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Lessons learned: A look back at the performance of nine COVID-19 serologic assays and their proposed utility
BACKGROUND: Serologic assays for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been proposed to assist with the acute diagnosis of infection, support epidemiological studies, identify convalescent plasma donors, and evaluate vaccine response. METHODS: We report an evaluation...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
The Canadian Society of Clinical Chemists. Published by Elsevier Inc.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9985916/ https://www.ncbi.nlm.nih.gov/pubmed/36878344 http://dx.doi.org/10.1016/j.clinbiochem.2023.03.003 |
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author | Tolan, Nicole V. DeSimone, Mia S Fernandes, Maria D Lewis, Joshua E. Simmons, Daimon P Schur, Peter H Brigl, Manfred Tanasijevic, Milenko J Desjardins, Michaël Sherman, Amy C Baden, Lindsey R Snyder, Marion Melanson, Stacy EF |
author_facet | Tolan, Nicole V. DeSimone, Mia S Fernandes, Maria D Lewis, Joshua E. Simmons, Daimon P Schur, Peter H Brigl, Manfred Tanasijevic, Milenko J Desjardins, Michaël Sherman, Amy C Baden, Lindsey R Snyder, Marion Melanson, Stacy EF |
author_sort | Tolan, Nicole V. |
collection | PubMed |
description | BACKGROUND: Serologic assays for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been proposed to assist with the acute diagnosis of infection, support epidemiological studies, identify convalescent plasma donors, and evaluate vaccine response. METHODS: We report an evaluation of nine serologic assays: Abbott (AB) and Epitope (EP) IgG and IgM, EUROIMMUN (EU) IgG and IgA, Roche anti-N (RN TOT) and anti-S (RS TOT) total antibody, and DiaSorin (DS) IgG. We evaluated 291 negative controls (NEG CTRL), 91 PCR positive (PCR POS) patients (179 samples), 126 convalescent plasma donors (CPD), 27 healthy vaccinated donors (VD), and 20 allogeneic hematopoietic stem cell transplant (HSCT) recipients (45 samples). RESULTS: We observed good agreement with the method performance claims for specificity (93–100%) in NEG CTRL but only 85% for EU IgA. The sensitivity claims in the first 2 weeks of symptom onset was lower (26–61%) than performance claims based on > 2 weeks since PCR positivity. We observed high sensitivities (94–100%) in CPD except for AB IgM (77%), EP IgM (0%). Significantly higher RS TOT was observed for Moderna vaccine recipients then Pfizer (p-values < 0.0001). A sustained RS TOT response was observed for the five months following vaccination. HSCT recipients demonstrated significantly lower RS TOT than healthy VD (p < 0.0001) at dose 2 and 4 weeks after. CONCLUSIONS: Our data suggests against the use of anti-SARS-CoV-2 assays to aid in acute diagnosis. RN TOT and RS TOT can readily identify past-resolved infection and vaccine response in the absence of native infection. We provide an estimate of expected antibody response in healthy VD over the time course of vaccination for which to compare antibody responses in immunosuppressed patients. |
format | Online Article Text |
id | pubmed-9985916 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | The Canadian Society of Clinical Chemists. Published by Elsevier Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-99859162023-03-06 Lessons learned: A look back at the performance of nine COVID-19 serologic assays and their proposed utility Tolan, Nicole V. DeSimone, Mia S Fernandes, Maria D Lewis, Joshua E. Simmons, Daimon P Schur, Peter H Brigl, Manfred Tanasijevic, Milenko J Desjardins, Michaël Sherman, Amy C Baden, Lindsey R Snyder, Marion Melanson, Stacy EF Clin Biochem Article BACKGROUND: Serologic assays for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been proposed to assist with the acute diagnosis of infection, support epidemiological studies, identify convalescent plasma donors, and evaluate vaccine response. METHODS: We report an evaluation of nine serologic assays: Abbott (AB) and Epitope (EP) IgG and IgM, EUROIMMUN (EU) IgG and IgA, Roche anti-N (RN TOT) and anti-S (RS TOT) total antibody, and DiaSorin (DS) IgG. We evaluated 291 negative controls (NEG CTRL), 91 PCR positive (PCR POS) patients (179 samples), 126 convalescent plasma donors (CPD), 27 healthy vaccinated donors (VD), and 20 allogeneic hematopoietic stem cell transplant (HSCT) recipients (45 samples). RESULTS: We observed good agreement with the method performance claims for specificity (93–100%) in NEG CTRL but only 85% for EU IgA. The sensitivity claims in the first 2 weeks of symptom onset was lower (26–61%) than performance claims based on > 2 weeks since PCR positivity. We observed high sensitivities (94–100%) in CPD except for AB IgM (77%), EP IgM (0%). Significantly higher RS TOT was observed for Moderna vaccine recipients then Pfizer (p-values < 0.0001). A sustained RS TOT response was observed for the five months following vaccination. HSCT recipients demonstrated significantly lower RS TOT than healthy VD (p < 0.0001) at dose 2 and 4 weeks after. CONCLUSIONS: Our data suggests against the use of anti-SARS-CoV-2 assays to aid in acute diagnosis. RN TOT and RS TOT can readily identify past-resolved infection and vaccine response in the absence of native infection. We provide an estimate of expected antibody response in healthy VD over the time course of vaccination for which to compare antibody responses in immunosuppressed patients. The Canadian Society of Clinical Chemists. Published by Elsevier Inc. 2023-07 2023-03-05 /pmc/articles/PMC9985916/ /pubmed/36878344 http://dx.doi.org/10.1016/j.clinbiochem.2023.03.003 Text en © 2023 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Article Tolan, Nicole V. DeSimone, Mia S Fernandes, Maria D Lewis, Joshua E. Simmons, Daimon P Schur, Peter H Brigl, Manfred Tanasijevic, Milenko J Desjardins, Michaël Sherman, Amy C Baden, Lindsey R Snyder, Marion Melanson, Stacy EF Lessons learned: A look back at the performance of nine COVID-19 serologic assays and their proposed utility |
title | Lessons learned: A look back at the performance of nine COVID-19 serologic assays and their proposed utility |
title_full | Lessons learned: A look back at the performance of nine COVID-19 serologic assays and their proposed utility |
title_fullStr | Lessons learned: A look back at the performance of nine COVID-19 serologic assays and their proposed utility |
title_full_unstemmed | Lessons learned: A look back at the performance of nine COVID-19 serologic assays and their proposed utility |
title_short | Lessons learned: A look back at the performance of nine COVID-19 serologic assays and their proposed utility |
title_sort | lessons learned: a look back at the performance of nine covid-19 serologic assays and their proposed utility |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9985916/ https://www.ncbi.nlm.nih.gov/pubmed/36878344 http://dx.doi.org/10.1016/j.clinbiochem.2023.03.003 |
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