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
Comparative Study
. 2020 Aug:129:104529.
doi: 10.1016/j.jcv.2020.104529. Epub 2020 Jun 29.

Comparison of commercial lateral flow immunoassays and ELISA for SARS-CoV-2 antibody detection

Maria Martínez Serrano  1 , David Navalpotro Rodríguez  2 , Nuria Tormo Palop  2 , Roberto Olmos Arenas  2 , Marta Moreno Córdoba  2 , Mª Dolores Ocete Mochón  2 , Concepción Gimeno Cardona  3
Affiliations
Comparative Study

Comparison of commercial lateral flow immunoassays and ELISA for SARS-CoV-2 antibody detection

Maria Martínez Serrano et al. J Clin Virol. 2020 Aug.

Abstract

Background: COVID-19 pandemic has spread worldwide since December 2019. Serological tests for SARS-CoV-2 antibody testing are needed for detection of current or past infections. A wide range of commercial tests is available. However, most of them need to be validated.

Study design: The aim was to compare a commercial IgG and IgA ELISA (Euroimmun) with three lateral flow immunoassays (LFI): Hangzhou Alltest Biotech, Wuhan UNscience Biotechnology and Guangzhou Wondfo Biotech. Specificity was calculated with 62 available serum samples from 2018/19. The study included 152 sera from patients of which 109 were RT-PCR positive. Sensitivities for ELISA anti SARS-CoV-2 IgG and IgA were 81.5 % and 93.1 % and specificities 100 % and 80.6 %, respectively. LFI showed variable performances, overall results being better for Guangzhou Wondfo Biotech.

Conclusions: Commercial serological tests are useful for detection of antibodies in patients with COVID-19. ELISA presented better results than LFI. The results allowed to incorporate the most sensitive LFI to the daily workflow, combining with ELISA. Careful validation is encouraged before clinical laboratories start using these tests.

Keywords: Antibody detection; COVID-19; Diagnosis; SARS-CoV-2; Sensitivity; Specificity.

PubMed Disclaimer

Conflict of interest statement

Declaration of Competing Interest None declared.

Figures

Fig. 1
Fig. 1
ELISA IgG ratios in different WHO classification COVID-19 groups of patients (over 10 days after onset of symptoms) and NC-COVID-19.
See this image and copyright information in PMC

References

    1. Zhou P., Lou Yang X., Wang X.G., Hu B., Zhang L., Zhang W., Si H.R., Zhu Y., Li B., Huang C.L., Chen H.D., Chen J., Luo Y., Guo H., Di Jiang R., Liu M.Q., Chen Y., Shen X.R., Wang X., Zheng X.S., Zhao K., Chen Q.J., Deng F., Liu L.L., Yan B., Zhan F.X., Wang Y.Y., Xiao G.F., Shi Z.L. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020;579:270–273. doi: 10.1038/s41586-020-2012-7. - DOI - PMC - PubMed
    1. Gorbalenya A.E., Baker S.C., Baric R.S., de Groot R.J., Drosten C., Gulyaeva A.A., Haagmans B.L., Lauber C., Leontovich A.M., Neuman B.W., Penzar D., Perlman S., Poon L.L.M., Samborskiy D.V., Sidorov I.A., Sola I., Ziebuhr J. 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. Director-General’s opening remarks at the media briefing on COVID-19 -. 11 March 2020.
    1. World Health Organization. Coronavirus disease (COVID-19) Situation Report-123, 2020.
    1. Corman V.M., Landt O., Kaiser M., Molenkamp R., Meijer A., Chu D.K.W., Bleicker T., Brünink S., Schneider J., Schmidt M.L., Mulders D.G.J.C., Haagmans B.L., Van Der Veer B., Van Den Brink S., Wijsman L., Goderski G., Romette J.L., Ellis J., Zambon M., Peiris M., Goossens H., Reusken C., Koopmans M.P.G., Drosten C. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Eurosurveillance. 2020;25 doi: 10.2807/1560-7917.ES.2020.25.3.2000045. - DOI - PMC - PubMed

MeSH terms