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
Review
. 2022 Jun;42(2):161-191.
doi: 10.1016/j.cll.2022.02.005. Epub 2022 Mar 8.

An Overview of SARS-CoV-2 Molecular Diagnostics in Europe

Emma Davies  1 , Hamzah Z Farooq  2 , Benjamin Brown  3 , Peter Tilston  3 , Ashley McEwan  3 , Andrew Birtles  3 , Robert William O'Hara  3 , Shazaad Ahmad  3 , Nicholas Machin  3 , Louise Hesketh  3 , Malcolm Guiver  3
Affiliations
Review

An Overview of SARS-CoV-2 Molecular Diagnostics in Europe

Emma Davies et al. Clin Lab Med. 2022 Jun.

Abstract

The COVID-19 pandemic has led to the rapid development of a plethora of molecular diagnostic assays with real-time polymerase chain reaction (RT-PCR) at the forefront. In this review, we will discuss the history and utility of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) molecular diagnostics and the associated current and future regulatory process in Europe. We will assess the performance characteristics of a range of the most common SARS-CoV-2 molecular tests currently used in Europe with a focus on as rapid molecular platforms, stand-alone RT-PCR kits, the role of low-throughput and high-throughput end-to-end testing platforms, and the rapidly evolving field of SARS-CoV-2 variant of concern identification.

Keywords: CE Marking; COVID-19; Molecular diagnostics; RT-PCR; SARS-CoV-2.

PubMed Disclaimer

References

    1. ProMED-mail. Published Date : 2020-01-05 18 : 15 : 37 Subject : PRO/AH/EDR > Undiagnosed Pneumonia - China ( HU ) ( 03 ): Updates , SARS , MERS Ruled out , WHO , RFI Archive Number : 20200105 . 6872267.; 2020.
    1. Zhang Y-Z. Initial genome release of novel coronavirus. Virological. Available at: https://virological.org/t/novel-2019-coronavirus-genome/319. 2020. Accessed June 23, 2021.
    1. World Health Organization. Novel coronavirus (2019-NCoV) situation reports. Available at: https://www.who.int/docs/default-source/coronaviruse/situation-reports/2.... 2020. Accessed June 23, 2021.
    1. Coronaviridae Study Group of the International Committee on Taxonomy of Viruses The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020;5(4):536–544. - PMC - PubMed
    1. World Health Organization. Naming the coronavirus disease (COVID-19) and the virus that causes it. Available at: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technica.... 2020. Accessed June 23, 2021.

Supplementary concepts