Monday, July 27, 2020

FDA OKs Tests for C19 Asymptomatics

The FDA issued the following statement Friday.

Today, the U.S. Food and Drug Administration reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use: testing for people who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection, and to allow pooled sample testing. The FDA reissued the LabCorp COVID-19 RT-PCR Test EUA to expand use of the test to anyone, after the company provided scientific data showing the test’s ability to detect SARS-CoV-2 in a general, asymptomatic population. Additionally, the reissuance includes authorization for LabCorp to test pooled samples containing up to five individual swab specimens collected under observation. Sample pooling allows for fewer tests to be run overall, conserving resources and potentially allowing more samples to be evaluated quicker.

“FDA’s authorization of the first diagnostic test to be used for anyone, regardless of whether they are showing symptoms of COVID-19 or have other exposure risk factors, is a step toward the type of broad screening that may help enable the reopening of schools and workplaces,” said FDA Commissioner Stephen M. Hahn, M.D. “By authorizing another test for use with pooled samples, we also further help increase the possibility that patients may be able to receive results sooner, while also conserving vital testing supplies, which are under increased demand during the pandemic. Continuing to facilitate increased access to accurate and reliable tests for all Americans is critically important and the FDA continues to work around the clock with test developers to support this goal.”

The FDA recognizes that organizations may want to conduct screening of asymptomatic people as part of a broader strategy to help ensure the safety of their employees, patients, students and others. Last month, the FDA posted updated templates with recommendations for test developers to demonstrate validation for a test to be authorized for screening of asymptomatic people, as well as for sample pooling. Last week, the FDA authorized the first COVID-19 test that could be used with pooled samples.

The LabCorp test remains prescription-only and is authorized for human specimen collection either at home using the Pixel by LabCorp or other home sample collection kits authorized for use with LabCorp’s test, or by a health care provider. However, only health care provider-collected samples may be pooled at this time. Additionally, the data reviewed by the FDA demonstrated that the test is as accurate in the broader asymptomatic population as it is among people suspected to have COVID-19.

The LabCorp test was originally issued an EUA on March 16 for use only in people suspected of being ill with COVID-19 by their health care provider and for testing of individual specimens without sample pooling. Until now, molecular diagnostic tests have generally been authorized for people suspected of having COVID-19 by their health care provider, which has allowed asymptomatic people to be tested, when warranted, at the discretion of the health care provider. Today’s authorization eliminates the need for a provider to consider risk factors such as exposure or community spread when prescribing this test. The FDA continues to work with test developers to expand access to COVID-19 testing.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


Anonymous said...

It seems that some want everyone to perceive they are sick. That way, the crowd is easier to manipulate. It’s all about manipulating the majority. I have to laugh at how gullible some of you are.

Anonymous said...

12:21 -- Nobody wants to be sick with this virus. My son and granddaughter stayed isolated -- his job closed -- and only went to Walmart for essential groceries. He wore a mask and washed his hands. Then 10 days ago he came down with fever, a severe headache, body aches, explosive diarrhea, that lasted for five days, loss of smell and taste. He is not over it yet, although the symptoms are fading. The granddaughter fared better, but was still sick. Nobody that has it is "perceived sick." You get it you are SICK. I'll bet you are one of the idiots not wearing a mask.

Anonymous said...

@12:21 - you must own stock in tin foil? That’s the only explanation I was able to come up with to explain your reasoning.

Sol Juette said...

When they ask you to sip on the grape kool-aid, what will you do?

Anonymous said...

As it relates to re-opening, a test is only helpful if it can deliver very rapid results. Having to wait a week or more for results isn't going to help at all.

Anonymous said...

12:21 is a troll. The purpose of FDA issuing this is to save on reagents. Nationwide, about 90% of the tests come back negative. By pooling the samples, they can cut down on the use of reagents and process more tests at the same time.

For example, if you have 100 samples to test, and you pool them by groups of 4, then you only test 25 pooled samples. If 10% of the 100 original samples are positive, you would expect 3 of the pooled samples to test positive. Of the 3 pooled samples that test positive, now you test every original sample individually (3 pooled samples = 12 original tests).

That means you have 25 pooled sample tests plus 12 original sampled tests that you have to run a second time, for a total of 37 tests run. That saves you from running an extra 63 tests, and thus saves on the use of reagents.

7:15 is incorrect. You can get Covid-19 and have zero symptoms.

I was tested for Covid-19, and came back positive. I never had a fever, or cough, or tiredness. I continued my pre-dawn 7 mile run every morning. I isolated from others the rest of the day. Fortunately, I can telework. I tested negative this past week.

I will continue to wear a mask, physically distance myself when I go out, and wash my hands. It is just common sense, and is showing love for my neighbor.

Leviticus 19:18
Mark 12:30-31

Anonymous said...

More tests more positives and more panic. Sounds good to me. Already tested negative twice myself (no symptoms work mandated), but now we can keep testing until we get where we want to be. Good for treating facility and Provider finances. Yes they (Government) do pay for the ill, regardless of status.

Anonymous said...

