The Food and Drug Administration has granted emergency authorisation to a self-testing kits that can be used at home. It is the first at-home rapid result kit that could detect the presence of SARS-CoV-2 that causes coronavirus.
In a press release FDA revealed that the test -- Lucira COVID-19 All-In-One Test Kit, is a single-use test developed to detect SARS-CoV-2. The kit is authorised for prescription use only. It also uses nasal swab detection and can provide results in a matter of 30 minutes, and at times even less than that. The self-test unit has a light-up display where you would be able to read the results. It is straightforward as the indicators that you see would either be negative or positive.
The test is authorised for use by patients who are 14 years and above, who are suspected of having COVID-19. However, those who are under 14 must be tested at the hospital or the doctor's office. It is a must for health care providers to report the results of the test from individuals using the approved test-kit in order for public health authorities to continue tracking and monitor cases.
Dr Stephen Hahn, FDA Commissioner, said that the agency continues to demonstrate the speed, by which it responded to the pandemic. He said that although diagnostic tests for COVID-19 have been authorised for collection at home, this kit is one of the firsts that could be fully self-administered at home, with results provided without necessitating sending the results to the lab. He also said this testing option is important in addressing the pandemic as it helps in reducing the burden of the public about the possibility of transmitting the disease if they do not get tested.
One of the great things about Lucira's product is that it eliminates the use of an outside lab to determine the results. The home test kit is like an all-in-one package that could deliver results in a jiffy. Before Lucira, the FDA approved LabCorP's COVID-19 RT-PCR Test, which was the first one that had a collection option. However, the sample is still needed to be mailed to a lab to be tested. This time around, everything can be done at home.
Dr Jeff Shuren, director of the center for devices and radiological health of the FDA said that the test could help the public in taking immediate action to protect themselves as well as others.