1887
  1. Home
  2. Eurosurveillance
  3. Volume 25, Issue 23, 11/Jun/2020
  4. Article
Rapid communication Open Access
Like 0
Download

Abstract

We reviewed the diagnostic accuracy of SARS-CoV-2 serological tests. Random-effects models yielded a summary sensitivity of 82% for IgM, and 85% for IgG and total antibodies. For specificity, the pooled estimate were 98% for IgM and 99% for IgG and total antibodies. In populations with ≤ 5% of seroconverted individuals, unless the assays have perfect (i.e. 100%) specificity, the positive predictive value would be ≤ 88%. Serological tests should be used for prevalence surveys only in hard-hit areas.

© Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
Loading

Article metrics loading...

/content/10.2807/1560-7917.ES.2020.25.23.2000980
2020-06-11
2024-11-15
http://instance.metastore.ingenta.com/content/10.2807/1560-7917.ES.2020.25.23.2000980
Loading
Loading full text...

Full text loading...

/deliver/fulltext/eurosurveillance/25/23/eurosurv-25-23-2.html?itemId=/content/10.2807/1560-7917.ES.2020.25.23.2000980&mimeType=html&fmt=ahah

References

  1. Day M. Covid-19: identifying and isolating asymptomatic people helped eliminate virus in Italian village. BMJ. 2020;368:m1165.  https://doi.org/10.1136/bmj.m1165  PMID: 32205334 
  2. World Health Organization (WHO). Q&A: Similarities and differences – COVID-19 and influenza. Geneva: WHO. [Accessed 23 Apr 2020]. Available from: https://www.who.int/news-room/q-a-detail/q-a-similarities-and-differences-covid-19-and-influenza
  3. Glas AS, Lijmer JG, Prins MH, Bonsel GJ, Bossuyt PM. The diagnostic odds ratio: a single indicator of test performance. J Clin Epidemiol. 2003;56(11):1129-35.  https://doi.org/10.1016/S0895-4356(03)00177-X  PMID: 14615004 
  4. Lou B, Li T, Zheng S, Su Y, Li Z, Liu W, et al. Serology characteristics of SARS-CoV-2 infection since the exposure and post symptoms onset. medRxiv. 2020;2020.03.23.20041707; (Preprint).
  5. Lin D, Liu L, Zhang M, Hu Y, Yang Q, Guo J, et al. Evaluations of serological test in the diagnosis of 2019 novel coronavirus (SARS-CoV-2) infections during the COVID-19 outbreak. medRxiv. 2020;2020.03.27.20045153; (Preprint).
  6. Liu W, Liu L, Kou G, Zheng Y, Ding Y, Ni W, et al. Evaluation of Nucleocapsid and Spike Protein-Based Enzyme-Linked Immunosorbent Assays for Detecting Antibodies against SARS-CoV-2. J Clin Microbiol. 2020;58(6):e00461-20.  https://doi.org/10.1128/JCM.00461-20  PMID: 32229605 
  7. Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Infect Dis. 2020;ciaa344.  https://doi.org/10.1093/cid/ciaa344  PMID: 32221519 
  8. Creative Diagnostics (CD). SARS-CoV-2 IgG ELISA Kit (DEIASL019). Product information. New York: CD. [Accessed 18 Apr 2020]. Available from: http://img2.creative-diagnostics.com/pdf/DEIASL019.pdf
  9. Epitope Diagnostics Inc. (EDI). Novel Coronavirus COVID-19 IgG ELISA Kit. Product information. San Diego: EDI. [Accessed 18 Apr 2020]. Available from: https://static1.squarespace.com/static/52545951e4b021818110f9cf/t/5e83673f1f0a06307706ad70/1585669964035/KT-1032+IVD+CE+V7_.pdf
  10. Lassaunière R, Frische A, Harboe ZB, Nielsen ACY, Fomsgaard A, Krogfelt KA, et al. Evaluation of nine commercial SARS-CoV-2 immunoassays. medRxiv. 2020;2020.04.09.20056325; (Preprint).
  11. Immunodiagnostic Products VITROS. Anti-SARS-Cov-2 Total Reagent Pack. Instructions for use. [Accessed 18 Apr 2020]. Rochester: Ortho-Clinical Diagnostics, Inc. Available from: https://www.fda.gov/media/136967/download
