Importance of anti-SARS-CoV-2 assay antigenic composition as revealed by the results of the Belgian external quality assessment (EQA) scheme

Alena Moerman; Kris Vernelen; Bernard China; Arnaud Capron; Dorien Van Den Bossche; Joachim Mariën; Kevin K Ariën; Jos Van Acker; Marie-Luce Delforge; Marijke Reynders; An Boel; Melissa Depypere; Natasja Van Gasse; Sara Vijgen; Jonathan Brauner; Barbara Dujardin; Elizaveta Padalko

doi:10.1016/j.diagmicrobio.2021.115561

Importance of anti-SARS-CoV-2 assay antigenic composition as revealed by the results of the Belgian external quality assessment (EQA) scheme

Alena Moerman, Kris Vernelen, Bernard China, Arnaud Capron, Dorien Van Den Bossche, Joachim Mariën, Kevin K Ariën, Jos Van Acker, Marie-Luce Delforge, Marijke Reynders, An Boel, Melissa Depypere, Natasja Van Gasse, Sara Vijgen, Jonathan Brauner, Barbara Dujardin, Elizaveta Padalko

Research output: Contribution to journal › A1: Web of Science-article › peer-review

Abstract

We report on sample IS/17575 since it generated highly divergent results in the Belgian SARS-CoV-2 serology external quality assessment scheme. Sample IS/17575 was serum originating from a 30 years old male patient. 124 diagnostic laboratories analysed this sample. A total of 168 results was returned (including 5 doubles). Overall, 38 were positive. All tests against S1 were positive except the Euroimmun IgG ELISA and the Ortho clinical Diagnostics VITROS IgG CLIA. All tests against S1/S2 (Liaison, Diasorin) resulted in a signal above cutoff. Assays against RBD, mostly generate a negative result. An exception are the Wantai SARS-CoV-2 ELISA's. All tests targeting N protein were negative. The survey shows, when >6 months post-infection, assays targeting at least S1, and preferably S1 combined with S2, are the most sensitive. This finding accentuates the necessity of external quality assessment schedules and importance of antigenic composition of serologic SARS-CoV-2 assays.

Original language	English
Article number	115561
Journal	Diagnostic Microbiology and Infectious Disease
Volume	102
Issue number	2
Number of pages	6
ISSN	0732-8893
DOIs	https://doi.org/10.1016/j.diagmicrobio.2021.115561
Publication status	Published - 2022

Keywords

Adult
Antibodies, Viral/immunology
Antigens, Viral/immunology
Belgium
COVID-19/diagnosis
COVID-19 Serological Testing/methods
Coronavirus Nucleocapsid Proteins/immunology
Diagnostic Tests, Routine
Enzyme-Linked Immunosorbent Assay
Humans
Immunoglobulin A/immunology
Immunoglobulin G/immunology
Immunoglobulin M/immunology
Male
Phosphoproteins/immunology
SARS-CoV-2/immunology
Sensitivity and Specificity
Spike Glycoprotein, Coronavirus/immunology

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10.1016/j.diagmicrobio.2021.115561

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Moerman, A., Vernelen, K., China, B., Capron, A., Van Den Bossche, D., Mariën, J., Ariën, K. K., Van Acker, J., Delforge, M.-L., Reynders, M., Boel, A., Depypere, M., Van Gasse, N., Vijgen, S., Brauner, J., Dujardin, B., & Padalko, E. (2022). Importance of anti-SARS-CoV-2 assay antigenic composition as revealed by the results of the Belgian external quality assessment (EQA) scheme. Diagnostic Microbiology and Infectious Disease, 102(2), Article 115561. https://doi.org/10.1016/j.diagmicrobio.2021.115561

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title = "Importance of anti-SARS-CoV-2 assay antigenic composition as revealed by the results of the Belgian external quality assessment (EQA) scheme",

abstract = "We report on sample IS/17575 since it generated highly divergent results in the Belgian SARS-CoV-2 serology external quality assessment scheme. Sample IS/17575 was serum originating from a 30 years old male patient. 124 diagnostic laboratories analysed this sample. A total of 168 results was returned (including 5 doubles). Overall, 38 were positive. All tests against S1 were positive except the Euroimmun IgG ELISA and the Ortho clinical Diagnostics VITROS IgG CLIA. All tests against S1/S2 (Liaison, Diasorin) resulted in a signal above cutoff. Assays against RBD, mostly generate a negative result. An exception are the Wantai SARS-CoV-2 ELISA's. All tests targeting N protein were negative. The survey shows, when >6 months post-infection, assays targeting at least S1, and preferably S1 combined with S2, are the most sensitive. This finding accentuates the necessity of external quality assessment schedules and importance of antigenic composition of serologic SARS-CoV-2 assays.",

keywords = "Adult, Antibodies, Viral/immunology, Antigens, Viral/immunology, Belgium, COVID-19/diagnosis, COVID-19 Serological Testing/methods, Coronavirus Nucleocapsid Proteins/immunology, Diagnostic Tests, Routine, Enzyme-Linked Immunosorbent Assay, Humans, Immunoglobulin A/immunology, Immunoglobulin G/immunology, Immunoglobulin M/immunology, Male, Phosphoproteins/immunology, SARS-CoV-2/immunology, Sensitivity and Specificity, Spike Glycoprotein, Coronavirus/immunology",

