The primary application of antibody testing, also known as serology testing, is the identification of individuals who have previously been infected with SARS-CoV-2. This knowledge can be used to guide epidemiology and seroprevalence studies, as well as facilitate contact tracing. Some individuals infected with the virus never experienced any major symptoms, which makes antibody testing one of the only methods capable of identifying asymptomatic cases.Additionally, testing provides valuable information on the body’s immune response to the disease in people with different medical histories and conditions. These statistics can aid clinicians and researchers in vaccine development.
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The Fulgent COVID-19 IgM/IgG DR Test is a solid phase immunochromatographic assay for the rapid, qualitative, and differential detection of human IgG and IgM antibodies against SARS-Cov-2 from whole blood, plasma, or serum samples.
The presence of these antibodies is indicative of an adaptive immune response to COVID-19, indicating recent or prior infection. The test uses anti-human IgM and IgG antibodies immobilized on separate nitrocellulose membrane strips to capture and detect antibodies against COVID-19 antigens. IgM antibodies are produced during the early phase of infection (first few days), whereas IgG antibodies are typically detectable during the active, late, and recovery phase of infection (7-10 days post-infection). Fulgent’s Antibody Test screens for both markers to maximize the detection of antibodies against SARS-CoV-2.
* This test has not been cleared or approved by the FDA. Fulgent’s laboratory is regulated under CLIA and is qualified to perform high-complexity testing for investigational or research purposes. This test should not be used as a diagnostic test. Since systematic and technical factors can affect the accuracy of testing, the results of testing should always be interpreted in the context of clinical and familial data.
This test is only valid for the detection of the anti-SARS-CoV-2 IgM&IgG antibody. Efforts have been made in the design of this test to minimize the chances of a false positive result due to the presence of other infectious agents, but this cannot be ruled out. False negative results may occur if the antibody is not present in the tested specimen or is present at a very low level.
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