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FDA Should Get Out of the Way of At-Home COVID-19 Testing. Private-sector efforts to fill the testing vacuum run afoul of bureaucracy.
Reason ^ | March 23, 2020 | Ronald Bailey

Posted on 03/24/2020 5:58:49 AM PDT by karpov

Four different at-home diagnostic companies are planning to offer tests for coronavirus infection to health care workers and the public in the next week or so. One of the companies is the Austin-based Everlywell, which says it will make as many as 30,000 tests available to health care providers today. The company aims to return results to consumers within 48 hours after the labs receive the test samples, and it says it will offer telehealth consultations to folks who test positive. Positive results will be communicated to all mandated federal and state reporting agencies. The company says it will take no profits from the $135 test.

By working with multiple labs, the company plans to ramp up to a testing and diagnosis capacity for a quarter of a million people weekly. Compare this with the latest Centers for Disease Control and Prevention (CDC) report, which says just under 72,000 tests have been run in the U.S. so far.

Dr. George Rutherford, a physician at the University of California, San Francisco, who investigates the control of infectious diseases, thinks it's important for this to move forward. "Countries like South Korea have done 270,000 coronavirus tests trying to get this thing under control, and America has done far less than that," he told Fortune. "We need a lot of tests in many forms, and we need them now."

The Food and Drug Administration (FDA) has had a different response. "We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19," declared the FDA's associate commissioner for regulatory affairs, Judith A. McMeekin, in a March 20 press release.

(Excerpt) Read more at reason.com ...


TOPICS: Business/Economy; Culture/Society; Government
KEYWORDS: coronavirus; fda
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1 posted on 03/24/2020 5:58:49 AM PDT by karpov
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To: karpov

I’m not sue random testing will help. What do you do with the info? We don’t have the resources to track contacts alike they are doing in Korea. Right now everybody who knows how to intubate is on duty. When we begin to return people to their lives in stages testing will have a very valuable role.


2 posted on 03/24/2020 6:13:05 AM PDT by wastoute (Government cannot redistribute wealth. Government can only redistribute poverty.)
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To: karpov

It is imperative we focus our resources that are precious where they will actually do good.


3 posted on 03/24/2020 6:14:02 AM PDT by wastoute (Government cannot redistribute wealth. Government can only redistribute poverty.)
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To: wastoute

Random testing would help estimate the real number of people infected.

If only symptomatic folks get tested there is no way to know how many asymptotic people there are or how many peoplemay have been sick and got better without knowing it waa Wuhan.


4 posted on 03/24/2020 6:23:39 AM PDT by The Free Engineer
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To: karpov

It’s amazing that Ronald Bailey, author of this article in Reason, which was posted yesterday 3-23 at 1:05 pm, says the following:
“Compare this with the latest Centers for Disease Control and Prevention (CDC) report, which says just under 72,000 tests have been run in the U.S. so far.”
https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/testing-in-us.html
Then you can follow the link in his article to the CDC website, which as of 3-23 says this:

“Data during this period are incomplete because of the lag in time between when specimens are accessioned, testing is performed, and results are reported.”
And then you can get the truth, which is still biased low because some states are not reporting negative test results, which is that at least 303,014 Covid19 test have been run in the US, and there were more than 66,000 tests run in 24 hours YESTERDAY 3-23.
As they say at Faber College, “Knowledge is Good”
https://covidtracking.com/data/


5 posted on 03/24/2020 6:23:41 AM PDT by brookwood (Obama said you could keep your plan - Sanders says higher taxes will improve the weather)
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To: The Free Engineer

If I could give you a precise # of infected at this moment what would you do with the information? It will be wrong in an hour.


6 posted on 03/24/2020 6:28:43 AM PDT by wastoute (Government cannot redistribute wealth. Government can only redistribute poverty.)
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To: karpov

We have to remove the authority of the FDA to prevent ANYTHING.

It must be a government organized form of setting “Best Practices” standards in the medical field, which as good as they might be to be followed, are not legally required to be followed. That change should additionally only require medical practitioners and medical product providers must acknowledge what they are using, or doing has the “FDA approved” status or not. As long as that is transparent, the consumer is informed.


