Quickvue is a lateral flow test, a portable covid test that usually returns results faster than the widely used laboratory based PCR test.
It works by testing nasal swab samples and provides positive or negative results within 10 minutes. The results appear on test strips exposed to nasal swab samples.
The FDA said swab can be collected from people aged 8 and over, but if the children tested are less than 14 years old, it should be collected by adults.
Quidel claimed that the positive results of the test matched the PCR test for 84.8% and the negative results matched the PCR test for 99.1%.
The FDA said that the negative test results of quickvue test do not necessarily exclude the possibility of covid - 19 infection, "and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.
"People who are negative and continue to experience COVID - 19, have a fever, cough and / or shortness of breath, may still have SARS - CoV - 2 infection. Follow up care for doctors or medical staff should be sought."
Not all side flow tests require the use of prescriptions. On December 15, the FDA released the EUA for the first covid test outside the counter at home.
The ellumecovid - 19 family test also uses nasal swab samples to detect covid infection and works with people aged 2 and older.
The FDA said that among people with covid symptoms, the ellume test correctly identified 96% of positive samples and 100% of negative samples. In the asymptomatic population, it collected 91% of positive samples and 96% of negative samples.
Similarly, the FDA said that using the negative results of the test does not necessarily exclude the possibility of covid infection.