For the first time, the FDA has authorized a new coronavirus test that detects antibodies in the blood instead of sampling viruses from the nose or throat with swabs,media reported. While the antibody approach means that the test will have limitations, it is an important tool to help deal with pandemics. The test was carried out by the biotech company Cellex.
Health care providers must draw blood from a patient’s veins to be tested, and only in a certified laboratory, such as the doctor’s office. The test results take about 15 to 20 minutes to get.
When a person is first infected with the virus, their immune system begins to produce antibodies against the virus. Check for someone to have a new coronavirus, and specific antibodies are good evidence that they are infected. However, the body does not immediately begin to produce these substances, and they may not appear until the end of someone’s disease. As a result, antibody-based tests can tell doctors whether someone has been infected with the new coronary virus, but it may not be so good if the patient is now infected with the test.
Still, the FDA’s authorization shows that the agency believes the benefits of the test outweigh the risks. “We have reason to believe that your product may be effective in diagnosing new coronary viruses,” the FDA wrote. “The letter authorizes the use of the test for emergency purposes.
The FDA has allowed some companies to test antibodies to the new coronary virus without formal authorization. However, if these companies are not approved, they cannot claim that their tests can diagnose the disease.
Even if antibody testing is not a good diagnosis, it can play a crucial role in responding to the new coronary pandemic. They will help determine who is sick — whether they have obvious symptoms — so who may have enough immunity to the virus to move safely around the world normally. They will also help public health officials understand how many people are infected with the new coronavirus. At the moment, dozens of companies in the U.S. are developing antibody tests, and researchers at the U.S. Centers for Disease Control and Prevention (CDC) are developing antibody tests.
Although the United States is now working to strengthen testing for new coronaviruses, it is still difficult to obtain testing. Although the U.S. has conducted more than 1 million tests, the U.S. still lags far behind other countries in its per capita rate. An easy-to-access antibody test gives people who can’t detect it when they’re sick have a chance to know if they’re really infected with the new coronavirus.