Getting tested for infection with SARS-CoV-2, or the coronavirus, is an important way to help reduce transmission of the virus. If you prefer to get tested in the comfort and convenience of your own home instead of going out for a PCR test, several rapid home COVID-19 tests are now on the market.
With some home tests, you receive a kit in the mail that gives you instructions on how to perform the nasal swab. You then ship the swab to a lab to receive your results.
Other home tests can be purchased from online retailers or local pharmacies and provide results within minutes.
One home COVID-19 test option is the Flowflex COVID-19 Antigen Home Test made by ACON Laboratories. The
However, another of the tests manufactured by ACON – the Flowflex SARS-CoV-2 Antigen Rapid Test (self-test) – has not been cleared by the FDA and has been recalled by the manufacturer.
Read on to learn more about the Flowflex COVID-19 Antigen home test, including its safety, customer reviews, and more.
Like other over-the-counter COVID-19 tests, Flowflex requires you to take a sample from your nasal passage using the sterile swab provided. According to the company, Flowflex provides results in 15 minutes and is safe to use for children as young as 2 years old.
One of the other tests created by ACON – the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) – was distributed in the United States as a counterfeit product, according to the
This test is only authorized for sale in Europe and other markets, and ACON has not imported it into the United States.
In early 2022, the product was recalled in the United States. It cannot be legally imported, distributed, or used in the United States because it has not been approved, cleared, or cleared by the FDA.
This test is different from the Flowflex COVID-19 Antigen Home Test, which is still available for purchase in the United States and has received an EUA from the FDA.
The FDA has also issued a
Although there have been no reports of death, injury, or adverse health consequences, the FDA is concerned about the risk of false results when using this unlicensed test.
Be sure to check the packaging before purchasing a Flowflex test. The Flowflex COVID-19 Antigen Home test, delivered in a white box, is cleared by the FDA and can be used in the United States.
It is important to use FDA cleared or approved tests. COVID-19 antigen tests in the United States that are not FDA-approved may pose a significant risk. Use of these tests may result in inaccurate test results, such as false negative or false positive results.
False negative results could lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2. It could harm people by spreading the virus unknowingly and potentially causing serious illness and death.
False positive antigen test results can delay both the correct diagnosis and the treatment of the real cause of a person’s illness, which could be another virus that is not SARS-CoV-2.
Although the Flowflex COVID-19 Antigen Home Test is not officially FDA approved, the FDA has given it a
Online reviews of the Flowflex Home Antigen Test are overwhelmingly positive.
Reviewers report that the test is very accurate, but note that it is very important to follow the instructions exactly to get accurate results. Others appreciate the quick results and note that the test is affordable and convenient.
From Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) has been recalled in the US, it is no longer sold online and there are very few reviews directly related to it.
Overall, ACON Laboratories receives an average of 4 stars from sites like SVC and Target. While some customers say the test was easy and quick to use, others complain that their tests were missing parts, making it impossible to use the product.
The FDA has not received any reports of death, injury, or adverse health consequences associated with these tests. However, a Flowflex product has been recalled in the United States, which means it is not safe to use.
The FDA encourages you to report any concerns through the MedWatch Self-Report Form. This form is a place where consumers can report observed or suspected adverse events for medical products for human use. These reports help the FDA identify risks to medical products.
The Flowflex COVID-19 Antigen home test is available for purchase at many online retailers, such as:
If you’d rather opt for an at-home COVID-19 test that isn’t made by Flowflex, here are a few other options that are also endorsed by Healthline.
Everlywell’s COVID-19 home test allows you to easily test for SARS-CoV-2 infection whether or not you have symptoms. Collect your sample at home (a lower nasal swab) and ship for free, then receive secure digital results within 24-48 hours of your sample being received by the lab.
A telehealth consultation is available to guide you through your next steps. This FDA-cleared test is suitable for people aged 18 and over.
This home COVID-19 test can be ordered online and shipped for free. You can complete the easy-to-follow process of swabbing your sample, then use the UPS next day return airmail shipping label provided to return your sample to the lab.
Once your sample has been analyzed, you will receive the results within 24 to 72 hours.
Obtain a COVID-19 PCR test home collection kit from Labcorp and collect your nasal swab before returning it to the lab using the FedEx depot.
The lab will perform a PCR test on your sample and provide the results within 1-2 days. This test is safe for children 2 years and older.
Why has Flowflex been recalled?
The Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Test) has not been cleared, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unlicensed test.
Meanwhile, the Flowflex COVID-19 Antigen home test has not been cleared by the FDA but has received an EUA. This means it is safe to use.
What are the consequences of a false negative COVID-19 test?
A false negative result
False negative results may also lead to further spread of SARS-CoV-2, as measures to limit exposure to someone with the virus may not be taken.
How accurate are COVID-19 home tests?
Home COVID-19 tests detect current infection and are very reliable, according to the
Although the Flowflex COVID-19 Antigen Home Test has not been FDA cleared, the FDA has cleared it, which means it is safe to use.
However, the Flowflex SARS-CoV-2 Antigen Rapid Test (self-test) has been recalled in the United States because it is not approved or cleared by the FDA.
If you want additional options for an at-home COVID-19 test, try one of our recommended alternatives.