The U.S. Food and Drug Administration (FDA) has released a guide to consumers warning about counterfeit COVID-19 diagnostic tests. Although the agency stated that they have not found any counterfeit tests in government-distributed centers, the agency stated in late April that it is “aware of counterfeit at-home over-the-counter (OTC) COVID-19 diagnostic tests being distributed or used in the United States.”
The FDA defined a counterfeit test as “tests that are not authorized, cleared, or approved by the FDA for distribution or use in the United States, but are made to look like authorized tests so the users will think they are the real, FDA-authorized test.” The danger of these counterfeits is that their accuracy is not established.
The FDA explained that a false negative from these tests would lead an individual to behave as though they were not infected with COVID-19, not only potentially spreading the disease to other healthy people, but also resulting in that infected person being housed with other non-infected people in health care facilities, long-term care homes, or other facilities where potentially vulnerable individuals live in close proximity to one another.
According to the FDA, a false positive would also be problematic. This outcome could lead to the individual being treated for COVID-19 rather than their actual illness and may end up with them becoming infected with COVID-19 in addition to their real illness if they are housed with other positive patients.
To help consumers, the FDA has compiled a list of authorized at-home diagnostic tests. The agency has information about approved tests, Letters of Authorization, and authorized labeling in their “In Vitro Diagnostics EUAs: Tables of IVD EUAs.”
In their guide, the FDA listed a number of signs that an at-home over-the-counter COVID-19 test may be a counterfeit. Those signs listed by the FDA are:
- Poor print quality of the images or text on the outside of the box label for the test.
- Poor quality of text in the instructions for use included in the box.
- Missing information on the outside of the box such as the lot number, expiration date, barcode, or QR codes.
- Grammatical or spelling errors in the labeling.
- Components of the kits do not match up with the descriptions such as missing Instructions for Use, missing or unfilled components, or a different number of components than listed.
- Tradename for the test printed on component or box labels that differ from the authorized labeling found on the FDA website: “At-Home OTC COVID-19 Diagnostic Tests”.
- Box label or printed instructions for use that look different from the authorized labeling found on the FDA website.
In their conclusion, the FDA stated that the agency is working with manufacturers to address the safety issues posed by counterfeit tests. The agency also stated that it will work to keep consumers informed of new developments that arise.