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Coronavirus Antibodies: FDA Approves First COVID-19 Serology Test, Could Lead To Plasma Treatment
International Business Times ^ | 04/02/2020 | Marcy Kreiter

Posted on 04/02/2020 5:47:25 PM PDT by SeekAndFind

The Food and Drug Administration on Thursday authorized its first emergency use coronavirus serology test, opening the way for a possible treatment for COVID-19, which has infected some 1 million worldwide and killed more than 51,000. The test will determine if a person has been infected.

The test was developed by Cellex Inc. and involves a blood draw done at a certified lab. It can provide results in 15 minutes.

“Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19,” FDA chief scientist Denise M. Hinton said in a letter to Cellex CEO James X. Li.

“The known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product.”

The test will determine whether an individual has developed antibodies to the virus, which would be detectable within days of initial infection, and will be used on people who are suspected of having the virus. The Centers for Disease Control and Prevention is developing its own test, which could be used for people with mild or no symptoms.

Becton, Dickinson and Co. and BioMedomics earlier this week announced a similar antibody test but has yet to receive the FDA’s emergency approval.

Antibody testing differs from the testing being done to determine whether individuals are suffering from coronavirus, which involve nasal swabs.

Presence of antibodies could open the way for the use of convalescent plasma although the process is expensive, and it was unclear whether it was a viable treatment.

Plasma is the liquid that’s left once blood cells are removed. Plasma from people who have recovered from the virus could be given to sick patients to help them fight off the disease. Doctors in New York and Houston began plasma treatments during the weekend, USA Today reported.

Preliminary research from China published by JAMA indicates convalescent plasma helped five critically ill COVID-19 patients recover.

“These preliminary findings raise the possibility that convalescent plasma transfusion may be helpful in the treatment of critically ill patients with COVID-19 and ARDS, but this approach requires evaluation in randomized clinical trials,” the Chinese researchers said.

Scientists have found eight strains of the coronavirus circulating.

By midafternoon Thursday, the U.S. had recorded 234,462 confirmed coronavirus infections with 5,607 deaths.


TOPICS: Culture/Society; Front Page News; Government; News/Current Events
KEYWORDS: antibody; chinavirus; chinavirusinfo; chinavirusnews; coronavirus; plasma; serology
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1 posted on 04/02/2020 5:47:25 PM PDT by SeekAndFind
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To: SeekAndFind
“The known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product.”

What are the known and potential risks of drawing a tube of blood from somebody? That they might get a bruise at the phlebotomy site? It's not like we'll be eating the test kit.

2 posted on 04/02/2020 5:53:46 PM PDT by Shethink13 (there are 0 electoral votes in the state of denial)
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To: SeekAndFind

Transfusion etc etc....$20,000.


3 posted on 04/02/2020 5:56:56 PM PDT by Sacajaweau
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To: SeekAndFind

More than enough supposition to go around.

And who assumes the risk for the use of convalescent plasma treatment?

Future TV advert: Flat feet, weight problems, lumbago...
Did you have Wu-flu...

CALL NOW! Attorneys are waiting $$$


4 posted on 04/02/2020 6:00:46 PM PDT by DUMBGRUNT
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To: Shethink13

who is going to donate this plasma anyway?....there has been so much hate thrown at college students and they would be the best to get the plasma from, but why should they?.....


5 posted on 04/02/2020 6:01:01 PM PDT by cherry
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To: Sacajaweau
Transfusion etc etc....$20,000.

I'm getting tested. If I have immunity I would give my plasma gladly but my main reason would be just to know that I am protected.

Maybe if enough people demanded it - it should be offered FREE OF CHARGE (the testing that is) to anyone who wishes to know. Surely they can scrape a couple of bucks together out of that $2.2T to give us peace of mind and let us get on with out lives, right?

6 posted on 04/02/2020 6:02:55 PM PDT by Shethink13 (there are 0 electoral votes in the state of denial)
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To: Shethink13
As long as the donors get tested for AIDS, Hep B, Hep C, hemophilia, and other contagious blood-borne diseases. But, the powers that be are sucking up to SJWs, the Gay Mafia, and Wokeness, with this recent announcement: US Eases Blood Donation Limits for Gay Men Due to Shortage on April 2, 2020.

The "potential risk" could be quite high.

7 posted on 04/02/2020 6:04:26 PM PDT by ProtectOurFreedom
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To: DUMBGRUNT
More than enough supposition to go around.

