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Evaluation of two automated and three rapid lateral flow immunoassays for the detection of anti-SARS-CoV-2 antibodies.
J Clin Virol. 2020 07; 128:104413.JC

Abstract

INTRODUCTION

Several SARS-CoV-2 immunoassays have been developed recently. The purpose of this study was to assess the performance of five immunoassays for the detection of SARS-CoV-2 antibodies.

METHODS

Two quantitative automated immunoassays (Maglumi™2019-n-Cov IgG and IgM and Euroimmun Anti-SARS-CoV-2 IgG and IgA assays) and three lateral flow rapid tests were performed. This retrospective study included 200 residual sera from patients and healthy volunteers. Case serum samples (n = 128) were obtained from COVID-19 patients confirmed by RT-qPCR and CT-scan. Days since onset of symptoms was collected from their medical records. Control non-SARS-CoV-2 samples (n = 72) were obtained from anonymous stored residual serum samples.

RESULTS

Maglumi™ IgG/IgM tests showed overall less sensitivity than Euroimmun IgG/IgA test (84.4 % versus 64.3 %). Both tests showed similar specificities of IgG at 99 % and 100 %, respectively. The results from the lateral flow assays were easily interpretable with unambiguous coloured reading bands. The overall sensitivity of the three tests was similar (around 70 %) without any significant differences. The sensitivity of the three lateral flow assays and also of the serological quantitative assays increased during the second week after symptom onset and all reached similar values (91 %-94 %) after 14 days.

CONCLUSION

This study shows accurate and equivalent performance of the five serological antibody assays (ELISA, CLIA and three lateral flow tests) in detecting SARS-CoV-2 antibodies 14 days after the onset of COVID-19 symptoms. This is compatible with their application in specific clinical contexts and in determining epidemiological strategies for the COVID-19 pandemic.

Authors+Show Affiliations

Microbiology Department, Laboratoire Hospitalier Universitaire de Bruxelles - Universitair Laboratorium Brussel (LHUB-ULB), Université Libre de Bruxelles, Brussels, Belgium. Electronic address: Carlota.montesinos@LHUB-ULB.be.Department of Clinical Biochemistry, Cliniques Universitaires Saint-Luc, UCLouvain (CUSL), Avenue Hippocrate 10, 1200, Brussels, Belgium.Microbiology Department, Cliniques Universitaires Saint-Luc, UCLouvain (CUSL), Avenue Hippocrate 10, 1200, Brussels, Belgium.Microbiology Department, Laboratoire Hospitalier Universitaire de Bruxelles - Universitair Laboratorium Brussel (LHUB-ULB), Université Libre de Bruxelles, Brussels, Belgium.Microbiology Department, Laboratoire Hospitalier Universitaire de Bruxelles - Universitair Laboratorium Brussel (LHUB-ULB), Université Libre de Bruxelles, Brussels, Belgium.Microbiology Department, Cliniques Universitaires Saint-Luc, UCLouvain (CUSL), Avenue Hippocrate 10, 1200, Brussels, Belgium.Department of Clinical Biochemistry, Cliniques Universitaires Saint-Luc, UCLouvain (CUSL), Avenue Hippocrate 10, 1200, Brussels, Belgium.Innovation and Business Development Unit, Laboratoire Hospitalier Universitaire de Bruxelles - Universitair Laboratorium Brussel (LHUB-ULB), Université Libre de Bruxelles, Brussels, Belgium.Clinical Chemistry Department, Laboratoire Hospitalier Universitaire Bruxelles - Universitair Laboratorium Brussel (LHUB-ULB). Université Libre de Bruxelles, Brussels, Belgium.Clinical Biology, Laboratoire Hospitalier Universitaire de Bruxelles - Universitair Laboratorium Brussel (LHUB-ULB), Université Libre de Bruxelles, Brussels, Belgium.Microbiology Department, Cliniques Universitaires Saint-Luc, UCLouvain (CUSL), Avenue Hippocrate 10, 1200, Brussels, Belgium.

