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Test performance evaluation of SARS-CoV-2 serological assays
Appropriate use and interpretation of serological tests for assessments of SARS-CoV-2 exposure, infection and potential immunity require accurate assay performance data. We conducted a head-to-head evaluation of 10 point-of-care (POC) style lateral flow assays (LFAs) and two laboratory-based enzyme-...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7740072/ https://www.ncbi.nlm.nih.gov/pubmed/32855547 http://dx.doi.org/10.1038/s41587-020-0659-0 |
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author | Whitman, Jeffrey D. Hiatt, Joseph Mowery, Cody T. Shy, Brian R. Yu, Ruby Yamamoto, Tori N. Rathore, Ujjwal Goldgof, Gregory M. Whitty, Caroline Woo, Jonathan M. Gallman, Antonia E. Miller, Tyler E. Levine, Andrew G. Nguyen, David N. Bapat, Sagar P. Balcerek, Joanna Bylsma, Sophia A. Lyons, Ana M. Li, Stacy Wong, Allison Wai-yi Gillis-Buck, Eva Mae Steinhart, Zachary B. Lee, Youjin Apathy, Ryan Lipke, Mitchell J. Smith, Jennifer Anne Zheng, Tina Boothby, Ian C. Isaza, Erin Chan, Jackie Acenas, Dante D. Lee, Jinwoo Macrae, Trisha A. Kyaw, Than S. Wu, David Ng, Dianna L. Gu, Wei York, Vanessa A. Eskandarian, Haig Alexander Callaway, Perri C. Warrier, Lakshmi Moreno, Mary E. Levan, Justine Torres, Leonel Farrington, Lila A. Loudermilk, Rita Koshal, Kanishka Zorn, Kelsey C. Garcia-Beltran, Wilfredo F. Yang, Diane Astudillo, Michael G. Bernstein, Bradley E. Gelfand, Jeffrey A. Ryan, Edward T. Charles, Richelle C. Iafrate, A. John Lennerz, Jochen K. Miller, Steve Chiu, Charles Y. Stramer, Susan L. Wilson, Michael R. Manglik, Aashish Ye, Chun Jimmie Krogan, Nevan J. Anderson, Mark S. Cyster, Jason G. Ernst, Joel D. Wu, Alan H. B. Lynch, Kara L. Bern, Caryn Hsu, Patrick D. Marson, Alexander |
author_facet | Whitman, Jeffrey D. Hiatt, Joseph Mowery, Cody T. Shy, Brian R. Yu, Ruby Yamamoto, Tori N. Rathore, Ujjwal Goldgof, Gregory M. Whitty, Caroline Woo, Jonathan M. Gallman, Antonia E. Miller, Tyler E. Levine, Andrew G. Nguyen, David N. Bapat, Sagar P. Balcerek, Joanna Bylsma, Sophia A. Lyons, Ana M. Li, Stacy Wong, Allison Wai-yi Gillis-Buck, Eva Mae Steinhart, Zachary B. Lee, Youjin Apathy, Ryan Lipke, Mitchell J. Smith, Jennifer Anne Zheng, Tina Boothby, Ian C. Isaza, Erin Chan, Jackie Acenas, Dante D. Lee, Jinwoo Macrae, Trisha A. Kyaw, Than S. Wu, David Ng, Dianna L. Gu, Wei York, Vanessa A. Eskandarian, Haig Alexander Callaway, Perri C. Warrier, Lakshmi Moreno, Mary E. Levan, Justine Torres, Leonel Farrington, Lila A. Loudermilk, Rita Koshal, Kanishka Zorn, Kelsey C. Garcia-Beltran, Wilfredo F. Yang, Diane Astudillo, Michael G. Bernstein, Bradley E. Gelfand, Jeffrey A. Ryan, Edward T. Charles, Richelle C. Iafrate, A. John Lennerz, Jochen K. Miller, Steve Chiu, Charles Y. Stramer, Susan L. Wilson, Michael R. Manglik, Aashish Ye, Chun Jimmie Krogan, Nevan J. Anderson, Mark S. Cyster, Jason G. Ernst, Joel D. Wu, Alan H. B. Lynch, Kara L. Bern, Caryn Hsu, Patrick D. Marson, Alexander |
author_sort | Whitman, Jeffrey D. |
collection | PubMed |
