The US food and drug administration, or FDA, is regularly warning the people working in lusys laboratories to stop the antigen test against COVID-19. Lusys Laboratories Covid 19 Antigen Test and Lusys Laboratories Covid 19 IgG/IgM Antibody Test have been in use for the past few months.
But their results are not adequate or sufficient. The FDA says that the results of these tests are not always satisfactory and that there is a higher risk of getting false results when using these kinds of tests.
Moreover, these tests are unauthorized, uncleared, and disapproved by the FDA for any kind of distribution or use in the United States. Nevertheless, these tests are marketed and supplied under the names EagleDx and Luscient Diagnostics, respectively.
The FDA believes that the selling of these tests is conducted only for the purpose of laboratory and home-testing purposes.
Lusys Laboratories Covid 19 Antigen Test And Possible Associated Risks
There Are Potential Risks That Are Associated With The Lusys Laboratories Covid-19 Antigen Test, Such As:
Getting False-Negative Antigen Test Result
This means that even when a person is infected with the virus COVID-19, the test may show that he is not infected with the virus. The chances of getting a false result are very high in this test.
And, as a result of this false result, there may be a delay in his treatment for SARC-AoV-2, which could lead to a serious illness or even death. Moreover, when the result is false or negative, the person cannot be isolated from people and their families, thereby spreading the infection among them.
So, to decrease the spread of viruses, it is important to know the true result rather than a false result, and this test fails to do so.
Getting False-Positive Antigen Test Result
This simply means getting a result that states that the person is affected by COVID-19 when they are not actually affected. In other words, the test will indicate that a person is positive even when they are not afflicted by any of the 19 viruses in real life. This could result in a false relationship with the individual, which could make him feel unwell or frail.
Fda Response To Lusys Laboratories’ Covid-19 Antigen Test
Since the test’s inception, the FDA has been regularly monitoring its performance and reporting a large number of issues with the test’s performance or results. The FDA was regularly helping people or making them aware of this false result that could lead them to serious injury or even death.
The FDA even informs the public that this is an unauthorized, unapproved, or unclear test in the eyes of the FDA and legal entities. The FDA has been continuously giving statements to educate test users, caregivers, healthcare professionals, and the public to avoid these kinds of false tests and keep them safe.
The FDA also opened up with two measures for the public, such as:
- If you ever think that you are facing a problem with the SARS-CoV-2 test, then you can report the same through the Medwatch voluntary reporting form.
- If you think that your device is not working properly and there is something wrong with it, then you can report it to the MedWatch voluntary reporting form.
In Addition, The Fda Has Issued Two Important And Knowledgeable Statements About Lusys Laboratories’ Covid 19 Antigen Test. It Says That:
The San Diego-based company is recalling its COVID-19 antigen test once more, but they do not have the necessary authorization or approval to sell it on the market.
As a result, there are no safety issues or authorizations if they are selling or distributing it in the United States. Even though it is assumed that they are offering it for use in laboratories and at-home healthcare.
“In its second statement, it failed to provide appropriate validation for the accuracy of its test.” There is no actual data that states or proves that the test they are performing is safe, secure, and accurate.