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Comparison of 16 Serological SARS-CoV-2 Immunoassays in 16 Clinical Laboratories

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Harvard

Harritshøj, LH, Gybel-Brask, M, Afzal, S, Kamstrup, PR, Jørgensen, CS, Thomsen, MK, Hilsted, L, Friis-Hansen, L, Szecsi, PB, Pedersen, L, Nielsen, L, Hansen, CB, Garred, P, Korsholm, T-L, Mikkelsen, S, Nielsen, KO, Møller, BK, Hansen, AT, Iversen, KK, Nielsen, PB, Hasselbalch, RB, Fogh, K, Norsk, JB, Kristensen, JH, Schønning, K, Kirkby, NS, Nielsen, ACY, Landsy, LH, Loftager, M, Holm, DK, Nilsson, AC, Sækmose, SG, Grum-Schwensen, B, Aagaard, B, Jensen, TG, Nielsen, DM, Ullum, H & Dessau, RBC 2021, 'Comparison of 16 Serological SARS-CoV-2 Immunoassays in 16 Clinical Laboratories', Journal of Clinical Microbiology, bind 59, nr. 5, e02596-20. https://doi.org/10.1128/JCM.02596-20

APA

Harritshøj, L. H., Gybel-Brask, M., Afzal, S., Kamstrup, P. R., Jørgensen, C. S., Thomsen, M. K., Hilsted, L., Friis-Hansen, L., Szecsi, P. B., Pedersen, L., Nielsen, L., Hansen, C. B., Garred, P., Korsholm, T-L., Mikkelsen, S., Nielsen, K. O., Møller, B. K., Hansen, A. T., Iversen, K. K., ... Dessau, R. B. C. (2021). Comparison of 16 Serological SARS-CoV-2 Immunoassays in 16 Clinical Laboratories. Journal of Clinical Microbiology, 59(5), [e02596-20]. https://doi.org/10.1128/JCM.02596-20

CBE

Harritshøj LH, Gybel-Brask M, Afzal S, Kamstrup PR, Jørgensen CS, Thomsen MK, Hilsted L, Friis-Hansen L, Szecsi PB, Pedersen L, Nielsen L, Hansen CB, Garred P, Korsholm T-L, Mikkelsen S, Nielsen KO, Møller BK, Hansen AT, Iversen KK, Nielsen PB, Hasselbalch RB, Fogh K, Norsk JB, Kristensen JH, Schønning K, Kirkby NS, Nielsen ACY, Landsy LH, Loftager M, Holm DK, Nilsson AC, Sækmose SG, Grum-Schwensen B, Aagaard B, Jensen TG, Nielsen DM, Ullum H, Dessau RBC. 2021. Comparison of 16 Serological SARS-CoV-2 Immunoassays in 16 Clinical Laboratories. Journal of Clinical Microbiology. 59(5):Article e02596-20. https://doi.org/10.1128/JCM.02596-20

MLA

Vancouver

Author

Harritshøj, Lene H ; Gybel-Brask, Mikkel ; Afzal, Shoaib ; Kamstrup, Pia R ; Jørgensen, Charlotte S ; Thomsen, Marianne Kragh ; Hilsted, Linda ; Friis-Hansen, Lennart ; Szecsi, Pal B ; Pedersen, Lise ; Nielsen, Lene ; Hansen, Cecilie B ; Garred, Peter ; Korsholm, Trine-Line ; Mikkelsen, Susan ; Nielsen, Kirstine O ; Møller, Bjarne K ; Hansen, Anne T ; Iversen, Kasper K ; Nielsen, Pernille B ; Hasselbalch, Rasmus B ; Fogh, Kamille ; Norsk, Jakob B ; Kristensen, Jonas Henrik ; Schønning, Kristian ; Kirkby, Nikolai S ; Nielsen, Alex C Y ; Landsy, Lone H ; Loftager, Mette ; Holm, Dorte K ; Nilsson, Anna C ; Sækmose, Susanne G ; Grum-Schwensen, Birgitte ; Aagaard, Bitten ; Jensen, Thøger G ; Nielsen, Dorte M ; Ullum, Henrik ; Dessau, Ram B C. / Comparison of 16 Serological SARS-CoV-2 Immunoassays in 16 Clinical Laboratories. I: Journal of Clinical Microbiology. 2021 ; Bind 59, Nr. 5.

