A Trans-Governmental Collaboration to Independently Evaluate SARS-CoV-2 Serology Assays-Reference-Cited by-同舟云学术

A Trans-Governmental Collaboration to Independently Evaluate SARS-CoV-2 Serology Assays

Published:2022-02-23 Issue:1 Volume:10 Page:
ISSN:2165-0497
Container-title:Microbiology Spectrum
language:en
Short-container-title:Microbiol Spectr

Author:

Pinto Ligia A.¹^ORCID,Shawar Ribhi M.²,O’Leary Brendan²,Kemp Troy J.¹,Cherry James³,Thornburg Natalie⁴,Miller Cheryl N.¹,Gallagher Pamela S.²,Stenzel Timothy²,Schuck Brittany²,Owen S. Michele⁴,Kondratovich Marina²,Satheshkumar Panayampalli S.⁴,Schuh Amy⁴,Lester Sandra⁴,Cassetti M. Cristina⁵,Sharpless Norman E.³,Gitterman Steven²,Lowy Douglas R.³

Affiliation:

1. Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA

2. U.S. Food and Drug Administration, Silver Spring, Maryland, USA

3. National Cancer Institute, Bethesda, Maryland, USA

4. Centers for Disease Control and Prevention, Atlanta, Georgia, USA

5. National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA

Abstract

The SARS-CoV-2 pandemic created a crucial need for accurate serology assays to evaluate seroprevalence, contact tracing, and antiviral immune responses. The initial flood of serology assays entering the market with inadequate performance emphasized the need for independent evaluation of commercial SARS-CoV-2 antibody assays using performance evaluation panels to determine suitability for use under emergency use authorization (EUA).

Funder

HHS | NIH | National Cancer Institute

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Cell Biology,Microbiology (medical),Genetics,General Immunology and Microbiology,Ecology,Physiology

Link

https://journals.asm.org/doi/pdf/10.1128/spectrum.01564-21

Reference19 articles.

1. WHO. 2020. WHO COVID-19 Dashboard. Geneva: World Health Organization. https://covid19.who.int/.

2. HHS. 2020. Determination of Public Health Emergency on National Archives. https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency.

3. FDA. 2020. Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised.

4. The FDA’s Experience with Covid-19 Antibody Tests

5. FDA. 2020. Important Information on the Use of Serological (Antibody) Tests for COVID-19 - Letter to Health Care Providers. https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests-covid-19-letter-health-care-providers.

Cited by 9 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. The importance of using WHO International Standards to harmonise SARS-CoV-2 serological assays;The Lancet Microbe;2024-03

2. Comprehensive, comparative evaluation of 25 automated SARS-CoV-2 serology assays;Microbiology Spectrum;2024-01-11

3. From HPV to COVID-19 and beyond: leveraging the power of serology and standards;The Lancet Microbe;2023-12

4. Immunological tests: Essential and supportive tools in the fight against COVID-19;TrAC Trends in Analytical Chemistry;2023-11

5. Assay Harmonization Study To Measure Immune Response to SARS-CoV-2 Infection and Vaccines: a Serology Methods Study;Microbiology Spectrum;2023-06-15