The FDA endorsed three types of tests for diagnosing COVID-19 — PCR, molecular/antigen and antibody/serology. There are some new diagnostic tests available with different methods and benefits at Code 1 Supply!
Serology/Antibody Tests – Tests that detect antibodies (e.g., IgM, IgG) to the SARS-CoV-2 virus. Serology/antibody tests cannot be used to diagnose a current infection, but can confirm a current or past infection. Surveillance testing with these types of tests is popular due to the reduced cost of the tests.
Commercially manufactured antibody tests check for SARS-CoV-2 antibodies in individuals and are available through healthcare providers and commercial laboratories. CDC is evaluating the performance of these tests in collaboration with the following federal organizations:
Biomedical Advanced Research and Development Authority
Food and Drug Administration (FDA)
National Institutes of Health
Department of Defense
White House Office of Science and Technology Policy
Results from the initial federal evaluation are included in FDA’s EUA Authorized Serology Test Performance external icon and will be updated as more tests are evaluated.
Diagnostic Tests – Tests that detect parts of the SARS-CoV-2 virus and can be used to diagnose infection with the SARS-CoV-2 virus. These include molecular tests and antigen tests.
– Rapid test kits for COVID-19, point-of-care diagnostic test kits use a mucus sample from the nose/throat or blood but can be analyzed at the doctor’s office or clinic where the sample is collected, and results may be available in minutes. These may be molecular or antigen tests.
– At-home sample collection devices are prescribed by a doctor but allow the patient to collect the sample at home and send it directly to the laboratory for evaluation.
– Saliva COVID-19 tests allow a patient to spit into a tube rather than get their nose or throat swabbed. Saliva tests may be more comfortable for some people and may be safer for health care workers who can be farther away during the sample collection.
The FDA issued the emergency use authorization (EUA) for some Coronavirus diagnostic devices, like rapid on-site testing kits that are listed here.
Code 1 Supply offers a variety of SARS-CoV-2 rapid test kits in our catalog, but they are all designed for professional use or for research purposes. As you probably know, all COVID-19 rapid tests are not approved by the FDA, some are only allowed for use in the Emergency Use Authorization procedure.