- This novel product is called the Lucira COVID-19 & Flu Home Test and is now available for purchase without a prescription in the United States.
- It has the ability to differentiate and detect influenza A and B, as well as the SARS-CoV-2 virus, in an average time of 30 minutes.
- So far, Cofepris has not reported whether it plans to authorize this home test that detects influenza and Covid-19 for sale in Mexico.
The pandemic is not over and it is very unlikely that it will ever go away. The number of deaths continues to decline but no country has yet managed to completely eradicate this disease. For this reason, to reduce risks, there is already a Over-the-counter home test that detects both Covid-19 and influenza.
This over-the-counter (OTC) test is called Check COVID-19 & Flu Home Test and has the ability to differentiate and detect the influenza A and B, as well as the SARS-CoV-2 virus. While the most important thing is that it is the first of its kind to obtain authorization from the United States Food and Drug Administration (FDA) for its commercialization.
How does it work?
Regarding its characteristics, it is a single-use test that provides results for self-collected nasal swab samples in approximately 30 minutes.
“Today’s authorization of the first over-the-counter test that can detect influenza A and B, along with SARS-CoV-2, is an important milestone in providing greater consumer access to diagnostic tests that can be completely at home,” said Jeff Shuren, who is director of the FDA’s Center for Devices and Radiological Health.
For its part, the agency was in favor of supporting innovation in test development. She also said she is eager to continue advocating for greater access to home infectious disease testing to support public health needs.
The home test for influenza and Covid-19 It was designed for people with signs and symptoms of a respiratory infection. No prescription is required for purchase because it is OTC and the screening can be done entirely at home with nasal swab samples.
Today we issued an emergency use authorization for the first over-the-counter at-home diagnostic test that can detect both the flu and #COVID19. The test provides results from self-collected nasal swab samples in roughly 30 minutes.
Learn more ➡️https://t.co/LVJLsWxQVk pic.twitter.com/S2RsJb0TNv
— U.S. FDA (@US_FDA) February 24, 2023
The test works by rotating the sample swab in a vial that is placed in the test unit. In 30 minutes or less, the test unit will display results indicating whether a person is positive or negative for each of the following infections: Influenza A, Influenza B, and COVID-19. Individuals should report all results obtained to their health care provider in order to receive appropriate care.
Test Efficiency
In people with symptoms, the Check COVID-19 & Flu Home Test correctly identified 99.3% of the negative and 90.1% of the positive influenza A samples. In addition, 100% of the negative and 88.3% of the COVID-19 positive samples and 99.9% of the negative influenza B samples .
Since there are currently not enough circulating influenza B cases to include them in a clinical study, validation confirmed that the test can identify the virus in contrived samples.
As with all rapid diagnostic tests, there is a risk of false positive and false negative results. People who test positive for influenza or COVID-19 should take appropriate precautions to prevent the spread of the virus and should seek follow-up care with their physician or health care provider because additional testing may be necessary.
Negative results for SARS-CoV-2 and influenza B must be confirmed, if necessary, with a licensed or approved molecular test performed in a certified laboratory that meets the requirements for high or moderate complexity testing.
People who test negative and continue to have symptoms such as fever, cough, and/or shortness of breath may still have a respiratory infection and should seek follow-up care with their health care provider.
Will it ever come to Mexico?
For now, it has not been notified if this new home test to detect influenza and Covid-19 could reach Mexico. In this sense, in order to be marketed, the prior endorsement of the Federal Commission for the Protection against Sanitary Risks (Cofepris) is required.
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