Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination: FDA Safety Communication

FDA Division of Industry and Consumer Education ^ | May 19, 2021 | Un-named FDA (DICE)

[Grandpa Drudge]

The U.S. Food and Drug Administration (FDA) is reminding the public and health care providers that results from currently authorized SARS-CoV-2 antibody tests should not be used to evaluate a person’s level of immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination.

[Grandpa Drudge]

In my opinion, this is incredible (and potentially criminal) misleading and misdirecting advice from our all powerful FDA

My first and most obvious conclusion is that the FDA is deliberately preventing all of us from finding out and proving that we don't need the vaccine because we already have strong immunity to Covid-19 (better than that provided by the vaccine) as a result of recovery from a previous infection.

If you have been paying attention, I don't have to tell you why, you already have a pretty good idea.

[Bobalu]

[House Atreides]

Well… so much for “following the science”. What a joke!

[rightwingcrazy]

“If you have a positive test result on a SARS-CoV-2 antibody test, it means that it is possible you were previously infected with the SARS-CoV-2 virus.”

“It is possible”, not “it is likely” or “it is certain”. That must mean either that the test may report the presence of antibodies that aren’t actually in your blood (false positive, contamination), or that the antibodies that they test for are not specific to this virus, or that the FDA is blowing smoke, or that it’s playing games with words. I wonder which is the case.

[Texas Fossil]

I give blood regularly, the regional hospital that runs the blood lab has in the past run antibody tests on me at least 2 times. The test is an “unapproved” test and each time I checked negative for Covid antibodies.

My wife and I think we may have had it early in the original outbreak. If we did, it was a mild case. We have since been exposed when my father was diagnosed with it, we have not had any sign of infection.

The last time I gave blood, I asked the lady that asked me all the questions about my history, if she had thought about the future of giving blood after Covid, and had she thought that possibly next year they might be asking if I ever had the mRNA vaccination? She did not answer directly, but I think she had considered it.

[blueplum]

those with sufficient levels of acquired immunity, whatever that is should be considered the same status as fully vaccinated; the FDA needs to reevaluate their statement

[Texas Fossil]

Yep, the FDA statement was repetitive and as clear as mud.

[Texas Fossil]

All of the above.

[Bobalu]

A shameless obfuscation :-/

[Texas Fossil]

Yes. It does nothing to instill faith in what they say.

Like legal weasel talk.

[Bobalu]

Take the PCR test, it can find anything....even if it’s not there...

[Captain Rhino]

LOL! Love your byline. Fits perfectly with the reader’s look of disbelief in the painting. Thanks for posting.

[FreedomPoster]

The fairly recent statement from public health authorities on vaccine approval was similarly unclear. This has been consistent from the beginning, lots of unclear and often contradictory statements.

[Bobalu]

The professions have their own unique vernacular...the intent is not really to confuse the public, it’s because the terms have a very specific and precise meaning...an attempt to avoid things like the meaning of “is”

[Grandpa Drudge]

Well, here's one from LabCorp with 100% Sensitivity and 99.8% Speciificity (meaning 100% sure a positive indicates IgG immunity antibodies to SARS-CoV-2 virus infection (nucleocapsid) and chance of false positive resilts = 0.2%)

SARS-CoV-2 Antibodies, Nucleocapsid TEST: 164068 Test number copied CPT: 86769

https://www.labcorp.com/tests/164068/sars-cov-2-antibodies-nucleocapsid

Test Details

Use

Qualitative detection of high affinity antibodies to SARS-CoV-2 nucleocapsid (N) protein, the virus that causes COVID-19, to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Note: This assay will not detect antibodies induced by currently available SARS-CoV-2 vaccines. This assay enriches detection of higher affinity antibodies which are more likely to be specific for SARS-CoV-2 N protein. While this assay in principle can detect high affinity antibodies of all isotypes (i.e., IgG, IgA, IgM), it preferentially detects IgG antibodies since these are more likely to evolve to become high affinity. Serologic results should not be used as the sole basis to diagnosis or exclude recent SARS-CoV-2 infection. This test is recommended for individuals at greater than or equal to 14 days post-symptom onset or following exposure to individuals with confirmed COVID-19.The incubation period for COVID-19 ranges from 5 to 7 days.

Limitations

This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA). This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. False positive results infrequently occur due to prior infection with other human Coronaviruses.

Note: This assay will not detect antibodies induced by currently available SARS-CoV-2 vaccines.

(Note the FDA position in italics, above.)

[Texas Fossil]

Yep. Legal weasel talk.

[Texas Fossil]

Yes. In other words, “they have lied to us daily since this began”. None of the “data” is accurate and they don’t want the public to figure it out.

[Texas Fossil]

Absolutely, the man who developed the PCR test says it WILL NOT test for Covid19. All it does is amplify what is in the dish.

[DEPcom]

Are those the same test they use to see if the vaccines are working?

[Grandpa Drudge]

Actually, previous studies in Israel (where they had had rapidly increasing numbers of Covid-19 infections in previously "vaccinated" people), indications are that natural immunity resulting from recovery from previous infection is somewhere between 7 and 25 times BETTER than the vaccination.