author = "Alena Moerman and Kris Vernelen and Bernard China and Arnaud Capron and {Van Den Bossche}, Dorien and Joachim Mari{\"e}n and Ari{\"e}n, {Kevin K} and {Van Acker}, Jos and Marie-Luce Delforge and Marijke Reynders and An Boel and Melissa Depypere and {Van Gasse}, Natasja and Sara Vijgen and Jonathan Brauner and Barbara Dujardin and Elizaveta Padalko",

year = "2022",

doi = "10.1016/j.diagmicrobio.2021.115561",

language = "English",

volume = "102",

journal = "Diagnostic Microbiology and Infectious Disease",

issn = "0732-8893",

publisher = "Elsevier",

number = "2",

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Moerman, A, Vernelen, K, China, B, Capron, A, Van Den Bossche, D , Mariën, J , Ariën, KK, Van Acker, J, Delforge, M-L, Reynders, M, Boel, A, Depypere, M, Van Gasse, N, Vijgen, S, Brauner, J, Dujardin, B & Padalko, E 2022, 'Importance of anti-SARS-CoV-2 assay antigenic composition as revealed by the results of the Belgian external quality assessment (EQA) scheme', Diagnostic Microbiology and Infectious Disease, vol. 102, no. 2, 115561. https://doi.org/10.1016/j.diagmicrobio.2021.115561

TY - JOUR

T1 - Importance of anti-SARS-CoV-2 assay antigenic composition as revealed by the results of the Belgian external quality assessment (EQA) scheme

AU - Moerman, Alena

AU - Vernelen, Kris

AU - China, Bernard

AU - Capron, Arnaud

AU - Van Den Bossche, Dorien

AU - Mariën, Joachim

AU - Ariën, Kevin K

AU - Van Acker, Jos

AU - Delforge, Marie-Luce

AU - Reynders, Marijke

AU - Boel, An

AU - Depypere, Melissa

AU - Van Gasse, Natasja

AU - Vijgen, Sara

AU - Brauner, Jonathan

AU - Dujardin, Barbara

AU - Padalko, Elizaveta

PY - 2022

Y1 - 2022

N2 - We report on sample IS/17575 since it generated highly divergent results in the Belgian SARS-CoV-2 serology external quality assessment scheme. Sample IS/17575 was serum originating from a 30 years old male patient. 124 diagnostic laboratories analysed this sample. A total of 168 results was returned (including 5 doubles). Overall, 38 were positive. All tests against S1 were positive except the Euroimmun IgG ELISA and the Ortho clinical Diagnostics VITROS IgG CLIA. All tests against S1/S2 (Liaison, Diasorin) resulted in a signal above cutoff. Assays against RBD, mostly generate a negative result. An exception are the Wantai SARS-CoV-2 ELISA's. All tests targeting N protein were negative. The survey shows, when >6 months post-infection, assays targeting at least S1, and preferably S1 combined with S2, are the most sensitive. This finding accentuates the necessity of external quality assessment schedules and importance of antigenic composition of serologic SARS-CoV-2 assays.

AB - We report on sample IS/17575 since it generated highly divergent results in the Belgian SARS-CoV-2 serology external quality assessment scheme. Sample IS/17575 was serum originating from a 30 years old male patient. 124 diagnostic laboratories analysed this sample. A total of 168 results was returned (including 5 doubles). Overall, 38 were positive. All tests against S1 were positive except the Euroimmun IgG ELISA and the Ortho clinical Diagnostics VITROS IgG CLIA. All tests against S1/S2 (Liaison, Diasorin) resulted in a signal above cutoff. Assays against RBD, mostly generate a negative result. An exception are the Wantai SARS-CoV-2 ELISA's. All tests targeting N protein were negative. The survey shows, when >6 months post-infection, assays targeting at least S1, and preferably S1 combined with S2, are the most sensitive. This finding accentuates the necessity of external quality assessment schedules and importance of antigenic composition of serologic SARS-CoV-2 assays.

KW - Adult

KW - Antibodies, Viral/immunology

KW - Antigens, Viral/immunology

KW - Belgium

KW - COVID-19/diagnosis

KW - COVID-19 Serological Testing/methods

KW - Coronavirus Nucleocapsid Proteins/immunology

KW - Diagnostic Tests, Routine

KW - Enzyme-Linked Immunosorbent Assay

KW - Humans

KW - Immunoglobulin A/immunology

KW - Immunoglobulin G/immunology

KW - Immunoglobulin M/immunology

KW - Male

KW - Phosphoproteins/immunology

KW - SARS-CoV-2/immunology

KW - Sensitivity and Specificity

KW - Spike Glycoprotein, Coronavirus/immunology

U2 - 10.1016/j.diagmicrobio.2021.115561

DO - 10.1016/j.diagmicrobio.2021.115561

M3 - A1: Web of Science-article

C2 - 34773801

SN - 0732-8893

VL - 102

JO - Diagnostic Microbiology and Infectious Disease

JF - Diagnostic Microbiology and Infectious Disease

IS - 2

M1 - 115561

ER -

Importance of anti-SARS-CoV-2 assay antigenic composition as revealed by the results of the Belgian external quality assessment (EQA) scheme

Abstract

Keywords

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