FDA grants Advaite emergency use authorization for RapCov Rapid COVID-19 Test.

The FDA has granted Emergency Use Authorization (EUA) to one of the first U.S.-manufactured serology tests designed by Advaite Inc., an innovative biotech company developing novel point-of-care assays to help with combatting COVID-19. The federal government’s EUA for ADVAITE’s rapid response IgG antibody test will strengthen America’s public health protections against epidemiological threats by facilitating access to cutting-edge medical countermeasures, such as Advaite's RapCov Rapid COVID-19 Test. Advaite is one of only a handful of US manufacturers to receive EUA for a point-of-care serology test. There exists a great need for laboratory assays that measure antibody responses. While serological assays are not well suited to detect acute infections, they support a number of highly relevant public health and medical applications.From a community perspective to limit the spread of infection, the Rapcov test may help in the following practical ways: i. Presence of IgG antibodies on Rapcov test may suggest a non-recent (past) infection as neutralizing antibodies against the COVID-19 virus may be present in the blood. Presence of COVID-19 virus neutralizing IgG antibodies will suggest that the individual is of little concern from a public health perspective and is perhaps unlikely to get infected with COVID-19 virus. Presence of IgG antibodies on Rapcov test will also permit to determine who is immune and who is not. This would be very useful for deploying immune healthcare workers in a strategic manner as to limit the risk of exposure and spread of the virus inadvertently. ii.In cases where nucleic acid amplification assays (RT-PCR) are negative and there is a strong epidemiological link to COVID-19 infection, serology tests (in the acute and convalescent phase) may support diagnosis of COVID-19 disease. iii.Serosurveys are needed to determine the precise rate of infection in an affected area, which is an essential variable to accurately determine the infection fatality rate. Serological surveys can aid investigation of an ongoing outbreak and retrospective assessment of the attack rate or extent of an outbreak. From a medical decision-making perspective the information regarding presence of IgG antibodies in the blood may help save lives in the following ways: i. It may help medical decision making in the treatment of acutely ill hospitalized patients who have CT scan and other clinical findings consistent with COVID-19 disease, but a negative RT-PCR result. In these patients Rapcov test may provide information regarding presence of IgG antibodies to support a diagnosis of COVID-19 infection and facilitate appropriate medical treatments. There is no single ‘Gold Standard’ for the diagnosis of COVID-19 infection. The different diagnostic methodologies provide different information regarding COVID-19 infection and a complete clinical picture is made possible by using information provided by all testing methodologies. ii. Currently there are no specific anti-viral treatments for COVID-19 disease. The RapCov test administered in the communities can identify individuals who mounted strong IgG antibody responses and who could serve as donors for the generation of convalescent serum therapeutics. This serum can be administered for prophylaxis and treatment of COVID-19 infection to save lives.