description | Appropriate use and interpretation of serological tests for assessments of SARS-CoV-2 exposure, infection and potential immunity require accurate assay performance data. We conducted a head-to-head evaluation of 10 point-of-care (POC) style lateral flow assays (LFAs) and two laboratory-based enzyme-linked immunosorbent assays (ELISAs) to detect anti-SARS-CoV-2 IgM and IgG antibodies by 5-day time intervals from symptom onset and the specificity of each assay in pre-COVID-2019 specimens. The percent of seropositive individuals increased with time, peaking in the latest time interval tested (>20 days after symptom onset). Test specificity was heterogeneous (ranging from 84.3–100.0%) and was predominantly affected by variability in IgM results. LFA specificity could be increased by considering weak bands as negative, but this decreased detection of antibodies in a subset of SARS-CoV-2 real-time polymerase chain reaction (RT-PCR)-positive cases. Our results indicate the importance of seropositivity threshold determination and reader training for reliable LFA deployment. Informed use of serology will require evaluations covering the full spectrum of SARS-CoV-2 infections, from asymptomatic and mild infection to severe disease, and later convalescence. Well-designed studies to elucidate the mechanisms and serological correlates of protective immunity will be crucial to guide rational clinical and public health policies. |
format | Online Article Text |
id | pubmed-7740072 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
record_format | MEDLINE/PubMed |
spelling | pubmed-77400722021-02-27 Test performance evaluation of SARS-CoV-2 serological assays Whitman, Jeffrey D. Hiatt, Joseph Mowery, Cody T. Shy, Brian R. Yu, Ruby Yamamoto, Tori N. Rathore, Ujjwal Goldgof, Gregory M. Whitty, Caroline Woo, Jonathan M. Gallman, Antonia E. Miller, Tyler E. Levine, Andrew G. Nguyen, David N. Bapat, Sagar P. Balcerek, Joanna Bylsma, Sophia A. Lyons, Ana M. Li, Stacy Wong, Allison Wai-yi Gillis-Buck, Eva Mae Steinhart, Zachary B. Lee, Youjin Apathy, Ryan Lipke, Mitchell J. Smith, Jennifer Anne Zheng, Tina Boothby, Ian C. Isaza, Erin Chan, Jackie Acenas, Dante D. Lee, Jinwoo Macrae, Trisha A. Kyaw, Than S. Wu, David Ng, Dianna L. Gu, Wei York, Vanessa A. Eskandarian, Haig Alexander Callaway, Perri C. Warrier, Lakshmi Moreno, Mary E. Levan, Justine Torres, Leonel Farrington, Lila A. Loudermilk, Rita Koshal, Kanishka Zorn, Kelsey C. Garcia-Beltran, Wilfredo F. Yang, Diane Astudillo, Michael G. Bernstein, Bradley E. Gelfand, Jeffrey A. Ryan, Edward T. Charles, Richelle C. Iafrate, A. John Lennerz, Jochen K. Miller, Steve Chiu, Charles Y. Stramer, Susan L. Wilson, Michael R. Manglik, Aashish Ye, Chun Jimmie Krogan, Nevan J. Anderson, Mark S. Cyster, Jason G. Ernst, Joel D. Wu, Alan H. B. Lynch, Kara L. Bern, Caryn Hsu, Patrick D. Marson, Alexander Nat Biotechnol Article Appropriate use and interpretation of serological tests for assessments of SARS-CoV-2 exposure, infection and potential immunity require accurate assay performance data. We conducted a head-to-head evaluation of 10 point-of-care (POC) style lateral flow assays (LFAs) and two laboratory-based enzyme-linked immunosorbent assays (ELISAs) to detect anti-SARS-CoV-2 IgM and IgG antibodies by 5-day time intervals from symptom onset and the specificity of each assay in pre-COVID-2019 specimens. The