Two new corona detection tests have been approved by the US Food and Drug Administration (FDA) with urgent procedures. This is the first antigen test that can quickly detect if someone is infected with the new virus and the first diagnostic molecular test performed at home with a saliva sample.
The Sofia 2 SARS Antigen FIA antigen test, which will provide a cheap and fast tool for mass screening of health personnel in principle, has been developed by Quidel Corp’s company California and is based on a sample taken from the nose and the results come out in a few minutes.
Antigen tests are the third test category, in addition to molecular tests (PCR) that detect genetic material and serological tests of antibodies that detect antibodies against the new virus. Antigen tests directly detect whether there are traces of the virus (protein-antigens) in a sample. The FDA plans to approve more antigen tests soon.
These tests are very accurate in detecting Covid-19 infections, but they cannot detect all infections, while they also have a higher rate of false-negative results in relation to the molecular PCR tests that are widely used. Therefore, according to the FDA, the negative results of quick antigen tests may require a confirmation from a molecular test, which is slower and more expensive, but also more Reliable.
Antigen tests, after further improvement, may be used at home in the future, such as pregnancy tests. The FDA said that “antigen tests will play a critical role in the fight against Covid-19.”
The FDA also approved the molecular test at the Rutgers Clinical Genomics Laboratory in New Jersey, the first test that is now approved for home use of saliva samples and will only be prescribed with a prescription. Samples should be mailed to the lab in a specially sealed package (contained in the test “kit”) to be analyzed and then informed of the results.
It was preceded in April by the FDA’s approval of the first home test for coronavirus based on samples taken on their own from their noses and which are also sent for laboratory testing. Saliva tests are even easier to use and “user-friendly” than nose tests.
According to the FDA, which since the beginning of the pandemic has urgently approved more than 80 tests for Covid-19, home tests “provide an additional option for easy, safe and convenient collection of samples, without having to go in the doctor’s office, in the hospital or in another test site”.