And who assumes the risk for the use of convalescent plasma treatment?

Who assumes the risk for the off label use of Chloroquine?

This is nothing new.

Convalescent plasma: new evidence for an old therapeutic tool?

I want to be tested to know whether I have immunity. You don't care to know?

8 posted on 04/02/2020 6:09:35 PM PDT by Shethink13 (there are 0 electoral votes in the state of denial)
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To: ProtectOurFreedom
As long as the donors get tested for AIDS, Hep B, Hep C, hemophilia, and other contagious blood-borne diseases. But, the powers that be are sucking up to SJWs, the Gay Mafia, and Wokeness, with this recent announcement: US Eases Blood Donation Limits for Gay Men Due to Shortage on April 2, 2020.

The "potential risk" could be quite high.

Um....they're talking about the serological testing kit, NOT the convalescent plasma therapy.

9 posted on 04/02/2020 6:12:03 PM PDT by Shethink13 (there are 0 electoral votes in the state of denial)
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To: Shethink13

Oh. Oops. Thanks for clarifying. I’m skimming too quickly. ;>(


10 posted on 04/02/2020 6:19:17 PM PDT by ProtectOurFreedom
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To: Shethink13
This is nothing new.

Convalescent plasma,
True.

And what if the test allows live viruses to be transmitted? Only takes a few.

Chloroquine?
IIRC is one of the two antimalarial drugs I took for two and a half years in RVN.
https://www.military.com/daily-news/2020/03/23/drug-touted-covid-19-treatment-has-troubling-side-effects-experts-say.html

And yes, I'm perfectly normal, and have the papers to prove it! (an old joke)

Yes, I want to be tested.
Sooner or later I'd like to see my grandchildren again.
A granddaughter has some medical issues and her physician recommends avoiding everyone.

11 posted on 04/02/2020 6:31:39 PM PDT by DUMBGRUNT
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To: Shethink13

Thank you, the abstract was interesting, will probably pass on the 796K PDF. Still might give a quick look.

This reinforces what I have previously read; there are no vaccines or CBP therapies for earlier SARS, flu, COVID... From years past.

Experiments and small studies, nothing more;
“immunotherapy using monoclonal antibodies could be more effective;”
Not exactly a dead end but the new stuff looked better.

From your link:
In the following decades, possible therapeutic efficacy was claimed for the management of measles, Argentine haemorrhagic fever, influenza, chickenpox, infections by cytomegalovirus, parvovirus B19 and, more recently, Middle East respiratory syndrome coronavirus (MERS-CoV), H1N1 and H5N1 avian flu, and severe acute respiratory infections (SARI) viruses19–29. Furthermore, animal models of influenza pneumonia have shown the benefit of CS (protection against H1 and H3 challenge), equine hyperimmune F(ab’)2 globulin (protection against H5N1 challenge), and monoclonal antibodies (against H1, H3, and H5N1 challenge)30–32.


12 posted on 04/02/2020 7:29:47 PM PDT by DUMBGRUNT
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To: SeekAndFind

Also find out if you are immune


13 posted on 04/02/2020 8:09:52 PM PDT by dila813
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To: DUMBGRUNT
And what if the test allows live viruses to be transmitted? Only takes a few.

I'm sure you've had lab tests performed, right? CBC, Chemistry tests, maybe INR for coumadin therapy. It's just another tube of blood they will collect. It's coming from you and nothing is being put into you. No worries about that.

I'm glad you'd like to get tested and I hope you see your grandchildren too. All the best.

14 posted on 04/02/2020 10:15:28 PM PDT by Shethink13 (there are 0 electoral votes in the state of denial)
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To: ProtectOurFreedom
Oh. Oops. Thanks for clarifying. I’m skimming too quickly. ;>(

Oh gosh...I NEVER do that...

Regards

15 posted on 04/02/2020 10:17:07 PM PDT by Shethink13 (there are 0 electoral votes in the state of denial)
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To: Shethink13
I've been saying this for awhile. We need to see who has immunity. If there is immunity we can also do studies to see how long the immunity is good for. I am also still convinced that there is a LOT of immunity already out there.
16 posted on 04/02/2020 11:40:44 PM PDT by Ymani Cricket (Pressure makes diamonds - General Patton)
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To: Shethink13
Surely they can scrape a couple of bucks together out of that $2.2T to give us peace of mind and let us get on with out lives, right?

