The FDA has granted an emergency use authorization to the Cellex qSARS-CoV-2 IgG/IgM Rapid Test for the detection of antibodies in patients suspected to have COVID-19 exposure.
The test, which is a collaborative effort between Cellex Inc and the Mayo Clinic, can be used to determine if a person had been infected by the coronavirus and then recovered, which could indicate immunity to the virus.
The test detects IgM and IgG antibodies against SARS-CoV-2 in serum and plasma blood specimens, and venous blood samples collected from individuals suspected of COVID-19, the FDA explained.
“Results are for the detection of SARS-CoV-2 antibodies, IgM and IgG that are generated as part of the human immune response to the virus. IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection.”Source: FDA
The Mayo Clinic has said the test could be ready to go on Monday Apr 6, according to MPR News.
“The tests would help public health officials understand the scope of the outbreak and identify people who could safely be in public to help with relief efforts. They would also help in an effort to treat critical COVID-19 patients with plasma from individuals who have recovered.Source: MPR News