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Evaluation of 32 rapid tests for detection of antibodies against SARS-CoV-2

AIMS: To evaluate the analytical performance of 32 rapid tests for detection of antibodies against coronavirus SARS-CoV-2. MATERIALS AND METHODS: We used at total of 262 serum samples (197 pre-pandemic and 65 convalescent COVID-19), and three criteria to evaluate the rapid tests under standardized a...

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Autores principales: Tollånes, Mette C., Jenum, Pål A., Kierkegaard, Helene, Abildsnes, Eirik, Bævre-Jensen, Roar Magne, Breivik, Anne C., Sandberg, Sverre
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier B.V. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8078036/
https://www.ncbi.nlm.nih.gov/pubmed/33930425
http://dx.doi.org/10.1016/j.cca.2021.04.016
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author Tollånes, Mette C.
Jenum, Pål A.
Kierkegaard, Helene
Abildsnes, Eirik
Bævre-Jensen, Roar Magne
Breivik, Anne C.
Sandberg, Sverre
author_facet Tollånes, Mette C.
Jenum, Pål A.
Kierkegaard, Helene
Abildsnes, Eirik
Bævre-Jensen, Roar Magne
Breivik, Anne C.
Sandberg, Sverre
author_sort Tollånes, Mette C.
collection PubMed
description AIMS: To evaluate the analytical performance of 32 rapid tests for detection of antibodies against coronavirus SARS-CoV-2. MATERIALS AND METHODS: We used at total of 262 serum samples (197 pre-pandemic and 65 convalescent COVID-19), and three criteria to evaluate the rapid tests under standardized and optimal conditions: (i) Immunoglobulin G (IgG) specificity “good” if lower limit of the 95% confidence interval was ≥ 97.0%, “acceptable” if point estimate was ≥ 97.0%, otherwise “not acceptable”. (ii) IgG sensitivity “good” if point estimate was ≥ 90.0%, “acceptable” if ≥ 85.0%, otherwise “not acceptable”. (iii) User-friendliness “not acceptable” if complicated to perform or difficult to read result, otherwise “good”. We also included partial evaluations of three automated immunoassay systems. RESULTS: Sensitivity and specificity varied considerably; IgG specificity between 90.9% (85.9–94.2) and 100% (97.7–100.0), and IgG sensitivity between 53.8% (41.9–65.4) and 98.5% (91.0–100.0). Combining our evaluation criteria, none of the 28 rapid tests that detected IgG had an overall performance considered “good”, seven tests were considered “acceptable”, while 21 tests were considered “not acceptable”. Four tests detected only total antibodies and were not given an overall evaluation. IgG sensitivity and/or specificity of the automated immunoassays did not exceed that of many rapid tests. CONCLUSION: When prevalence is low, the most important analytical property is a test’s IgG specificity, which must be high to minimize false positive results. Out of 32 rapid tests, none had a performance classified as “good”, but seven were classified as “acceptable”.
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spelling pubmed-80780362021-04-28 Evaluation of 32 rapid tests for detection of antibodies against SARS-CoV-2 Tollånes, Mette C. Jenum, Pål A. Kierkegaard, Helene Abildsnes, Eirik Bævre-Jensen, Roar Magne Breivik, Anne C. Sandberg, Sverre Clin Chim Acta Article AIMS: To evaluate the analytical performance of 32 rapid tests for detection of antibodies against coronavirus SARS-CoV-2. MATERIALS AND METHODS: We used at total of 262 serum samples (197 pre-pandemic and 65 convalescent COVID-19), and three criteria to evaluate the rapid tests under standardized and optimal conditions: (i) Immunoglobulin G (IgG) specificity “good” if lower limit of the 95% confidence interval was ≥ 97.0%, “acceptable” if point estimate was ≥ 97.0%, otherwise “not acceptable”. (ii) IgG sensitivity “good” if point estimate was ≥ 90.0%, “acceptable” if ≥ 85.0%, otherwise “not acceptable”. (iii) User-friendliness “not acceptable” if complicated to perform or difficult to read result, otherwise “good”. We also included partial evaluations of three automated immunoassay systems. RESULTS: Sensitivity and specificity varied considerably; IgG specificity between 90.9% (85.9–94.2) and 100% (97.7–100.0), and IgG sensitivity between 53.8% (41.9–65.4) and 98.5% (91.0–100.0). Combining our evaluation criteria, none of the 28 rapid tests that detected IgG had an overall performance considered “good”, seven tests were considered “acceptable”, while 21 tests were considered “not acceptable”. Four tests detected only total antibodies and were not given an overall evaluation. IgG sensitivity and/or specificity of the automated immunoassays did not exceed that of many rapid tests. CONCLUSION: When prevalence is low, the most important analytical property is a test’s IgG specificity, which must be high to minimize false positive results. Out of 32 rapid tests, none had a performance classified as “good”, but seven were classified as “acceptable”. Elsevier B.V. 2021-08 2021-04-27 /pmc/articles/PMC8078036/ /pubmed/33930425 http://dx.doi.org/10.1016/j.cca.2021.04.016 Text en © 2021 Elsevier B.V. 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
Tollånes, Mette C.
Jenum, Pål A.
Kierkegaard, Helene
Abildsnes, Eirik
Bævre-Jensen, Roar Magne
Breivik, Anne C.
Sandberg, Sverre
Evaluation of 32 rapid tests for detection of antibodies against SARS-CoV-2
title Evaluation of 32 rapid tests for detection of antibodies against SARS-CoV-2
title_full Evaluation of 32 rapid tests for detection of antibodies against SARS-CoV-2
title_fullStr Evaluation of 32 rapid tests for detection of antibodies against SARS-CoV-2
title_full_unstemmed Evaluation of 32 rapid tests for detection of antibodies against SARS-CoV-2
title_short Evaluation of 32 rapid tests for detection of antibodies against SARS-CoV-2
title_sort evaluation of 32 rapid tests for detection of antibodies against sars-cov-2
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8078036/
https://www.ncbi.nlm.nih.gov/pubmed/33930425
http://dx.doi.org/10.1016/j.cca.2021.04.016
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