At-Home Respiratory Virus Testing: Regulatory Landscape and Performance After the Pandemic
This mini-review examines the OTC testing landscape for respiratory viruses that emerged from the COVID-19 pandemic, covering antigen and nucleic acid detection tests authorised for home use under FDA Emergency Use Authorization. Comparison studies show favourable concordance between OTC and centralised laboratory results, suggesting a durable role for consumer self-testing in healthcare. The authors discuss regulatory and reimbursement frameworks, sample collection challenges, and public health reporting limitations.
The original study
At-home testing for respiratory viruses: a minireview of the current landscape.
- Authors
- Smy L, Ledeboer NA, Wood MG
- Journal
- Journal of clinical microbiology
- Type
- Journal Article, Review
- PMID
- 38436246
Original abstract
The landscape of at-home testing using over-the-counter (OTC) tests has been evolving over the last decade. The United States Food and Drug Administration Emergency Use Authorization rule has been in effect since the early 2000s, and it was widely employed during the severe acute respiratory syndrome coronavirus 2 pandemic to authorize antigen and nucleic acid detection tests for use in central laboratories as well as OTC. During the pandemic, the first at-home tests for respiratory viruses became available for consumer use, which opened the door for additional respiratory virus OTC tests. Concerns may exist regarding the public's ability to properly collect samples, perform testing, interpret results, and report results to public health authorities. However, favorable comparison studies between OTC testing and centralized laboratory test results suggest that OTC testing may have a place in healthcare, and it is likely here to stay. This mini-review of OTC tests for viral respiratory diseases will briefly cover the regulatory and reimbursement environment, current OTC test availability, as well as the advantages and limitations of OTC tests.