Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Editorial
. 2021 Aug;13(15):1169-1171.
doi: 10.4155/bio-2021-0103. Epub 2021 Aug 10.

COVID-19's impact on bioanalytical labs

Amy Lavelle  1 , Janine Micheli  1
Affiliations
Editorial

COVID-19's impact on bioanalytical labs

Amy Lavelle et al. Bioanalysis. 2021 Aug.

Abstract

Tweetable abstract One year later, the impact of the COVID-19 pandemic on business practices, supply chains, timelines and analytical needs for COVID-19 clinical trials have been felt across the bioanalytical community, as therapeutics may now require SARS-CoV-2 antigen and serological testing.

Keywords: COVID-19; NAAT; SARS-CoV-2 antigen; bioanalysis; clinical trials; serology.

PubMed Disclaimer

Conflict of interest statement

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

References

    1. Globaldata PLC. Coronavirus disease 2019 pharma executive briefing. 59 (2021). https://pharma.globaldata.com/Analysis/TableOfContents/Coronavirus-Disea...
    1. Younes N, Al-SAdeq DW, Al-Jighefee Het al.Challenges in laboratory diagnosis of the novel coronavirus SARS-CoV-2. Viruses 12(6), 582 (2020). - PMC - PubMed
    1. US FDA. In Vitro Diagnostics EUAs – molecular diagnostic tests for SARS-CoV-2. http://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-eme...
    1. US FDA. In Vitro Diagnostics EUAs – serology and other adaptive immune response tests for SARS-CoV-2. http://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-eme...
    1. US FDA. COVID-19: developing drugs and biological products for treatment or prevention. FDA Guid. Ind. (2021). https://www.fda.gov/regulatory-information/search-fda-guidance-documents...

Publication types