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DIY Covid test kit approved for 'emergency use' by FDA, but requires prescription. by rinselberg
Started on: 11-18-2020 05:55 AM
Replies: 3 (55 views)
Last post by: rinselberg on 11-18-2020 12:52 PM
rinselberg
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Report this Post11-18-2020 05:55 AM Click Here to See the Profile for rinselbergClick Here to visit rinselberg's HomePageClick Here to Email rinselbergSend a Private Message to rinselbergEdit/Delete MessageReply w/QuoteDirect Link to This Post
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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Report this Post11-18-2020 08:11 AM Click Here to See the Profile for maryjaneSend a Private Message to maryjaneEdit/Delete MessageReply w/QuoteDirect Link to This Post
Are they molecular or antigen tests?
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sourmash
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Report this Post11-18-2020 08:49 AM Click Here to See the Profile for sourmashClick Here to Email sourmashSend a Private Message to sourmashEdit/Delete MessageReply w/QuoteDirect Link to This Post
I'm still not falling for this farce.
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rinselberg
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Report this Post11-18-2020 12:52 PM Click Here to See the Profile for rinselbergClick Here to visit rinselberg's HomePageClick Here to Email rinselbergSend a Private Message to rinselbergEdit/Delete MessageReply w/QuoteDirect Link to This Post
 
quote
Originally posted by maryjane:
Are they molecular or antigen tests?

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.

[This message has been edited by rinselberg (edited 11-18-2020).]

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