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| DIY Covid test kit approved for 'emergency use' by FDA, but requires prescription. (Page 1/1) |
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rinselberg
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NOV 18, 05:55 AM
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YOU ARE ENTERING A REALM OF DUPLICATED TEXT
WASHINGTON — U.S. regulators on Tuesday allowed emergency use of the first rapid coronavirus test that can be performed entirely at home and delivers results in 30 minutes.
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 single-use test kit from Lucira Health, a California manufacturer.
The company's test allows users to swab themselves to collect a nasal sample. The sample is then swirled in a vial of laboratory solution that plugs into a portable device. Results are displayed as lights labeled positive or negative.
To date, the FDA 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 equipment. A handful of tests allow people to collect their own sample at home — a nasal swab or saliva — that’s then shipped to a lab, which usually means waiting days for results.
. . .
More online from KARE television, Minneapolis:
https://www.kare11.com/arti...a4-887e-41f16ec412a1
Lucira Health Covid-19 All-In-One Test Kit
https://www.lucirahealth.com[This message has been edited by rinselberg (edited 11-18-2020).]
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maryjane
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NOV 18, 08:11 AM
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Are they molecular or antigen tests?
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sourmash
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NOV 18, 08:49 AM
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I'm still not falling for this farce.
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rinselberg
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NOV 18, 12:52 PM
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| quote | Originally posted by maryjane:
Are they molecular or antigen tests? |
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I think it's a "molecular." That's how I read the Lucira web page:
| quote | Lucira’s COVID-19 All-In-One Test Kit is a molecular in vitro diagnostic test that has an analytical sensitivity, or ability to detect the SARS-CoV-2 virus, that is comparable to some of the best molecular tests performed in clinical settings and high complexity labs.
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. |
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[This message has been edited by rinselberg (edited 11-18-2020).]
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