FDA approves the first COVID-19 antigen test for emergency use

The number of COVID-19 cases is rasing day by day, accompanying the rise in mortality. Therefore, it is becoming increasingly important for us to diagnose the disease as quickly as possible. While current tests are to be time-consuming, a new test has been approved by the FDA. The test has just got its emergency use authorization by the FDA. This is the third test approved by the FDA for helping diagnose the disease.

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The test, developed by the Quidel Corporation, works based on detecting the antigens present on the virus. The test is said to quickly detect the proteins which may be on or within the virus on the samples collected from nasal swabs. The tests can only be carried out in CLIA approved high and complex laboratories. While we should also see there are two other approved tests dor COVID-19, each with its own significance.

The first being the conventional PCR, which is helping us diagnose the infection with the help of its genetic material. Although the test is known to have higher accuracy, it comes with a serious disadvantage. The tests costume a lot of time, which is not compatible when the number of cases is on the higher side. The second test includes the screening for antibodies against the virus, which helps us to identify the recovered individuals from the infection. This is not used in the case to screen active infection in a population. The new and third test is designed in such a way it is able to detect the antigens present in the virus rapidly. The test is so rapid that we can obtain the results in minutes.

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However, we should also see that antigen tests are not able to detect all active infections. This is because the test is not as sensitive as the PCR. This implies that tests can give highly accurate positive results. But on the other hand, it can also yield a lot of false negatives. Therefore, these negatives need a PCR backup to confirm if it is negative. Nevertheless, we can see these tests are economical when compared to conventional PCR and help in real-time diagnosis. The FDA said that it is the first authorized antigen test, and many more can follow in the future. It also further added that antigen tests could play a crucial role in fighting off COVID-19. With the FDA extending its full support on novel tests, we can expect many more tests to receive emergency use authorization in the future.

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Source: FDA

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