Bibtex

@article{ef185e02be394df2aaf1a97d2696b990,
title = "Comparison of 16 Serological SARS-CoV-2 Immunoassays in 16 Clinical Laboratories",
abstract = "Serological assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are needed to support clinical diagnosis and epidemiological investigations. Recently, assays for large-scale detection of total antibodies (Ab), immunoglobulin G (IgG), and IgM against SARS-CoV-2 antigens have been developed, but there are limited data on the diagnostic accuracy of these assays. This study was a Danish national collaboration and evaluated 15 commercial and one in-house anti-SARS-CoV-2 assays in 16 laboratories. Sensitivity was evaluated using 150 samples from individuals with asymptomatic, mild, or moderate COVID-19, nonhospitalized or hospitalized, confirmed by nucleic acid amplification tests (NAAT); samples were collected 13 to 73 days either from symptom onset or from positive NAAT (patients without symptoms). Specificity and cross-reactivity were evaluated in samples collected prior to the SARS-CoV-2 epidemic from >586 blood donors and patients with autoimmune diseases, cytomegalovirus or Epstein-Barr virus infections, and acute viral infections. A specificity of ≥99% was achieved by all total-Ab and IgG assays except one, DiaSorin Liaison XL IgG (97.2%). Sensitivities in descending order were Wantai ELISA total Ab (96.7%), CUH-NOVO in-house ELISA total Ab (96.0%), Ortho Vitros total Ab (95.3%), YHLO iFlash IgG (94.0%), Ortho Vitros IgG (93.3%), Siemens Atellica total Ab (93.2%), Roche Elecsys total Ab (92.7%), Abbott Architect IgG (90.0%), Abbott Alinity IgG (median 88.0%), DiaSorin Liaison XL IgG (median 84.6%), Siemens Vista total Ab (81.0%), Euroimmun/ELISA IgG (78.0%), and Snibe Maglumi IgG (median 78.0%). However, confidence intervals overlapped for several assays. The IgM results were variable, with the Wantai IgM ELISA showing the highest sensitivity (82.7%) and specificity (99%). The rate of seropositivity increased with time from symptom onset and symptom severity.",
keywords = "SARS-CoV-2 antibody test, anti-SARS-CoV-2 serology assay, evaluation, Evaluation, Anti-SARS-CoV-2 serology assay",
author = "Harritsh{\o}j, {Lene H} and Mikkel Gybel-Brask and Shoaib Afzal and Kamstrup, {Pia R} and J{\o}rgensen, {Charlotte S} and Thomsen, {Marianne Kragh} and Linda Hilsted and Lennart Friis-Hansen and Szecsi, {Pal B} and Lise Pedersen and Lene Nielsen and Hansen, {Cecilie B} and Peter Garred and Trine-Line Korsholm and Susan Mikkelsen and Nielsen, {Kirstine O} and M{\o}ller, {Bjarne K} and Hansen, {Anne T} and Iversen, {Kasper K} and Nielsen, {Pernille B} and Hasselbalch, {Rasmus B} and Kamille Fogh and Norsk, {Jakob B} and Kristensen, {Jonas Henrik} and Kristian Sch{\o}nning and Kirkby, {Nikolai S} and Nielsen, {Alex C Y} and Landsy, {Lone H} and Mette Loftager and Holm, {Dorte K} and Nilsson, {Anna C} and S{\ae}kmose, {Susanne G} and Birgitte Grum-Schwensen and Bitten Aagaard and Jensen, {Th{\o}ger G} and Nielsen, {Dorte M} and Henrik Ullum and Dessau, {Ram B C}",
note = "Copyright {\textcopyright} 2021 American Society for Microbiology.",
year = "2021",
month = may,
doi = "10.1128/JCM.02596-20",
language = "English",
volume = "59",
journal = "Journal of Clinical Microbiology",
issn = "0095-1137",
publisher = "American Society for Microbiology",
number = "5",

}

RIS

TY - JOUR

T1 - Comparison of 16 Serological SARS-CoV-2 Immunoassays in 16 Clinical Laboratories

AU - Harritshøj, Lene H

AU - Gybel-Brask, Mikkel

AU - Afzal, Shoaib

AU - Kamstrup, Pia R

AU - Jørgensen, Charlotte S

AU - Thomsen, Marianne Kragh

AU - Hilsted, Linda

AU - Friis-Hansen, Lennart

AU - Szecsi, Pal B

AU - Pedersen, Lise

AU - Nielsen, Lene

AU - Hansen, Cecilie B

AU - Garred, Peter

AU - Korsholm, Trine-Line

AU - Mikkelsen, Susan

AU - Nielsen, Kirstine O

AU - Møller, Bjarne K

AU - Hansen, Anne T

AU - Iversen, Kasper K

AU - Nielsen, Pernille B

AU - Hasselbalch, Rasmus B

AU - Fogh, Kamille

AU - Norsk, Jakob B

AU - Kristensen, Jonas Henrik

AU - Schønning, Kristian

AU - Kirkby, Nikolai S

AU - Nielsen, Alex C Y

AU - Landsy, Lone H

AU - Loftager, Mette

AU - Holm, Dorte K

AU - Nilsson, Anna C

AU - Sækmose, Susanne G

AU - Grum-Schwensen, Birgitte

AU - Aagaard, Bitten

AU - Jensen, Thøger G

AU - Nielsen, Dorte M

AU - Ullum, Henrik

AU - Dessau, Ram B C

N1 - Copyright © 2021 American Society for Microbiology.

