In the midst of the pandemic, many companies have started marketing diagnostic and serological (antibody) COVID-19 tests directly to consumers. Such direct-to-consumer (DTC) tests can be initiated by consumers, typically through the company’s website. The sample can be collected at home or in a laboratory, with no or little direct involvement from a health care provider. About a dozen companies have received emergency use authorization for diagnostic DTC COVID-19 tests and at least two for serological testing.
In an article published in the Journal of Law and the Biosciences, researchers argue that while this type of testing may have a number of benefits (e.g., expanding access to testing), it also raises significant ethical and regulatory concerns, which become particularly urgent due to the scale of the present pandemic.
Concerns over test accuracy, and the absence of health care professional carrying a greater risk of misinterpretation of results are evident, as well as companies making unsubstantiated and often fraudulent claims, such as falsely stating that their tests have been approved by FDA or that their serological tests can diagnose the disease. The massive amount of information (and misinformation) about COVID-19, and the quickly changing landscape, may make it particularly challenging for consumers to differentiate between legitimate tests and fraudulent products.
This story is by Louiza Kalokairinou. Read more at Penn LDI.