  12. Adams ER, Ainsworth M, Anand R, Andersson MI, Auckland K, Baillie JK, et al. Evaluation of antibody testing for SARS-Cov-2 using ELISA and lateral flow immunoassays. medRxiv. 2020;2020.04.15.20066407; (Preprint).
  13. World Health Organization (WHO). Coronavirus disease (COVID-2019) press briefing 20 April 2020. Geneva: WHO, 20 Apr 2020. [Accessed 22 Apr 2020]. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/media-resources/press-briefings#
  14. World Health Organization (WHO). Coronavirus disease (COVID-2019) press briefing 17 April 2020. Geneva: WHO, 17 Apr 2020. [Accessed 23 Apr 2020]. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/media-resources/press-briefings#
  15. World Health Organization (WHO). “Immunity passports” in the context of COVID-19. Geneva: WHO, 17 Apr 2020. [Accessed 24 Apr 2020]. Available from: https://bgr.com/2020/04/18/coronavirus-treatment-immunity-test-wont-ensure-protection-who-says/
Meta-analysis of diagnostic performance of serological tests for SARS-CoV-2 antibodies up to 25 April 2020 and public health implications
<p class="citation"> <span>Citation style for this article:</span> <span class="meta-value authors"> <a href="/search?value1=Saverio+Caini&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Caini Saverio</a>, <a href="/search?value1=Federica+Bellerba&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Bellerba Federica</a>, <a href="/search?value1=Federica+Corso&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Corso Federica</a>, <a href="/search?value1=Ang%C3%A9lica+D%C3%ADaz-Basabe&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Díaz-Basabe Angélica</a>, <a href="/search?value1=Gioacchino+Natoli&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Natoli Gioacchino</a>, <a href="/search?value1=John+Paget&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Paget John</a>, <a href="/search?value1=Federica+Facciotti&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Facciotti Federica</a>, <a href="/search?value1=Simone+Pietro+De+Angelis&option1=author&noRedirect=true" class="nonDisambigAuthorLink">De Angelis Simone Pietro</a>, <a href="/search?value1=Sara+Raimondi&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Raimondi Sara</a>, <a href="/search?value1=Domenico+Palli&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Palli Domenico</a>, <a href="/search?value1=Luca+Mazzarella&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Mazzarella Luca</a>, <a href="/search?value1=Pier+Giuseppe+Pelicci&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Pelicci Pier Giuseppe</a>, <a href="/search?value1=Paolo+Vineis&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Vineis Paolo</a>, <a href="/search?value1=Sara+Gandini&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Gandini Sara</a></span>. Meta-analysis of diagnostic performance of serological tests for SARS-CoV-2 antibodies up to 25 April 2020 and public health implications. <a href="/content/ecdc">Euro Surveill.</a> 2020;25(23):pii=2000980. <a href="https://doi.org/10.2807/1560-7917.ES.2020.25.23.2000980" title="doi link" target="_blank">https://doi.org/10.2807/1560-7917.ES.2020.25.23.2000980</a> <span class="ES_Article_citation"> <span class="generated">Received</span>: 22 May 2020;&nbsp;&nbsp; <span class="generated">Accepted</span>: 11 Jun 2020 </span> </p>
/content/10.2807/1560-7917.ES.2020.25.23.2000980
/content/10.2807/1560-7917.ES.2020.25.23.2000980
Loading

Data & Media loading...

Supplementary data

Submit comment
Close
Comment moderation successfully completed
This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error