Pub Type(s)

Evaluation Study
Journal Article

Language

eng

PubMed ID

32403010

Citation

Montesinos, Isabel, et al. "Evaluation of Two Automated and Three Rapid Lateral Flow Immunoassays for the Detection of anti-SARS-CoV-2 Antibodies." Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, vol. 128, 2020, p. 104413.
Montesinos I, Gruson D, Kabamba B, et al. Evaluation of two automated and three rapid lateral flow immunoassays for the detection of anti-SARS-CoV-2 antibodies. J Clin Virol. 2020;128:104413.
Montesinos, I., Gruson, D., Kabamba, B., Dahma, H., Van den Wijngaert, S., Reza, S., Carbone, V., Vandenberg, O., Gulbis, B., Wolff, F., & Rodriguez-Villalobos, H. (2020). Evaluation of two automated and three rapid lateral flow immunoassays for the detection of anti-SARS-CoV-2 antibodies. Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, 128, 104413. https://doi.org/10.1016/j.jcv.2020.104413
Montesinos I, et al. Evaluation of Two Automated and Three Rapid Lateral Flow Immunoassays for the Detection of anti-SARS-CoV-2 Antibodies. J Clin Virol. 2020;128:104413. PubMed PMID: 32403010.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of two automated and three rapid lateral flow immunoassays for the detection of anti-SARS-CoV-2 antibodies. AU - Montesinos,Isabel, AU - Gruson,Damien, AU - Kabamba,Benoit, AU - Dahma,Hafid, AU - Van den Wijngaert,Sigi, AU - Reza,Soleimani, AU - Carbone,Vincenzo, AU - Vandenberg,Olivier, AU - Gulbis,Beatrice, AU - Wolff,Fleur, AU - Rodriguez-Villalobos,Hector, Y1 - 2020/05/05/ PY - 2020/04/24/received PY - 2020/04/27/revised PY - 2020/04/30/accepted PY - 2020/5/14/pubmed PY - 2020/7/7/medline PY - 2020/5/14/entrez KW - CLIA KW - COVID-19 KW - ELISA KW - Immunoassays KW - Lateral flow assays KW - SARS-CoV-2 SP - 104413 EP - 104413 JF - Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology JO - J Clin Virol VL - 128 N2 - INTRODUCTION: Several SARS-CoV-2 immunoassays have been developed recently. The purpose of this study was to assess the performance of five immunoassays for the detection of SARS-CoV-2 antibodies. METHODS: Two quantitative automated immunoassays (Maglumi™2019-n-Cov IgG and IgM and Euroimmun Anti-SARS-CoV-2 IgG and IgA assays) and three lateral flow rapid tests were performed. This retrospective study included 200 residual sera from patients and healthy volunteers. Case serum samples (n = 128) were obtained from COVID-19 patients confirmed by RT-qPCR and CT-scan. Days since onset of symptoms was collected from their medical records. Control non-SARS-CoV-2 samples (n = 72) were obtained from anonymous stored residual serum samples. RESULTS: Maglumi™ IgG/IgM tests showed overall less sensitivity than Euroimmun IgG/IgA test (84.4 % versus 64.3 %). Both tests showed similar specificities of IgG at 99 % and 100 %, respectively. The results from the lateral flow assays were easily interpretable with unambiguous coloured reading bands. The overall sensitivity of the three tests was similar (around 70 %) without any significant differences. The sensitivity of the three lateral flow assays and also of the serological quantitative assays increased during the second week after symptom onset and all reached similar values (91 %-94 %) after 14 days. CONCLUSION: This study shows accurate and equivalent performance of the five serological antibody assays (ELISA, CLIA and three lateral flow tests) in detecting SARS-CoV-2 antibodies 14 days after the onset of COVID-19 symptoms. This is compatible with their application in specific clinical contexts and in determining epidemiological strategies for the COVID-19 pandemic. SN - 1873-5967 UR - https://www.unboundmedicine.com/medline/citation/32403010/Evaluation_of_two_automated_and_three_rapid_lateral_flow_immunoassays_for_the_detection_of_anti_SARS_CoV_2_antibodies_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1386-6532(20)30155-4 DB - PRIME DP - Unbound Medicine ER -