Shresta Hebbar Amsadi
23rd November 2020
The US FDA authorizes first COVID-19 self-testing kits(Source: The Indian express)
On 17 November, the US Food and Drug Administration greenlighted the first coronavirus self-testing kit for home use that provides results within 30 minutes.
The nose-swab test is manufactured by Lucira Health, a company founded in 2013 and situated in Emeryville, California. The new test is authorised for at home-use for those who 14-years-old and older with suspected COVID-19 infection. And for children under 13, the test needs to be performed by a healthcare provider.
The FDA issued an emergency use authorisation to Lucira Health’s rapid all-in-one test that is intended to detect the virus to help counter the rising number of cases. While there exist some tests which allow people to send samples from home, this is the first which can be wholly self-administered and provide results in just 30 minutes. The Lucira test is only used for prescription use as of right now, and all the results are being reported to the government.
The Lucira test works by swirling the self-collected sample swab in a sample vial that is then placed in the test unit. A red light will indicate a positive result, and green light will indicate a negative one. 100 per cent were able to successfully execute the test within two minutes during clinical trials, Lucira reported.
The test kit is expected to cost around $50, according to MedCity News. However, it will not be made available nationwide until 2021, as stated by the company in a press release. The first batch of kits will be allotted to patients of Sutter Health, North California and Cleveland Clinic Florida.
“Being able to quickly determine if a person is infected or not has been a global problem,” said Dr John Chou, a physician and Sutter Health affiliate, in a statement, as reported by MedCity News. “We believe this highly mobile test can make a big difference by providing lab-quality results expeditiously and conveniently. Early, accurate detection is vital to delivering appropriate care and controlling the pandemic.”
As it still is the early stages of the deadly virus, complete self-testing isn’t advised around the world as there is a risk of human element playing a part which in turn has a possibility of giving false results. Another positive arising from the invention of this self-testing kit is that the workload of the testing labs might get significantly reduced.
(Sources: NDTV, Lucira Health, FDA, MedCity News)
Edited by: Suditi Jha