Medically factual? Yes. Properly sourced? Yes. Approved comment? No.

Anonymous said...

@8:14, where can one buy tin foil? I have never seen it for sale in stores. Plenty of aluminum but no tin.

Maybe you just knee jerk react in mockery to subjects you are unable to comprehend? Or perhaps you are a shill.

Anonymous said...

@8:40. Good comment. Only alteration to your explanation is that LabCorp has figured out a 4X4 matricies so that (depending on the prevalence of the population), they won't necessarily have to retest positive samples to know which one was positive.

Anonymous said...

@9:49, you got me - I am actually Bill Gates. You were right all along about my plans. Once I get the mask wearers to take their micro chipped vaccine, I can track all the democratic citizens of the world and turn them into gay communists and confiscate all their guns and bibles.

Anonymous said...

@7:15 reading skills are key to success in life. The guy at at 12:21 is referring to asymptomatic “victims”

@8:40, congrats, you tested positive for antibodies you picked up from a coronavirus infection you had many years ago, as are most “asymptomatic” people. Asymptomatic is 2020 newspeak for negative

Anonymous said...

I hate to burst your anecdotal bubble 7:15, but I have a friend who was forced to get tested at his job and tested positive. He is 60 years old and said he has had allergies worse than Covid.
I’m not saying ALL cases are mild, but you are saying ALL cases are more than “perceived sick”.
My friend said “I wouldn’t know I had if they had not told me.”

I actually lost a loved one to the illness so I’m not saying to take it lightly, I just don’t subscribe to a one size fits all fear based diagnosis when even doctors are baffled by the varying degrees of sickness it causes.

Anonymous said...

When will Tate extend his mask mandate Statewide to show he is serious?

Anonymous said...

Kim Wade was on fire today. He was dropping truth bombs and red pills left and right. I was especially inspired by his mention of the Initiates of the Flame, aka the Brotherhood of the Serpent, aka the Illuminati.
And when he started talking about white genocide, I knew it wasn't going to be a normal episode. It is unfortunate that such topics are censored here.

Anonymous said...

I've been taking this latest Chinese virus very seriously.

But until I feel I need for a test, it ain't going to happen.

Yeah, I wear a mask in public . . .
but I'll agree to an asymptomatic only on my terms.

(Not Tate's or Dr. Dobb's) .

To be honest, I would prefer an opinion from Doctor Doolittle.

After all . . . he can talk to the animals.

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Trollfest '09

Trollfest '07 was such a success that Jackson Jambalaya will once again host Trollfest '09. Catch this great event which will leave NE Jackson & Fondren in flames. Othor Cain and his band, The Black Power Structure headline the night while Sonjay Poontang returns for an encore performance. Former Frank Melton bodyguard Marcus Wright makes his premier appearance at Trollfest singing "I'm a Sweet Transvestite" from "The Rocky Horror Picture Show." Kamikaze will sing his new hit, “How I sold out to da Man.” Robbie Bell again performs: “Mamas, don't let your babies grow up to be Bells” and “Any friend of Ed Peters is a friend of mine”. After the show, Ms. Bell will autograph copies of her mug shot photos. In a salute to “Dancing with the Stars”, Ms. Bell and Hinds County District Attorney Robert Smith will dance the Wango Tango.

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This is definitely a Beaver production.

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Trollfest '07

Jackson Jambalaya is the home of Trollfest '07. Catch this great event which promises to leave NE Jackson & Fondren in flames. Sonjay Poontang and his band headline the night with a special steel cage, no time limit "loser must leave town" bout between Alan Lange and "Big Cat"Donna Ladd following afterwards. Kamikaze will perform his new song F*** Bush, he's still a _____. Did I mention there was no referee? Dr. Heddy Matthias and Lori Gregory will face off in the undercard dueling with dangling participles and other um, devices. Robbie Bell will perform Her two latest songs: My Best Friends are in the Media and Mama's, Don't Let Your Babies Grow up to be George Bell. Sid Salter of The Clarion-Ledger will host "Pin the Tail on the Trial Lawyer", sponsored by State Farm.

There will be a hugging booth where in exchange for your young son, Frank Melton will give you a loooong hug. Trollfest will have a dunking booth where Muhammed the terrorist will curse you to Allah as you try to hit a target that will drop him into a vat of pig grease. However, in the true spirit of Separate But Equal, Don Imus and someone from NE Jackson will also sit in the dunking booth for an equal amount of time. Tom Head will give a reading for two hours on why he can't figure out who the hell he is. Cliff Cargill will give lessons with his .80 caliber desert eagle, using Frank Melton photos as targets. Tackleberry will be on hand for an autograph session. KIM Waaaaaade will be passing out free titles and deeds to crackhouses formerly owned by The Wood Street Players.

If you get tired come relax at the Fox News Tent. To gain admittance to the VIP section, bring either your Republican Party ID card or a Rebel Flag. Bringing both will entitle you to free drinks.Get your tickets now. Since this is an event for trolls, no ID is required, just bring the hate. Bring the family, Trollfest '07 is for EVERYONE!!!

This is definitely a Beaver production.

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