A systematic review comparing at-home diagnostic tests for SARS-CoV-2: Key points for pharmacy practice, including regulatory information.

BACKGROUND

Home-based rapid diagnostic testing can play an integral role in controlling the spread of coronavirus disease 2019 (COVID-19).

OBJECTIVES

This review aimed to identify and compare at-home diagnostic tests that have been granted Emergency Use Authorizations (EUAs) and convey details about COVID-19 diagnostic tests, including regulatory information, pertinent to pharmacy practice.

METHODS

The Food and Drug Administration (FDA) online resources pertaining to COVID-19 tests, EUAs, and medical devices were consulted, as were linked resources from FDA's webpages. Homepages of the 9 COVID-19 home tests with EUAs were comprehensively reviewed. PubMed literature searches were performed, most recently in May 2021, to locate literature about the identified home tests, as were searches of Google Scholar, medRxiv, and bioRxiv. Studies were included if they were performed at home or if subjects self-tested at study sites. Samples were collected by a parent or guardian for patients under 18 years of age. Positive percent agreement (PPA) and negative percent agreement (NPA) for the clinical diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus was evaluated.

RESULTS

Limited data have been published for these home tests given that they are available through EUAs that do not require clinical trials. Fifteen studies were located from searching the literature, but only 2 met the inclusion criteria. Review of the home tests' websites yielded a single study for each test, with the 3 BinaxNOW platforms using the same study for their EUAs. The 9 COVID-19 home tests with EUAs as of May 7, 2021, include 3 molecular tests and 6 antigen tests. These tests had similar performance on the basis of PPA ranging from 83.5% to 97.4% and NPA ranging from 97% to 100%.

CONCLUSION

The 9 SARS-CoV-2 home tests demonstrated satisfactory performance in comparison with laboratory real time reverse-transcription polymerase chain reaction tests. The convenience and ease of use of these tests make them well-suited for home-based rapid SARS-CoV-2 testing.