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
. 2020 Jun 16;9(6):1871.
doi: 10.3390/jcm9061871.

Performance Assessment of SARS-CoV-2 PCR Assays Developed by WHO Referral Laboratories

Sibyle Etievant  1   2 , Antonin Bal  1   2   3   4 , Vanessa Escuret  1   2   4 , Karen Brengel-Pesce  3 , Maude Bouscambert  1   2 , Valérie Cheynet  3 , Laurence Generenaz  3 , Guy Oriol  3 , Gregory Destras  1 , Geneviève Billaud  1 , Laurence Josset  1   4 , Emilie Frobert  1   4 , Florence Morfin  1   4 , Alexandre Gaymard  1   2   4
Affiliations

Performance Assessment of SARS-CoV-2 PCR Assays Developed by WHO Referral Laboratories

Sibyle Etievant et al. J Clin Med. .

Abstract

A reliable diagnostic assay is crucial to early detect new COVID-19 cases and limit severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission. Since the onset of the COVID-19 pandemic, the World Health Organization has published several diagnostic molecular approaches developed by referral laboratories, including Charité (Germany), HKU (Hong Kong), China CDC (China), US CDC (United States), and Institut Pasteur, Paris (France). We aimed to compare the sensitivity and specificity of these different RT-PCR assays using SARS-CoV-2 cell culture supernatants and clinical respiratory samples. Overall, the different RT-PCR assays performed well for SARS-CoV-2 detection and were all specific except the N Charité (Germany), and N2 US CDC (United States) assays. RdRp Institut Pasteur (IP2, IP4), N China CDC, and N1 US CDC were found to be the most sensitive assays. The data presented herein are of prime importance to facilitate the equipment choice of diagnostic laboratories, as well as for the development of marketed tests.

Keywords: COVID-19; RT-PCR; SARS-CoV-2; diagnostics; sensitivity.

PubMed Disclaimer

Conflict of interest statement

S.E., V.E., M.B., G.D., G.B., L.J., E.F., F.M., and A.G. declare no conflict of interest. A.B has received a research grant from bioMérieux. K.B.-P., V.C., L.G., and G.O. are employees at bioMérieux. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

Figures

Figure 1
Figure 1
Mean Ct values and standard deviations obtained using five PCR-based methods for SARS-CoV-2 detection. Serial dilutions of SARS-CoV-2 cell culture supernatants were used and are represented by a single color (10−5 blue, 10−6 red, 10−7 pink, 10−8 green). A point in the ND (non-detected) column (Ct value axis) indicates a negative result for one replicate.
Figure 2
Figure 2
Ct values for 16 positive clinical samples using the three most sensitive assays. N China CDC is represented by green circles, N1 US CDC by purple squares, and RdRp IP2 Institut Pasteur, Paris, by orange triangles.
See this image and copyright information in PMC

References

    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;5:536–544. doi: 10.1038/s41564-020-0695-z. - DOI - PMC - PubMed
    1. World Health Organization WHO Announces COVID-19 Outbreak a Pandemic. [(accessed on 6 April 2020)]; Available online: http://www.euro.who.int/en/health-topics/health-emergencies/coronavirus-....
    1. World Health Organization Coronavirus Disease 2019 (COVID-19)—Situation Report—127. [(accessed on 26 May 2020)]; Available online: https://www.who.int/docs/default-source/coronaviruse/situation-reports/2....
    1. Holmes E.C. Novel 2019 Coronavirus Genome. [(accessed on 24 March 2020)]; Available online: http://virological.org/t/novel-2019-coronavirus-genome/319.
    1. Corman V., Landt O., Kaiser M., Molenkamp R., Meijer A., Chu D., Bleicker T., Brünink S., Schneider J., Schmidt M.L., et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Eurosurveillance. 2020;25:2000045. doi: 10.2807/1560-7917.ES.2020.25.3.2000045. - DOI - PMC - PubMed