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FDA approves a 20-minute home test for Corona


 

The US Food and Drug Administration has granted emergency permission for the first coronavirus test that can be performed entirely at home, and according to the administration’s official website, other tests require a prescription or sending test samples to the laboratory to obtain the results, but the home test for Corona developed by the Australian company Ellume It is sold without a prescription and produces results that can be read at home.


"Today's mandate is a milestone in diagnostic tests for Coronavirus," said Food and Drug Administration Commissioner Dr. Stephen Hahn in a statement. By allowing the test to be performed for non-prescription use, the FDA allows it to be sold in places like drug stores, where the patient can Buy it, take a test, and see its results in less than 20 minutes.



The first test from FDA to diagnose Corona


The FDA said the test uses a analyzer that connects to a software application on a smartphone to help users take the test and interpret the results.

The Food and Drug Administration said that the Ellume test is an antigen test that "correctly identified 96% of positive samples and 100% of negative samples in symptomatic individuals, indicating that the test correctly identified 91% of positive samples and 96% of negative samples in people who do not have them." Syndrome.

Today's announcement of the first diagnostic test for Corona at home comes after the licensing last month of the first Corona test, with a prescription for home use, and the announcement last week of the first non-prescription test system, where the laboratory processes a self-collected sample.

The US Food and Drug Administration (FDA) has allowed more than 225 diagnostic tests for Corona since the beginning of the epidemic, including more than 25 tests that allow samples to be collected from the home, which are then sent to the laboratory for testing, but the Ellume home test is the first test. It can be used entirely at home without a prescription.


The Ellume home test uses a medium-sized nasal swab to detect certain virus proteins known as antigens.

The US Food and Drug Administration continues to work with test developers to expand access to the Corona test, and support further development of Corona tests that can be used entirely at home.


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