The U.S. Food & Drug Administration (FDA) achieved a “milestone” by issuing an emergency use authorization (EUA) for a self-administered test that can “differentiate and detect” influenza and SARS-CoV-2.
Call me skeptical based on the faulty PCR tests they rammed up millions of noses the past three years.
U.S. FDA issues emergency use authorization (EUA) for the "first over-the-counter (OTC) at-home diagnostic test" that can "differentiate" and "detect" influenza A and B, commonly known as the flu, and SARS-CoV-2
Sure it does….Just like those PCR tests accurately detected C-19.
— DailyNoah.com (@DailyNoahNews) February 27, 2023
First off, those nasal swabs can cause damage.
Also, there's no emergency.
Nobody should be testing themselves for influenza or COVID-19.
The PCR test scamdemic is how the global elites carried the COVID-19 scheme this far.
Yet, the Pharma-owned FDA will continue enabling Americans to continuously take influenza and COVID-19 nasal swabs.
The EUA test "is a single-use at-home test kit that provides results from self-collected nasal swab samples in roughly 30 minutes."
The FDA has authorized emergency use of the first over-the-counter test that can detect both Covid-19 and flu.
The test takes about 30 minutes to get results from a nasal swab and can differentiate between influenza A and B as well as Covid. https://t.co/rbgJLoAK7Z
— POLITICO (@politico) February 24, 2023
Lucira is the company that got the nod for the at-home nasal swab test kit.
It appears the FDA is attempting to prevent Lucira from going out of business.
The company recently filed for Chapter 11 bankruptcy.
Lucira Health, a maker of at-home Covid-19 tests, files for Chapter 11 bankruptcy https://t.co/TL9ClRw9ND
— Bloomberg (@business) February 22, 2023
Lucira wins FDA EUA for first at-home combined Covid/flu test — 2 days after filing for Chapter 11 bankruptcy protection. https://t.co/p67AKXkK5h
— San Francisco Business Times (@SFBusinessTimes) February 24, 2023
Per Bloomberg:
Lucira Health Inc., a publicly traded maker of at-home Covid-19 tests, filed for Chapter 11 bankruptcy on Wednesday.
California-based Lucira listed assets of about $146 million and liabilities of about $85 million in its bankruptcy petition. The company will keep operating during bankruptcy as it seeks to sell itself, according to a statement.
Lucira sells an at-home Covid test that provides “lab-quality results” in 30 minutes, according to its website. A single test is listed for $35 on the site.
Declining Covid-19 restrictions crimped demand for the tests, squeezing Lucira, Chief Executive Officer Erik Engelson said in the statement. Slower-than-expected regulatory approval for a flu test kit also hurt the company, he said.
The FDA's EUA came just in time for Lucira.
The FDA issued this release:
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single-use at-home test kit that provides results from self-collected nasal swab samples in roughly 30 minutes.
“Today’s authorization of the first OTC test that can detect Influenza A and B, along with SARS-CoV-2, is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA strongly supports innovation in test development, and we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs. We remain committed to working with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them.”
The Lucira COVID-19 & Flu Home Test is a single use test for individuals with signs and symptoms consistent with a respiratory tract infection, including COVID-19. The test can be purchased without a prescription and performed completely at-home using nasal swab samples self-collected by individuals ages 14 years or older or collected by an adult for individuals 2 years of age or older.
The test works by swirling the sample swab in a vial that is placed in the test unit. In 30 minutes or less, the test unit will display the results that show whether a person is positive or negative for each of the following: Influenza A, Influenza B and COVID-19. Individuals should report all results obtained to their healthcare provider for public health reporting and to receive appropriate medical care.
In individuals with symptoms, the Lucira COVID-19 & Flu Home Test correctly identified 99.3% of negative and 90.1% of positive Influenza A samples, 100% of negative and 88.3% of positive COVID-19 samples and 99.9% of negative Influenza B samples. Since there are currently not enough cases of Influenza B circulating to include in a clinical study, validation confirmed that the test can identify the virus in contrived specimens, and the EUA requires Lucira to continue to collect samples to study the test’s ability to detect Influenza B in real-world settings.
As with all rapid diagnostic tests, there is a risk of false positive and false negative results. Individuals who test positive for either flu or COVID-19 should take appropriate precautions to avoid spreading the virus and should seek follow-up care with their physician or healthcare provider as additional testing may be necessary. Negative results for SARS-CoV-2 and influenza B should be confirmed, if necessary for patient management, with an authorized or cleared molecular test performed in a CLIA-certified laboratory that meets requirements to perform high or moderate complexity tests. Individuals who test negative and continue to experience symptoms of fever, cough and/or shortness of breath may still have a respiratory infection and should seek follow up care with their healthcare provider.
Join the conversation!
Please share your thoughts about this article below. We value your opinions, and would love to see you add to the discussion!