Author: Kepczynski, Casey M.; Genigeski, Jaelin A.; Koski, Renee R.; Bernknopf, Allison C.; Konieczny, Alison M.; Klepser, Michael E.
Title: A Systematic Review Comparing At-Home Diagnostic Tests for SARS-CoV-2: Key Points for Pharmacy Practice, Including Regulatory Information Cord-id: 1jwrzvn5 Document date: 2021_6_12
ID: 1jwrzvn5
Snippet: Objectives Home-based rapid diagnostic testing can play an integral role in controlling the spread of COVID-19. This review aimed to identify and compare at-home diagnostic tests that have been granted Emergency Use Authorizations (EUA) and convey details about COVID-19 diagnostic tests, including regulatory information, pertinent to pharmacy practice. Methods Food and Drug Administration (FDA) online resources pertaining to COVID-19 tests, EUAs, and medical devices were consulted, as well as li
Document: Objectives Home-based rapid diagnostic testing can play an integral role in controlling the spread of COVID-19. This review aimed to identify and compare at-home diagnostic tests that have been granted Emergency Use Authorizations (EUA) and convey details about COVID-19 diagnostic tests, including regulatory information, pertinent to pharmacy practice. Methods Food and Drug Administration (FDA) online resources pertaining to COVID-19 tests, EUAs, and medical devices were consulted, as well as linked resources from the 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. Literature Selection Studies were included if they were performed at home or were self-collected (or collected by a parent or guardian for patients under 18 years of age), and evaluated the positive percent agreement (PPA) and negative percent agreement (NPA) for the clinical diagnosis of SARS-CoV-2 virus. Results Limited data has 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 based on positive percent agreement ranging from 83.5% to 97.4% and negative percent agreement ranging from 97% to 100%. Conclusions The 9 SARS-CoV-2 home tests demonstrated satisfactory performance in comparison to laboratory real time reverse-transcription polymerase chain reaction (RT-PCR) tests. The convenience and ease of use of these tests make them well-suited for home-based rapid SARS-CoV-2 testing.
Search related documents:
Co phrase search for related documents- Try single phrases listed below for: 1
Co phrase search for related documents, hyperlinks ordered by date