Unreliable Coronavirus Antibody Tests Leads to FDA Crackdown
Medical experts who discuss the coronavirus pandemic note that increased testing is essential to any return to normalcy. This call for increased testing has resulted in a glut of new antibody tests, many of which have been determined to be defective or unreliable. As a result, the Food and Drug Administration (FDA) is now cracking down on these antibody tests, requiring FDA authorization before they can be sold on the market.
When it comes to the coronavirus, there are two primary forms of tests: diagnostic tests that test if you currently have the virus, and antibody tests that determine if you had the virus in the past. While diagnostic tests are essential due to how much they are needed for diagnosing patients, antibody tests are also important for determining how far the virus has spread, and whether someone might be potentially immune as a result. This is particularly important for the coronavirus as many people who become infected by the disease are either asymptomatic or only show mild symptoms that can be easily mistaken for other illnesses, making tracking the disease without testing difficult.
This imminent need for increased testing has been filled by dozens of companies all producing their own antibody tests, all without FDA guidance or approval. Perhaps unsurprisingly, many of these antibody tests are defective or unreliable, with false positives being a common problem for these products. This is particularly dangerous because a false positive on an antibody test can give someone false hope that they are immune from the coronavirus, causing them to engage in riskier behavior than they normally would and resulting in a higher risk of becoming infected or unintentionally spreading the disease.
To address this issue, the FDA has begun cracking down on producers of these antibody tests. Whereas before they could simply produce antibody tests freely, anyone who now wishes to produce and sell such tests must file for authorization from the FDA, like how many other kinds of medical equipment must be authorized before they can be sold. This will hopefully cut down on the flood of poor-quality antibody tests and give doctors better tools to fight and track the spread of the coronavirus.