percent of seropositive individuals increased with time, peaking in the latest time interval tested (>20 days after symptom onset). Test specificity was heterogeneous (ranging from 84.3–100.0%) and was predominantly affected by variability in IgM results. LFA specificity could be increased by considering weak bands as negative, but this decreased detection of antibodies in a subset of SARS-CoV-2 real-time polymerase chain reaction (RT-PCR)-positive cases. Our results indicate the importance of seropositivity threshold determination and reader training for reliable LFA deployment. Informed use of serology will require evaluations covering the full spectrum of SARS-CoV-2 infections, from asymptomatic and mild infection to severe disease, and later convalescence. Well-designed studies to elucidate the mechanisms and serological correlates of protective immunity will be crucial to guide rational clinical and public health policies. 2020-08-27 2020-10 /pmc/articles/PMC7740072/ /pubmed/32855547 http://dx.doi.org/10.1038/s41587-020-0659-0 Text en Users may view, print, copy, and download text and data-mine the content in such documents, for the purposes of academic research, subject always to the full Conditions of use:http://www.nature.com/authors/editorial_policies/license.html#terms |
spellingShingle | Article Whitman, Jeffrey D. Hiatt, Joseph Mowery, Cody T. Shy, Brian R. Yu, Ruby Yamamoto, Tori N. Rathore, Ujjwal Goldgof, Gregory M. Whitty, Caroline Woo, Jonathan M. Gallman, Antonia E. Miller, Tyler E. Levine, Andrew G. Nguyen, David N. Bapat, Sagar P. Balcerek, Joanna Bylsma, Sophia A. Lyons, Ana M. Li, Stacy Wong, Allison Wai-yi Gillis-Buck, Eva Mae Steinhart, Zachary B. Lee, Youjin Apathy, Ryan Lipke, Mitchell J. Smith, Jennifer Anne Zheng, Tina Boothby, Ian C. Isaza, Erin Chan, Jackie Acenas, Dante D. Lee, Jinwoo Macrae, Trisha A. Kyaw, Than S. Wu, David Ng, Dianna L. Gu, Wei York, Vanessa A. Eskandarian, Haig Alexander Callaway, Perri C. Warrier, Lakshmi Moreno, Mary E. Levan, Justine Torres, Leonel Farrington, Lila A. Loudermilk, Rita Koshal, Kanishka Zorn, Kelsey C. Garcia-Beltran, Wilfredo F. Yang, Diane Astudillo, Michael G. Bernstein, Bradley E. Gelfand, Jeffrey A. Ryan, Edward T. Charles, Richelle C. Iafrate, A. John Lennerz, Jochen K. Miller, Steve Chiu, Charles Y. Stramer, Susan L. Wilson, Michael R. Manglik, Aashish Ye, Chun Jimmie Krogan, Nevan J. Anderson, Mark S. Cyster, Jason G. Ernst, Joel D. Wu, Alan H. B. Lynch, Kara L. Bern, Caryn Hsu, Patrick D. Marson, Alexander Test performance evaluation of SARS-CoV-2 serological assays |
title | Test performance evaluation of SARS-CoV-2 serological assays |
title_full | Test performance evaluation of SARS-CoV-2 serological assays |
title_fullStr | Test performance evaluation of SARS-CoV-2 serological assays |
title_full_unstemmed | Test performance evaluation of SARS-CoV-2 serological assays |
title_short | Test performance evaluation of SARS-CoV-2 serological assays |
title_sort | test performance evaluation of sars-cov-2 serological assays |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7740072/ https://www.ncbi.nlm.nih.gov/pubmed/32855547 http://dx.doi.org/10.1038/s41587-020-0659-0 |
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