The COVID-19 outbreak in the United States has prompted many companies to enter the pharmaceutical market to offer tests for detecting coronavirus infection. The US Food and Drug Administration (FDA) was very cautious though and halted them. In contrast, when it came to providing coronavirus antibody tests, it allowed more than 90 to go on the market without previously reviewing them. Companies are offering people tests for the coronavirus antibody that they can perform in their own homes.
In this respect, the Washington Post, like many other media, published an article last Monday about the issue, entitled Coronavirus testing at home: What you need to know. Below are some of the points that we consider of bioethical interest.
The article begins with an explanation of the coronavirus antibody tests: “Antibody, or serological, tests are designed to identify people who may have overcome COVID-19, including those who had no symptoms, and developed an immune response. They are not designed to detect active infections. Some officials tout the blood tests as a way to reopen the economy by identifying individuals who have developed immunity and can safely return to work.” The author continues: “But many scientists, as well as the World Health Organization, say evidence is lacking that even high-quality antibody tests can prove someone has immunity from the novel coronavirus and is not at risk of being reinfected.”
“The emergence of dozens of tests never reviewed by the FDA — many of which are being aggressively marketed — could confuse doctors, hospitals, employers and consumers clamoring for the products, according to critics who say the agency’s oversight of the tests has been lax. The questions are taking on special importance as federal and state officials debate strategies, including using serological testing, to help determine when they can end state and local lockdowns.”
Coronavirus antibody testing. ‘People should be very cautious’
The article concluded with an FDA statement, “On Thursday, during an interview with Washington Post Live, FDA Commissioner Stephen Hahn said, ‘people should be very cautious’ about tests that have not undergone the rigorous process of getting emergency use authorization from the agency. The FDA over the weekend said four tests have gotten such authorizations: Cellex, Chembio Diagnostic Systems, Ortho Clinical Diagnostics and Mount Sinai Laboratory.”
How is the Administration reacting? The article gives an example: “Some state and local health departments also have warned consumers and doctors to avoid tests that haven’t been authorized. In San Diego County, officials shut down a pop-up antibody testing site at a community college, citing a lack of documentation about the test.” Nevertheless, unvetted tests continue to be marketed.