How it Works
How a health care worker can conduct a 10-15 rapid response test at point-of-test using a home test kit.
In order to comply with FDA guidelines, until approved by EUA, this test must be conducted at point-of-test by health care worker and not by patient.
We did 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 Chinese hospitals and Chinese CDC laboratories. The tests were done separately at each site. 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).