Should You “Self-Test”? Only if you WANT to.
The Abbott antigen test was mailed to Vermont Representatives.
People entering the building next week (January 4th the House convene at 10 am) are directed to test twice. This should be highly optional.
Here is what we know about this test:
The BinaxNOW EUA test was “emergency-use-authorized” (not FDA approved) just months ago on March 31, 2021. The EUA letter waived requirements for Good Manufacturing Practices (see page 5).
The label and more detailed Instructions for Use indicate that “The emergency use of this product 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.”
So how was this test clinically validated?
CDC MMWR reported a low sensitivity in asymptomatic participants (35.8%). (Prince-Guerra JL, et al. Evaluation of Abbott BinaxNOW rapid antigen test for SARS-CoV-2 infection at two community-based testing sites-Pima County, Arizona, November 3–17, 2020. Morb. Mortal Wkly Rep. 2021;70:100–105. doi: 10.15585/mmwr.mm7003e3)
Another evaluation by Emory scientists out of Georgia recently published in Nature reported Clinical performance of 297 staff-collected anterior nasal (AN) swabs (77 positive), the BinaxNOW test sensitivity was between 64–82% with approx 3% false positive rate; sensitivity for self or parent collected was lower at 37–76% and specificity as low as 79% (20+ % false positive rate) Full study: https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC8285474/pdf/41598_2021_Article_94055.pdf
Why are we testing healthy people with a test that has poor performance in that group of people (asymptomatic people)?
Not trying to be difficult here. But some suggest we should continue isolating and quarantining healthy people and using these tests will just create more fear and confusion.
Those who feel they must have social isolation, vaccines and masks to protect themselves certainly can choose to do this. Tests should be used by qualified doctors in the diagnosis of a disease, to help them guide treatment. Not by anyone willy-nilly. This would be a waste of money.
Let’s take health decisions that are best for each individual. We are all unique. We are social creatures but we do not participate in experimental treatments to protect others. The vaccines might protect the person vaccinated – they do not protect others. It is technically possible for the viral load in a vaccinated person to be the same as in a non vaccinated (symptomatic) person, and also possible for viral genetic fragment to be present in the absence of disease. Same for antigen, protein fragment, in our mucous membranes. Without symptoms, positive results only create fear and confusion and do not help in patient care.
The C19 genetic vaccines do not prevent a person from catching, transmitting, and/or getting ill from covid. So even if you wanted to throw ‘that freedom thing’ aside, requiring vaccine passports makes no sense. Covid is with us. All of us.
Randomly testing healthy people, or pushing those not treated with vaccine that does not stop transmission to have to test to prove they have not been mysteriously harboring illness seems like belief not science. A witch hunt, especially with a low sensitivity test, in the absence of symptoms or actual presence of clinical disease.
Nobody should be bullied into disclosing private medical information. Vaccine status. Test status. This is a free country, yes? Then you need to be able to say “no thank you.”
Jennifer Stella