FDA issues severe COVID-19 serological test warning

The U.S. Food and Drug Administration (FDA) has warned COVID-19 serological testing manufacturers not to exaggerate the usefulness of their products or claim federal approval, and warned that the significance of such a diagnosis may be premature,media Slash Gear reported. Unlike the broader testing process, serological tests look for the new coronavirus itself in a patient’s sample, rather than the body’s immune response to the infection.

FDA issues severe COVID-19 serological test warning

This is an important distinction, although many people seem to confuse it. For example, by detecting the presence of the virus itself, you can see if the patient is currently infected with COVID-19.

However, by looking for an immune response— specifically, an antibody or a protein present in the blood, when the body responds to an infection, an antibody or protein appears — you can potentially know if the patient is infected with the new coronavirus, even if they are not currently infected. This is important to assess the population, to see how spread COVID-19 is, and to see how many people may be immune to future infections.

“In the early stages of infection, antibodies may not be detected when the body’s immune response is still in place,” the FDA explained. “This limits the effectiveness of the test for the diagnosis of COVID-19 and why it should not be used as the sole basis for diagnosing COVID-19. “

COVID-19 Serological testing is important, but not overnight

This time-sensitive problem is the reason why extensive testing cannot rely solely on serological methods. Currently, the FDA has authorized a single serological test under the Emergency Use Authorization (EUA) procedure, allowing the early application of drugs and testing processes during a new coronavirus pandemic. This is why Cellex’s qSARS-CoV-2 IgG/IgM Rapid Detection Kit, designed for approved laboratory use, is authorized.

Apparently, more than 70 test developers have notified the FDA that they have serological diagnostics available. For now, however, they have not yet been authorized, and none of them can claim approval from the agency. “However, some companies falsely claim that their serological testing programs have been approved or authorized by the FDA, or that they can diagnose COVID-19,” the FDA said. “The FDA will take appropriate action against companies that falsely claim or market inaccurate and reliable testing programs. “

Without consistent COVID-19 testing, it is difficult to assess its response

At least 42 u.S. states have issued some kind of “home order.” About 95 percent of the U.S. population is believed to be affected by one of the orders, although several states continue to refuse to enact such measures. The challenge for legislators is to understand how these efforts affect the progress of COVID-19. Without consistent and extensive testing, it is virtually impossible to determine the extent to which the new coronavirus affects the population. On the contrary, only mortality figures are used as the basis for decision-making.

As of the time of writing, there had been 429,052 confirmed cases of new coronavirus in the United States and 14,695 deaths. This includes not only the 50 states, but also the District of Columbia, Puerto Rico, Guam, the Northern Mariana Islands and the United States Virgin Islands.

FDA issues severe COVID-19 serological test warning