Point-of-care (POC), rapid POC, and “at home” COVID-19 tests are available for testing at or near the location where the specimen is collected with test results available within minutes. These tests are FDA approved for EUA and can be molecular, antigen, or antibody (serology) type of tests. Many of the rapid POC viral antigen tests use LFIA technology to detect the presence of viral proteins. Rapid POC viral antigen tests have several advantages in that they are inexpensive with results as fast as 15 minutes, easy to perform outside of hospital labs, and simple to interpret.
The FDA has also given EUA approval for several at-home self-testing COVID-19 tests which are usually inexpensive, easy to perform, and can produce a rapid test result within 10-15 minutes. Most at-home self-testing assays use the LFIA technique to measure viral antigens. The sensitivity and specificity of POC, rapid POC, and at-home tests can vary depending on whether an individual is symptomatic or asymptomatic. Typically, the sensitivity of these tests is about 30-40% lower compared to RT-PCR tests and could produce an increased risk of false-negative results especially in those with a low COVID-19 viral load.
Currently, the FDA has approved for EUA usage approximately 387 COVID-19 tests. While a majority of these approved tests are molecular diagnostic-based tests, several are also antigen type and antibody or serology type tests. The FDA and CDC do not endorse any one test over the other but do publish a listing of each type of test with links for more test details. Some of these approved tests include POC, rapid POC, and at-home self-testing assays. The FDA and CDC frequently update the COVID-19 approved test lists.