PY - 2021/5

Y1 - 2021/5

N2 - Serological assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are needed to support clinical diagnosis and epidemiological investigations. Recently, assays for large-scale detection of total antibodies (Ab), immunoglobulin G (IgG), and IgM against SARS-CoV-2 antigens have been developed, but there are limited data on the diagnostic accuracy of these assays. This study was a Danish national collaboration and evaluated 15 commercial and one in-house anti-SARS-CoV-2 assays in 16 laboratories. Sensitivity was evaluated using 150 samples from individuals with asymptomatic, mild, or moderate COVID-19, nonhospitalized or hospitalized, confirmed by nucleic acid amplification tests (NAAT); samples were collected 13 to 73 days either from symptom onset or from positive NAAT (patients without symptoms). Specificity and cross-reactivity were evaluated in samples collected prior to the SARS-CoV-2 epidemic from >586 blood donors and patients with autoimmune diseases, cytomegalovirus or Epstein-Barr virus infections, and acute viral infections. A specificity of ≥99% was achieved by all total-Ab and IgG assays except one, DiaSorin Liaison XL IgG (97.2%). Sensitivities in descending order were Wantai ELISA total Ab (96.7%), CUH-NOVO in-house ELISA total Ab (96.0%), Ortho Vitros total Ab (95.3%), YHLO iFlash IgG (94.0%), Ortho Vitros IgG (93.3%), Siemens Atellica total Ab (93.2%), Roche Elecsys total Ab (92.7%), Abbott Architect IgG (90.0%), Abbott Alinity IgG (median 88.0%), DiaSorin Liaison XL IgG (median 84.6%), Siemens Vista total Ab (81.0%), Euroimmun/ELISA IgG (78.0%), and Snibe Maglumi IgG (median 78.0%). However, confidence intervals overlapped for several assays. The IgM results were variable, with the Wantai IgM ELISA showing the highest sensitivity (82.7%) and specificity (99%). The rate of seropositivity increased with time from symptom onset and symptom severity.

AB - Serological assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are needed to support clinical diagnosis and epidemiological investigations. Recently, assays for large-scale detection of total antibodies (Ab), immunoglobulin G (IgG), and IgM against SARS-CoV-2 antigens have been developed, but there are limited data on the diagnostic accuracy of these assays. This study was a Danish national collaboration and evaluated 15 commercial and one in-house anti-SARS-CoV-2 assays in 16 laboratories. Sensitivity was evaluated using 150 samples from individuals with asymptomatic, mild, or moderate COVID-19, nonhospitalized or hospitalized, confirmed by nucleic acid amplification tests (NAAT); samples were collected 13 to 73 days either from symptom onset or from positive NAAT (patients without symptoms). Specificity and cross-reactivity were evaluated in samples collected prior to the SARS-CoV-2 epidemic from >586 blood donors and patients with autoimmune diseases, cytomegalovirus or Epstein-Barr virus infections, and acute viral infections. A specificity of ≥99% was achieved by all total-Ab and IgG assays except one, DiaSorin Liaison XL IgG (97.2%). Sensitivities in descending order were Wantai ELISA total Ab (96.7%), CUH-NOVO in-house ELISA total Ab (96.0%), Ortho Vitros total Ab (95.3%), YHLO iFlash IgG (94.0%), Ortho Vitros IgG (93.3%), Siemens Atellica total Ab (93.2%), Roche Elecsys total Ab (92.7%), Abbott Architect IgG (90.0%), Abbott Alinity IgG (median 88.0%), DiaSorin Liaison XL IgG (median 84.6%), Siemens Vista total Ab (81.0%), Euroimmun/ELISA IgG (78.0%), and Snibe Maglumi IgG (median 78.0%). However, confidence intervals overlapped for several assays. The IgM results were variable, with the Wantai IgM ELISA showing the highest sensitivity (82.7%) and specificity (99%). The rate of seropositivity increased with time from symptom onset and symptom severity.

KW - SARS-CoV-2 antibody test

KW - anti-SARS-CoV-2 serology assay

KW - evaluation

KW - Evaluation

KW - Anti-SARS-CoV-2 serology assay

UR - http://www.scopus.com/inward/record.url?scp=85105112647&partnerID=8YFLogxK

U2 - 10.1128/JCM.02596-20

DO - 10.1128/JCM.02596-20

M3 - Journal article

C2 - 33574119

VL - 59

JO - Journal of Clinical Microbiology

JF - Journal of Clinical Microbiology

SN - 0095-1137

IS - 5

M1 - e02596-20

ER -

ID: 62295306