RapCov™ Rapid COVID-19 Test
ADVAITE Inc. is actively developing and commercializing novel, point-of-care diagnostics to help combat the COVID-19 pandemic. These products include a lateral flow immunoassay to detect IgG antibodies in fingerstick whole blood called the RapCov™ Rapid COVID-19 Test (https://www.rapcov.com), and a Point-of-Care based neutralization assay for COVID-19.
U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for emergency use of RapCov Rapid COVID-19 Test (EUA # 202686, issued on 1/11/2021).
RapCov™ Rapid COVID-19 Test is a lateral flow immunoassay intended for qualitative detection of IgG antibodies to SARS-CoV-2 in human fingerstick whole blood specimens. The product is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
Testing of fingerstick whole blood specimens is limited to laboratories certified under CLIA, that meet the requirements to perform high, moderate or waived complexity tests. Testing of fingerstick whole blood specimens is authorized for use at the POC, i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
- This test has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for detecting the presence of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
- The emergency use of this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Specific Public Health and Medical Uses of Rapcov™ Rapid COVID-19 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:
- 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.
- 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.
- 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:
- 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.
- 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.