7 posted on 03/24/2020 6:50:42 AM PDT by Wuli
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To: wastoute

“It is imperative we focus our resources that are precious where they will actually do good.”

What has that statement got to do with individuals being able to obtain there own Cov-19 test????????


8 posted on 03/24/2020 6:52:04 AM PDT by Wuli
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To: Wuli

You would like to provide tests for people who have been told to stay home so they can use that information to stay home?


9 posted on 03/24/2020 6:53:37 AM PDT by wastoute (Government cannot redistribute wealth. Government can only redistribute poverty.)
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To: The Free Engineer

And people could individually self-quarantine and tell employers and workers of their status so that they too can get their own tests done. Once someone made that status known to their employer soon all the employees would know those remaining at work tested negative. No federal police, no state police, just people with the means to operate safely on their own.


10 posted on 03/24/2020 6:55:34 AM PDT by Wuli
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To: Wuli

Exactly! “Informed Consent”. Everyone who takes this drug who is conscious should be informed about “Quinism”. It is a side effect and it is unethical to fail to do so. Then, ethically you can give it to everyone who agrees. Think of it as the largest ad how experiment in history. And all the other risks one takes with this drug such as previously unknown G6PD Def.. It is the definition of Informed Consent.


11 posted on 03/24/2020 6:56:42 AM PDT by wastoute (Government cannot redistribute wealth. Government can only redistribute poverty.)
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To: Wuli

Once the “fires” in the hospitals have been put out, certainly so.


12 posted on 03/24/2020 6:57:29 AM PDT by wastoute (Government cannot redistribute wealth. Government can only redistribute poverty.)
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To: wastoute

“You would like to provide tests for people who have been told to stay home so they can use that information to stay home?”

What the ^&&%$$ are YOU talking about???


13 posted on 03/24/2020 6:59:46 AM PDT by Wuli
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To: Wuli

In the entire history of Medicine (until this week) a medical test is, in essence, a question. What do you propose to do with the information? If the answer is “nothing” you are being irresponsible to order it. So my question to you is what is the question you would like to ask?


14 posted on 03/24/2020 7:02:58 AM PDT by wastoute (Government cannot redistribute wealth. Government can only redistribute poverty.)
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To: karpov

The family Coronaviridae is organized in 2 sub-families, 5 genera, 23 sub-genera and about 40 species. The viruses cause respiratory infections, including the common cold, which are typically mild, though rarer forms such as SARS, MERS and COVID-19.

So how do the tests accurately tell that the virus is the Chinese virus, or the common cold? To make matters worse, such tests usually do not test the virus itself, but the bodies’ antibodies against it.


15 posted on 03/24/2020 7:03:55 AM PDT by yefragetuwrabrumuy (Liberalism is the belief everyone else should be in treatment for your disorder.)
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To: yefragetuwrabrumuy

Right. Being treated like mushrooms again.

Kept in the dark and being fed manure.


16 posted on 03/24/2020 7:05:59 AM PDT by JayAr36 (The worthless dispicable party must be destroyed)
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To: Wuli

The most important thing you could estimate are accurate death rates.


17 posted on 03/24/2020 8:19:49 AM PDT by The Free Engineer
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To: The Free Engineer

“Random testing would help estimate the real number of people infected.”

This is how the government determined the amount of homosexuals in the US by asking prisoners as they were incarcerated. And that was far more financially sound as it didn’t constitute a test kit for over $1000 each.

rwood


18 posted on 03/24/2020 8:22:21 AM PDT by Redwood71
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To: The Free Engineer
To make an accurate estimate you must have data. You must have adequate data points

Fragmented and disassociated data can't yield an accurate estimate.


19 posted on 03/24/2020 8:23:02 AM PDT by bert ( (KE. NP. N.C. +12) Progressives are existential American enemies)
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To: karpov

We need this, because we are sending people with probably CV, but with mild or partial symptoms, home without testing. Telling them to just isolate for 2 weeks.

But if they don’t have it, we are scaring them and isolating them for no reason. If they DO have it, they should probably test again after 2 weeks to see if they have shed it.

At-home tests would fill this void. And currently, the costs of these are high enough that people won’t just be testing themselves once a week just to be sure.


20 posted on 03/24/2020 9:33:14 AM PDT by CharlesWayneCT
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