood antigen rapid test product with EU market access qualification. On October 1st, this product has also entered the FDA EUA review process.
The advantages of SARS-CoV-2 blood antigen rapid test are:
1. The operation is simple, the results can be read in 15 minutes, which is suitable for various novel coronavirus detection scenarios.
2. The sample source of blood is stable, which can avoid the deviation of test results caused by sampling problems，and the test results are more reliable.
3. The SARS-CoV-2 antigen rapid test kit (fluorescence immunochromatography) has a sensitivity of 96.8% and a specificity of 98.9%.
The launch of this product provides an accurate and convenient method for the detection of novel coronavirus.
On September 29th, 2020, two other novel coronavirus products from Biohit, SARS-CoV-2 IgM/IgG antibody test kit (colloidal gold method) and SARS-CoV-2 antigen quantitative assay kit (enzyme-linked immunoassay) also obtained the Australian TGA Certification.