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FDA!!! Release the Rapid Antigen Contagiousness Tests!!!,

…a Petition for Access in the United States.

We need access to fast and inexpensive $1-2 over the counter, COVID-19 rapid CONTAGIOUSNESS tests, that gives results in 10-15 minutes from the comfort of HOME, not inside a place of business or an educational institution but AT HOME.

*SPIT-ONLY TESTS DO EXIST*

You’ve likely heard of PCR testing, which is currently used to diagnose a person with covid-19, but it is expensive at $100+ for a one time use self-testing device sold over the counter for same day results at home, or you can opt for lab results which takes days to receive and DOES NOT tell us what we REALLY need to know,

“AM I CONTAGIOUS AND SPREADING COVID-19 RIGHT NOW?” � at the end of the day, that’s ALL we want to know.

By comparison to PCR tests, an easily accessible RAPID ANTIGEN CONTAGIOUSNESS TEST provides FAST results (10-15 minutes) that can be taken AT HOME, where results are 99.99% accurate when testing for contagiousness when viral load in the body is high enough to be contagious/transmitting to others.

A positive test can easily be confirmed with another competing rapid antigen contagiousness test for 100% assurance of contagiousness, no need for a confirmatory PCR test.

These rapid antigen contagiousness tests will help identify symptomatic and asymptomatic people.

Asymptomatic is a person that has little to no symptoms but still has viral load high enough to infect others. This happens as covid-19 has been shown to down-regulate genes related to immune response , like a fever for example, during the first couple days when someone is actually in the contagious zone. A person is highly contagious when they are in the contagious zone, a ~6 day period.

Used on a regular basis (serial testing) 2 times a week or when needed, these rapid antigen contagiousness tests serve as a CRITICAL tool to stop new transmission chains at their root, stopping outbreaks before they become pandemics. Put the power back in your hands.

The FDA must act in conjunction with the CDC to create an independent comparative evaluation of rapid antigen contagiousness tests via a Presidential Executive Order, which would with the stroke of a pen, redefine these simple life saving paper test strips from a “diagnostic device” like a PCR test to a “public health tool” labelled as a contagiousness test.

Access to inexpensive at-home contagiousness tests, can help individuals make informed decisions, to “know before they go” and is a critical strategy for controlling the spread of COVID-19 from the root at home, not inside of a place of business or educational institution, but AT HOME, yet the United States is still not using them effectively or providing the proper messaging on their use as contagiousness tests.

No single testing regimen or prevention technique is entirely 100% effective on its own, but frequent home testing will catch infectious asymptomatic and symptomatic people, who might not otherwise  go out to get tested or who enter the contagiousness zone after receiving a negative PCR result after days of waiting.

We are approaching 2 years into the heart of the pandemic and the FDA has STILL only authorized a couple over the counter rapid antigen at-home contagiousness test, with little competition with the potential of lowering prices on these tests for everyone, the price points today are out of reach for the vast majority of Americans wanting to use them with any regularity.

Manufacturers were able to sell them directly to the US population for as low at $1.50 each, but access to manufacturers without EUA approval has been closed off since the start of 2021.

There is currently an enormous volume of Emergency Use Authorization (EUA) applications sitting at the FDA from rapid antigen contagiousness test manufacturers, many manufacturers have been waiting for EUA approvals for over a year now, no more waiting. The manufacturing capacity is available nationally and internationally, we just need access.

We request the FDA to answer the following 5 questions in a timely manner:

1. Does the FDA currently have the authority to conduct an independent evaluation of rapid antigen tests as described? Is additional Congressional Authorization needed?

2. Would the FDA be able to conduct such an evaluation of already authorized tests, in addition to the dozens of tests submitted to the FDA awaiting authorization?

3. Does the FDA currently have plans to undertake a standardized evaluation of rapid antigen tests?

4. Could evaluating comparative effectiveness of all submitted tests at the same time help reduce the backlog of EUA submissions?

5 Would applying the “serial testing” rule where tests must be sold 2+ to a pack, expedite the EUA approval process?

This pandemic has been long and hard on all of us.  Having accessible, inexpensive rapid antigen contagiousness testing at home is key to allowing our economies to remain open and our families to stay safe.

The signers of this petition look forward to your timely response.

****RESOURCES AND STUDIES SECTION****

Video: Learn how rapid contagiousness tests make a difference? https://youtu.be/1qFtAm4lUAw

Video: The problem with PCR sensitivity: False infectious - False negatives as Fase positives: https://youtu.be/4vvgefwKgSU

Video: FDA doesn’t like cheap covid tests: https://youtu.be/uYCwe0XhDZ4

Example of a spit/saliva-only test (NO SWABS): https://youtu.be/TKcwNYBuaSo

“In a recent study by Pilarowski et al. in the peer-reviewed journal Clinical Infectious Diseases, (https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa1890/6052342 ) researchers in California assessed BinaxNOW in a community-based setting in people of all ages with and without symptoms. They demonstrated high sensitivity and specificity for BinaxNOW, including in asymptomatic people and in children. Among 102 people who were asymptomatic or whose symptom onset was greater than 7 days before testing, sensitivity for a Ct cutoff of 30 was 100% and specificity was 98.9%. As Ct counts increased to 35 (therefore reflecting less viral load) performance remained high in asymptomatic people of all ages, showing 97.5% sensitivity and 99.7% specificity.”

What’s the difference between sensitivity vs specificity?

Sensitivity refers to a test's ability to designate an individual with disease as POSITIVE. A highly sensitive test means that there are FEW false negative results, and thus FEWER cases of disease are missed. The specificity of a test is its ability to designate an individual who does NOT have a disease as negative.

Study that demonstrates that Covid-19 down regulates immune response: https://www.frontiersin.org/articles/10.3389/fimmu.2020.01441/full

RapidTests.org - an all-volunteer group advocating for rapid tests to be made legal and widely available in our communities.