COVID-19 IgG/IgM Rapid Test
FDA Emergency Use Authorized
The COVID-19 IgG/IgM Rapid Test is a lateral flow immunochromatographic assay for the detection of SARS-CoV-2 antibodies in venous whole blood, serum, or plasma. The COVID-19 IgG/IgM Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
A positive test result for COVID-19 IgG/IgM indicates that antibodies to SARS-CoV-2 were detected, and the individual has potentially been exposed to SARS-CoV-2. Antibodies to SARS-CoV-2 are generally detectable in blood several days following infection. Individuals may have detectable virus present for several weeks following seroconversion. A positive result can indicate recent or past infection but does not exclude recently infected patients who are still contagious. It is unknown how long antibodies to SARS-CoV-2 will remain present in the body after infection and if they confer immunity to infection. Incorrect assumptions of immunity may lead to premature discontinuation of physical distancing requirements and increase the risk of infection for individuals, their households, and the public. False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes. The COVID-19 IgG/IgM Rapid Test has been designed to minimize the likelihood of false positive test results. However, in the event of a false positive result, risks to individuals could include the following: a recommendation for isolation of the individual, monitoring of household or other close contacts for symptoms, isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 individuals, limits in the ability to work, the delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects.
A negative test result with this test means that SARS-CoV-2 specific antibodies were not present in the specimen above the limit of detection. However, patients tested early after infection may not have detectable antibodies despite active infection; in addition, it is not certain that all infected patients will develop a detectable antibody response to SARS-CoV2 infection. A negative result should not be used to rule out infection. Direct testing of SARS-CoV-2 should be performed if acute infection is suspected. Risks to an individual resulting from a false negative result include: restriction of activities deemed acceptable for individuals with evidence of an antibody response to SARS-CoV-2, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events.