Elsevier

Journal of the American Pharmacists Association

Volume 61, Issue 6, November–December 2021, Pages 666-677.e2
Journal of the American Pharmacists Association

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

https://doi.org/10.1016/j.japh.2021.06.012Get rights and content

Abstract

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.

Section snippets

Regulatory matters

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) established national quality standards for nonresearch laboratory testing performed on human-derived specimens. Under these regulatory standards for laboratory tests performed for the purposes of health assessment or for “diagnosis, prevention, or treatment,”7, 8, 9 CLIA defines roles for the Centers for Disease Control and Prevention (CDC), Center for Medicare and Medicaid Services (CMS), and FDA in supporting laboratory testing.7

Overview of SARS-CoV-2 test types and performance measures

In addition to understanding the regulatory matters surrounding SARS-CoV-2 testing, a basic understanding of SARS-CoV-2 test types and performance parameters is important for pharmacists who may be involved in test administration, distribution, and patient counseling. The 3 test types currently available include molecular tests, antigen tests, and serology tests.26

Molecular diagnostic tests amplify and detect pathogen-specific genetic targets, detecting target SARS-CoV-2 genetic material in the

Search strategies

FDA website documents and linked resources pertaining to COVID-19 tests, EUAs, and medical devices were consulted. Websites of the 9 COVID-19 home tests with EUAs were comprehensively reviewed. PubMed, Google Scholar, medRxiv, and bioRxiv literature searches were most recently performed in May 2021 for home tests issued EUAs. Database search details can be found in Appendix 1.

Inclusion criteria

To detect literature about the SARS-CoV-2 home tests with current EUAs, all PubMed, Google Scholar, medRxiv, and bioRxiv

Results

Searches of PubMed, Google Scholar, medRxiv, and bioRxiv yielded 15 unique studies after de-duplication.36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50 Studies identified can be found in Appendix 2. Fourteen of the studies examined the BinaxNOW platform, and 1 examined the Cue COVID-19 Test. Two studies met inclusion criteria.41,49 Seven studies were identified in the manufacturers’ EUA labeling.51, 52, 53, 54, 55, 56, 57, 58, 59 The 3 at-home BinaxNOW platforms all used the same

Discussion

Perfection is defined as “an unsurpassable degree of accuracy or excellence.”61 In medicine and science, we are trained to seek perfection in our instruments, analytical approach, and solutions. Unfortunately, we can become obsessed with striving for perfection and lose sight of our true goals. During World War II, Sir Robert Alexander Watson-Watt, developer of the early warning radar system used in Britain, was a believer in the “cult of the imperfect.”62 He was often quoted as saying, “Give

Conclusion

SARS-CoV-2 tests authorized for home use are not perfect; however, they represent a valuable resource in our effort to halt the current pandemic. The SARS-CoV-2 home tests examined in this review demonstrated satisfactory performance in comparison with laboratory RT-PCR tests. Owing to their simplicity, speed, and cost, they can help patients make informed decisions about the need to seek care and the infection risk they pose to others (Table 4).

Casey M. Kepczynski, BS, PharmD, CVS Pharmacy Intern, College of Pharmacy, Ferris State University, Big Rapids, MI

References (64)

  • Coronavirus (COVID-19) update: FDA authorizes first COVID-19 test for self-testing at home

  • Clinical laboratory improvement amendments (CLIA)

  • How to apply for a CLIA certificate, including international laboratories

  • COVID-19: calls for clinical laboratory partners

  • L.W. Ginter et al.

    Point-of-care testing. Pharmacy Times

  • Interim guidelines for collecting and handling of clinical specimens for COVID-19 testing

  • CLIA categorizations

  • Clinical laboratory improvement amendments application for certification

  • Klepser NS, Klepser DG, Adams JL, Adams AJ, Klepser ME. Impact of COVID-19 on prevalence of community pharmacies as...

  • CLIA waiver by application

  • Emergency use authorization of medical products and related authorities

  • R. Kadlec

    Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19

    Fed Regist

    (2020)

  • In vitro diagnostics EUAs

  • Office of the Assistant Secretary for Preparedness and Response. Public health emergency: Public Readiness and Emergency Preparedness Act

  • Guidance for licensed pharmacists, COVID-19 testing, and immunity under the PREP Act

  • Office of the Assistant Secretary for Preparedness and Response. Guidance for licensed pharmacists and pharmacy interns regarding COVID-19 vaccines and immunity under the PREP Act

  • Guidance for PREP Act coverage for qualified pharmacy technicians and state-authorized pharmacy interns for childhood vaccines, COVID-19 vaccines, and COVID-19 testing

  • PREP Act authorization for pharmacies distributing and administering certain covered countermeasures

  • Third amendment to declaration under the PREP act for medical countermeasures against COVID–19

  • FDA combating COVID-19 with medical devices

  • E. Altman et al.

    On the true number of COVID-19 infections: effect of sensitivity, specificity and number of tests on prevalence ratio estimation

    Int J Environ Res Public Health

    (2020)
  • R. Trevethan

    Sensitivity, specificity, and predictive values: foundations, pliabilities, and pitfalls in research and practice

    Front Public Health

    (2017)

    • Cited by (0)

    Casey M. Kepczynski, BS, PharmD, CVS Pharmacy Intern, College of Pharmacy, Ferris State University, Big Rapids, MI

    Jaelin A. Genigeski, PharmD, Meijer Pharmacy Intern, College of Pharmacy, Ferris State University, Big Rapids, MI

    Renee R. Koski, PharmD, CACP, Professor of Pharmacy Practice, College of Pharmacy, Ferris State University, Big Rapids, MI

    Allison C. Bernknopf, PharmD, MSMI, BCPS, Professor of Pharmacy Practice, College of Pharmacy, Ferris State University, Big Rapids, MI

    Alison M. Konieczny, MS, Health Sciences Librarian, College of Pharmacy, Ferris State University, Big Rapids, MI

    Michael E. Klepser, PharmD, FCCP, Professor of Pharmacy Practice, College of Pharmacy, Ferris State University, Big Rapids, MI

    Disclosure: The authors declare no relevant conflicts of interest or financial relationships.

    ORCID

    Alison M. Konieczny: https://orcid.org/0000-0002-8892-1044.

    Michael E. Klepser: https://orcid.org/0000-0001-9025-9099.

    View full text
    © 2021 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.