FDA Allows 1st Rapid Virus Test That Gives Results At Home
Source: AP News
WASHINGTON (AP) U.S. regulators on Tuesday allowed emergency use of the first rapid coronavirus test that can be performed and developed entirely at home. The announcement by the Food and Drug Administration represents an important step in U.S. efforts to expand testing options for COVID-19 beyond health care facilities and testing sites.
However, the test will require a prescription, likely limiting its initial use. The FDA granted emergency authorization to the 30-minute test kit from Lucira Health, a California manufacturer. The companys test allows users to swab themselves to collect a nasal sample. The sample is then swirled in a vial that plugs into a portable device, that interprets the results and displays whether the person tested positive or negative for coronavirus.
To date, the agency has authorized nearly 300 tests for coronavirus. The vast majority require a nasal swab performed by a health professional and must be processed at laboratories using high-tech testing equipment. A handful allow people to collect their own sample at home a nasal swab or saliva thats then shipped to a lab, which usually means waiting days for results.
Health experts have for months called for options to allow people to test themselves at home, reducing turnaround times and the potential spread of the virus to health care workers. Lucira did not immediately respond to request for additional details. ~
Read more: https://apnews.com/article/coronavirus-pandemic-0430fe7460b4385bd952978f19b3d88d
intrepidity
(7,290 posts)mpcamb
(2,870 posts)"FDA release did not disclose the tests accuracy or the study results that regulators used to make the decision."
sprinkleeninow
(20,235 posts)BadgerKid
(4,550 posts)A friend of mine strongly suspected having a sinus infection but the doctor made him get a Covid test prior to granting an appointment. After a negative result three days later, he was given a prescription for the infection.
marble falls
(57,063 posts)... got her Covid-19 results yesterday. Negative.
PSPS
(13,588 posts)DeminPennswoods
(15,276 posts)This seems more advanced and likely more accurate.
marble falls
(57,063 posts)IsItJustMe
(7,012 posts)In a Community Testing Study, where the Lucira test was compared to a FDA authorized known high sensitivity SARS-CoV-2 test, Lucira achieved a 94% positive percent agreement (PPA) and a 98% negative percent agreement (NPA). Excluding samples with very low levels of virus that possibly no longer reflected active infection1, Lucira achieved 100% positive percent agreement.
1. La Scola B., Clinical Infectious Diseases, September 2020
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I wonder how $$$ this test will cost?