![]() The serology tests were tested at the Frederick National Laboratory for Cancer Research (FNLCR), a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) or by the Hemostasis Laboratory Branch, Division of Blood Disorders, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention (CDC). We may limit or otherwise restrict your access to the API in line with our Terms of Service About this testing program Introduction Always speak to your health provider about the risks and benefits of FDA-regulated products. Key Factsĭo not rely on openFDA to make decisions regarding medical care. Moreover, studies are underway to address questions that will better inform the appropriate use of these tests, such as whether the presence of antibodies conveys a level of immunity that would prevent or reduce the severity of re-infection as well as the duration for which immunity lasts. However, to use serology tests properly, it is important to understand their performance characteristics and limitations. In addition, these test results can aid in determining who may donate a part of their blood called convalescent plasma, which may serve as a possible treatment for those who are seriously ill from COVID-19. ![]() Serology tests could play a role in the fight against COVID-19 by helping healthcare professionals identify individuals who may have developed an immune response to SARS-CoV-2. This limits the test’s effectiveness for diagnosing COVID-19, and this is one reason serology tests should not be used as the sole basis to diagnose COVID-19. ![]() In the early days of an infection when the body’s immune response is still building, antibodies may not be detected. In other words, the tests detect the body’s immune response to the infection caused by the virus rather than detecting the virus itself. Serology tests detect the presence of antibodies in the blood when the body is responding to a specific infection, like COVID-19. Independent Evaluations of COVID-19 Serological Tests
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