Sorry Kennedy Center and NPR, we have a national crisis on our hands.

And don't call me Shirley.

17 posted on 04/03/2020 4:49:09 AM PDT by ROCKLOBSTER (We need to reach across the aisle, extend a hand...And slap the crap out of them)
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To: Shethink13

I’m not attempting to troll, just my point of view.

Being a septuagenarian (jg), I do not recall too many ‘Chemistry tests’, maybe when I get much older?

I did have a biochemistry test about 50+ years ago and with pure luck I passed!

“It’s coming from you and nothing is being put into you. No worries about that.”

Totally true. An EVIL car ran over me on my bicycle 20 days hospital, RVN shot in the head... Yes, many punctures of my precious hide, still doing well.

The problem with Convalescent Blood Plasma (CBP) is the possible transmission of the active virus. The doner plasma is injected into the subject.

With traditional vaccines, this is well understood, CBP not so much.

From the abstract Pg 152:

” Notably, the use of pathogen inactivation could guarantee additional safety thus supporting less strict selection criteria”

Pathogen inactivation, still working on that...


18 posted on 04/03/2020 9:11:00 AM PDT by DUMBGRUNT
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To: DUMBGRUNT
The problem with Convalescent Blood Plasma (CBP) is the possible transmission of the active virus. The doner plasma is injected into the subject.

Well then you do not understand what convalescent plasma is. Once you've recovered and develop immunity you are clear of the virus. It no longer exists and cannot remain in your system because the antibodies will attack and kill it.

You also don't seem to understand the theory of vaccination, although you are not alone believe me. Perhaps, if I give you a brief overview of how your body develops immunity it may help you and others to understand why a vaccine is far inferior to natural immunity.

When a virus enters your body (let's refer to it as the antigen), it will immediately seek out certain tissue cells to enter. There they begin to replicate and move on to the next cell etc. Your immunity is triggered when enough cells have been invaded for you to begin to have symptoms (threshold). Once your immunity kicks in it battles the invading virus until it is overcome and eliminated. Those who are immunocompromised may not be able to overcome the antigen and their symptoms become more serious. The antibodies formed are specific to that LIVE, REPLICATING VIRUS (antigen) and they are lifelong. Meaning if ever that pathogen (antigen) enters your body again it is immediately eliminated.

A vaccine, on the other hand, is an artificial stimulation of your immune system by using either a killed, attenuated or maybe even just a specific protein from the virus as the antigen. Because these are inert substances that are incapable of entering and replicating in your cells, your body does not perceive it as a threat. You may produce antibodies to those substances, but those antibodies are not going to be able to handle the live organism as well as naturally acquired antibodies.

Do not confuse a vaccine with plasma therapy as they are exact opposites. A vaccine is the ANTIGEN to attempt to stimulate nonexistent antibody. The plasma therapy is the ANTIBODY already formed and proven to kill the virus. Does that make sense?

You could sort of look at it like the difference between feeding your baby breast milk or formula. That which is produced naturally by the body is far superior to an artificially produced substitute.

You are fooling yourself if you think these vaccines are less risky than convalescent therapy. The vaccine does not only contain the antigen but various adjuvants, particularly in the multivalent flu (containing more than one strain of the flu) or multiple pathogens such as MMR, DPT etc.

The point is the tests we are speaking of are NOT preparing you to receive plasma therapy. They are to detect if you have been previously exposed and developed those antibodies naturally and are thus protected from the disease. In addition, if you're physically capable you could become a donor of this plasma.

19 posted on 04/03/2020 11:04:24 AM PDT by Shethink13 (there are 0 electoral votes in the state of denial)
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To: Shethink13

The plasma therapy is the ANTIBODY already formed and proven to kill the virus. Does that make sense?

Also, how many other virus antibodies via injections is our serum carry/covering from the flu shots, pneumonia shots, shingles, polio vaccines and the various virus we bumped into in our life time and possibly our ancestors’ lifetime?

Could our virus load be harmful if we donated blood to make serum to protect others as an injection?

Thanks for sharing your knowledge with us.

Please ping me when your post on this subject.

Thanks,
Dave


20 posted on 04/04/2020 7:10:53 AM PDT by Grampa Dave (NYers fleeing NY are presumed to be infected. They should be tested/quarantined in any other state!)
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