Antibody testing is an extremely important measure that would hopefully lead us to reopen the entire country and recovering the economy. However, the antibody testing business is referred to as the Wild West, as plenty of these tests on the market are completely inaccurate and caused a mess in the health care system.
At the beginning of the pandemic, the FDA (Food and Drug Administration) had low criteria due to the emergency of the situation.
Rushing towards fast results turned out to be so confusing, as none of the expected happened. Instead of detecting who has immunity to the virus, we ended up with false-positive results.
Until now, any manufacturer that claimed their antibody tests are accurate was getting a green light from the FDA, which seemed quite irresponsible.
Working without filters, and trusting the word of the companies whose final goal is personal benefit didn’t work out, so now we are at the start point again.
Finally, the FDA decided to stiffen its rules and don’t let just whomever to sell antibody tests. From now, antibody tests manufacturers need to meet all the safety standards of the FDA if they want their product to remain on the market.
At the moment, chances that postive antibody test is wrong are 85%, which is a devastating result.