Clinical Trial Data
Shanghai LionRun Clinical Trial Data.
Diagnostic Kit for IgM/IgG Antibody of SARS-CoV-2(Colloidal Gold Immunochromatography)
In order to test the detection sensitivity and specificity of this test, blood samples were collected from COVID-19 patients from multiple Chinesehospitals and Chinese CDC laboratories. The tests were done separately at eachsite. A total of 370 cases were tested: 188(positive) clinically confirmed (including PCR test) SARS-CoV-2-infected patients and 182 non- SARS-CoV-2-infected patients (negative). The testing results were summarized in the table below:
This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA) in accordance with their latest press release authorizing the sale of covid19 testing commercial companies without prior approval. Post sale approval will be conducted by the FDA. Test results and Clinical Trial Data from China is available on this website.