Are there any COVID-19 direct antigen rapid tests being recalled?
The U.S. Food and Drug Administration has removed the COVID-19 E25Bio rapid tests because the agency has not approved them, which may produce false results and cause injury to the user.
Class I recalls are the most severe type of recall. "Use of these devices can result in serious injury or death," the FDA warned in a statement released Friday.
The tests are sold under the brand names E25Bio SARS-CoV-2 Antigen Test Kit and E25Bio COVID-19 Direct Antigen Rapid Test. Consumers who purchased the tests should discard them, and healthcare providers who administered them should consider retesting their patients.
The FDA said, "E25Bio is recalling its COVID-19 Direct Antigen Response (DART) tests for several reasons, including that these tests are being marketed and distributed to US customers without FDA clearance, clearance, or approval."
"Some of the test labels contain false claims and instructions, including a statement that misrepresents the test as FDA-approved."
The FDA said the kit could provide false positive or false negative results, which could lead to the spread of the virus or a delay in medical treatment. According to the FDA, the kits require users to obtain samples from deep in the nose or throat, which could harm consumers.
“Only trained healthcare professionals should collect these types of swab specimens to avoid serious injury,” the FDA said, adding there have been no reports of such injuries.
Most home COVID tests require the collection of a nasal swab sample.
The FDA warned consumers not to use the tests on Feb. 4 and issued the recall notice on Friday. In January, the company sent a letter to consumers advising them not to use the tests.
The FDA provides a list of approved antigen tests on its website.
E25Bio is recalling its COVID-19 Direct Antigen Response (DART) tests for several reasons, including that these tests were marketed and distributed to US customers without FDA clearance, clearance or approval.
Some test packages also contain false statements and instructions, including a statement that presents the test as FDA-approved. This is a Class I recall, the most serious type of recall specified by the FDA. Use of these devices can result in serious injury or death.
As this test has not been cleared, cleared, or approved by the FDA, there is insufficient data to prove its accuracy. This means that false negative and false positive results are possible. False negative results occur when the test does not detect the SARS-CoV-2 virus while the individual is infected. False positive results occur when a test indicates that a person is infected with SARS-CoV-2 when they are not.
Self-collection of nasopharyngeal or oropharyngeal specimens carries the potential for harm. To avoid significant harm, only trained healthcare professionals should collect these swab specimens.
The use of the affected product could have fatal consequences for health. The FDA issued a safety communication on February 4, 2022, advising users to stop using these tests.
There have been no reports of injuries, adverse health effects, or deaths related to this product.
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Product names: E25Bio COVID-19 Direct Antigen Rapid Test; Trade Name: E25Bio SARS-CoV-2 Antigen Test Kit
Product Codes and Model Numbers - View Recall Database Entry
Distribution dates: September 2020 to November 2021
Devices recalled in the United States: 73,300
Signature start date: January 27, 2022
Use of the device
The E25Bio COVID-19 direct antigen rapid test in patient samples detects proteins called SARS-CoV-2 virus antigens. These samples are obtained by one of three methods:
A swab from the nose (anterior nostrils)
Nasopharyngeal swab, which reaches the back of the throat or the middle of the throat from the back of the nose (pharynx)
Oropharyngeal swab extending just beyond the lips into the throat
Who might be affected?
Employers of the E25Bio COVID-19 direct antigen rapid test for the detection or diagnosis of SARS-CoV-2. People tested positive for SARS-CoV-2 in the E25Bio COVID-19 direct antigen rapid test. The FDA safety communication included the following recommendations for other affected parties:
Users and caregivers of the E25Bio COVID-19 Direct Antigen Rapid Test who are concerned about their test results or concerned that they may have been injured while collecting their own nasopharyngeal and oropharyngeal swab specimens should contact their health care providers.
Healthcare Professionals: If your patient has had the E25Bio COVID-19 direct antigen rapid test within the past two weeks and you suspect an erroneous result, you should consider retesting your patient with cleared SARS-CoV-2 by the FDA. If the test was performed more than two weeks ago and there is no reason to suspect an ongoing SARS-CoV-2 infection, retesting is not necessary.
Testing program administrators: Advise your testing program participants that they should no longer use the E25Bio COVID-19 Direct Antigen Rapid Test and instead use an FDA-cleared test.
WHAT EXAM TYPES ARE AVAILABLE?
There are two basic categories of evidence:
Antigen test (often called rapid test). This test detects specific protein fragments of the coronavirus. This can be done in a hospital, clinic or doctor's office. On rare occasions, the time to get results can be as short as 15 minutes.
PCR test. The PCR test is the "gold standard" for detecting SARS-CoV-2. This test detects RNA (or genetic material) that is unique to the virus and can detect the virus within days of infection, even in patients without symptoms. The test can be administered in a clinic, hospital or even in your vehicle. The average turnaround time is two to three days, although results can be achieved in as little as 24 hours. When demand is high, it can take a week or more to see results.
WHO SHOULD GET A RAPID TEST?
Rapid tests are thought to be most accurate when given to patients with symptoms of COVID-19. Although the rapid test can provide results extremely quickly, the accuracy of the results cannot be guaranteed.
WHAT DOES FALSE NEGATIVE OR FALSE POSITIVE MEAN?
In people without symptoms, the rate of false negatives (my test is negative, but I have the disease) can reach 50%. This could have huge implications for our attempt to limit the spread of COVID-19.
False positive rates, where a person tests positive but does not have the condition, are quite low. Therefore, if a rapid test reveals a positive result, you are more likely to have the disease.
WHAT IF MY RAPID TEST IS NEGATIVE BUT I STILL HAVE SYMPTOMS?
The current suggestion is to do a confirmatory test (the PCR test) if you have persistent symptoms and a negative rapid test. This is especially true if you have been exposed to a high risk situation. High-risk exposure is defined as more than 15 minutes of contact with a COVID-positive person within 24 hours and within 6 feet of that person.
HOW CAN I HELP PREVENT THE SPREAD OF COVID-19?
Put on a mask.
Social Distancing - Maintain a distance of 6 feet.
Hands should be washed frequently with soap and water for at least 20 seconds.
Use a hand sanitizer that contains at least 60% alcohol.
It is not recommended to touch your eyes, nose and mouth with dirty hands.
Avoid close contact with sick people.
Stay home if you are sick.
Use a tissue to cover a cough or sneeze.
Clean and disinfect frequently touched surfaces and objects.
As always, if you are unsure which COVID-19 test is right for you, please consult your healthcare professional.
For more information visit https://www.tibdiagnostics.com/










