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Coronavirus (COVID-19) Update: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing
fda.gov/ ^ | 7/18/2020 | fda.gov/

Posted on 07/18/2020 8:39:44 AM PDT by bitt

Today, the U.S. Food and Drug Administration reissued an emergency use authorization (EUA) to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual swab specimens collected under observation. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples.

Sample pooling is an important public health tool because it allows for more people to be tested quickly using fewer testing resources. Sample pooling does this by allowing multiple people – in this case four individuals – to be tested at once. The samples collected from these four individuals are then tested in a pool or “batch” using one test, rather than running each individual sample on its own test. If the pool is positive, it means that one or more of the individuals tested in that pool may be infected, so each of the samples in that pool are tested again individually. Because the samples are pooled, it is expected that fewer tests are run overall, meaning fewer testing supplies are used and more tests can be run at the same time allowing patients to receive their results more quickly in most cases. This testing strategy is most efficient in areas with low prevalence, meaning most results are expected to be negative.

“This EUA for sample pooling is an important step forward in getting more COVID-19 tests to more Americans more quickly while preserving testing supplies,” said FDA Commissioner Stephen M. Hahn, M.D. “Sample pooling becomes especially important as infection rates decline and we begin testing larger portions of the population.”

(Excerpt) Read more at fda.gov ...


TOPICS:
KEYWORDS: diagnostictesting; fda; samplepooling

1 posted on 07/18/2020 8:39:44 AM PDT by bitt
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To: Whenifhow; null and void; aragorn; EnigmaticAnomaly; kalee; Kale; 2ndDivisionVet; azishot; ...

p


2 posted on 07/18/2020 8:39:57 AM PDT by bitt (Let justice be done though the heavens fall - Fiat justitia ruat caelum)
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To: bitt

Another way to keep the fraud going.


3 posted on 07/18/2020 8:43:09 AM PDT by gov_bean_ counter (AOC the bartender would have had to work on the second floor at Miss KittyÂ’s saloon...)
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To: gov_bean_ counter; bitt

A pool of four positives, for every actual positive you mix in.

If only the test were sensitive enough to be cut by ten or a hundredfold, we could really get some panic and emergency powers.


4 posted on 07/18/2020 8:54:09 AM PDT by BeauBo
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To: bitt

Another way to report fake CCP virus cases!

Yay!


5 posted on 07/18/2020 9:08:04 AM PDT by E. Pluribus Unum (The "pandemic" is a Democrat election-year hoax. China wants you to vote Democrat.)
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To: BeauBo

This makes RTW protocols cheaper and promotes reopening, it isn’t a tool of the panicmongers. So this makes a lot of sense actually. It’s a much cheaper way of testing when you are doing routine testing for populations in a hospital or school or nursing home or whatever.

You don’t record 4 positives, you go back and re-test the 4 people or whatever in the pool individually. Bc most pools won’t have even 1 positive, you save a lot of money on test processing.


6 posted on 07/18/2020 9:10:31 AM PDT by socalgop
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To: socalgop

Going back and testing out the 4 individual samples is what they should do, it doesn’t mean they’ll do it, and not count all 4 samples as positive. I just don’t trust them. Falsifying test results is just okie dokie if it’s for the cause, don’tcha know.


7 posted on 07/18/2020 9:29:00 AM PDT by virgil (The evil that men do lives after them)
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To: socalgop

“You don’t record 4 positives, you go back and re-test the 4 people”

“Don’t”, should be written as shouldn’t”.

Systematic over counting/double counting has been a widespread problem. This is another opportunity. Just report that the four samples were tested positive, then another day report the one positive on the re-test. Voila! Five new cases in the total.

Lots of double counting has been occurring, like when cases are admitted to facilities near the border in California (and reported), and then evacuated to different facilities in the middle of the State (who of course, separately report their totals, in a different County).

There has been counting of contacts as “cases”, without testing them. There has been widespread counting of antibody positives as cases, even though they are not infectious and pose no load on the health care system. There have been many incidents of simply fraudulent cases reported, to bilk medical payments from the Government.

And clearly, some harbor a political motive to jack up the number of cases, and actively seek out such methods - which is likely why consolidation of reporting, recently had to be taken out of the hands of the clique of bureaucrats at the CDC, who were systematically over-reporting.


8 posted on 07/18/2020 9:47:01 AM PDT by BeauBo
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