The rapid spread of the highly transmissible omicron variant is leading to record outbreaks of coronavirus. Home antigen tests provide results in under an hour, often in under 10 minutes. At-home COVID-19 tests are more convenient for consumers as they can help avoid long wait-times and lines at testing centers. The goal of ECRI’s usability evaluation, conducted in December 2021, was to determine if there were any differences in the usability of the various tests. To our knowledge, ECRI’s work is unique and adds important guidance to help our nation during a global pandemic. If and when supplies of home tests are more widely available, this report will help guide a consumer’s choice based on ease of use. When ECRI conducts its evaluations of FDA-approved medical devices, we are more likely to detect usability or safety issues than performance failures. For this reason, we decided to perform usability testing only on these at-home COVID-19 antigen tests. However, it is important to remind consumers that these devices received FDA Emergency Use Authorization (EUA), not full approval.
Because of the urgency in providing useful information to consumers as quickly as possible, ECRI selected the seven test kits based on retail availability. Tests are listed below in the order of their usability.
Bottom line: If you have a choice, it’s better to get a higher rated test.
Read the full report by ECRI here.
ECRI, an independent nonprofit organization advancing effective, evidenced-based healthcare globally, self-funded this usability study of home COVID-19 antigen tests as a public service to consumers and healthcare providers. ECRI has no financial ties to the test manufacturers and all employees abide by the strictest conflict-of-interest policies that assure our objectivity.
When ECRI evaluates medical devices that have been approved by the U.S. Food & Drug Administration (FDA), we often find usability issues or safety issues, but rarely issues with the accuracy of the device. That’s why we decided to perform usability testing on these home COVID tests. It is important for consumers to be aware that the FDA granted Emergency Use Authorization (EUA) for these products, not full approval. Management of EUAs were named the top hazard on ECRI’s 2021 Top 10 Health Technology Hazards list.
Learn more at ecri.org.
OlleyMay Safety has an inventory of FDA authorized PPE and COVID-19 rapid test kits. To order, call 212-375-6725 or complete the form below.