Evaluation of SARS-CoV-2 serology assays reveals a range of test performance.


Journal

Nature biotechnology
ISSN: 1546-1696
Titre abrégé: Nat Biotechnol
Pays: United States
ID NLM: 9604648

Informations de publication

Date de publication:
10 2020
Historique:
received: 09 06 2020
accepted: 29 07 2020
pubmed: 29 8 2020
medline: 21 10 2020
entrez: 29 8 2020
Statut: ppublish

Résumé

Appropriate use and interpretation of serological tests for assessments of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure, infection and potential immunity require accurate data on assay performance. We conducted a head-to-head evaluation of ten point-of-care-style lateral flow assays (LFAs) and two laboratory-based enzyme-linked immunosorbent assays to detect anti-SARS-CoV-2 IgM and IgG antibodies in 5-d time intervals from symptom onset and studied the specificity of each assay in pre-coronavirus disease 2019 specimens. The percent of seropositive individuals increased with time, peaking in the latest time interval tested (>20 d after symptom onset). Test specificity ranged from 84.3% to 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 (sensitivity) in a subset of SARS-CoV-2 real-time PCR-positive cases. Our results underline the importance of seropositivity threshold determination and reader training for reliable LFA deployment. Although there was no standout serological assay, four tests achieved more than 80% positivity at later time points tested and more than 95% specificity.

Identifiants

pubmed: 32855547
doi: 10.1038/s41587-020-0659-0
pii: 10.1038/s41587-020-0659-0
pmc: PMC7740072
mid: NIHMS1616808
doi:

Substances chimiques

Antibodies, Viral 0
Immunoglobulin G 0
Immunoglobulin M 0

Types de publication

Evaluation Study Journal Article Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1174-1183

Subventions

Organisme : NHLBI NIH HHS
ID : R38 HL143581
Pays : United States
Organisme : U.S. Department of Health & Human Services | National Institutes of Health (NIH)
ID : F30AI150061
Pays : International
Organisme : U.S. Department of Health & Human Services | National Institutes of Health (NIH)
ID : T32GM007618
Pays : International
Organisme : U.S. Department of Health & Human Services | National Institutes of Health (NIH)
ID : 1F31NS106868-01
Pays : International
Organisme : NINDS NIH HHS
ID : F31 NS106868
Pays : United States
Organisme : NIAID NIH HHS
ID : F30 AI147364
Pays : United States
Organisme : NIAID NIH HHS
ID : R01 AI040098
Pays : United States
Organisme : NIAID NIH HHS
ID : T32 AI007334
Pays : United States
Organisme : U.S. Department of Health & Human Services | NIH | National Heart, Lung, and Blood Institute (NHLBI)
ID : R38HL143581
Pays : International
Organisme : NIGMS NIH HHS
ID : T32 GM007618
Pays : United States
Organisme : U.S. Department of Health & Human Services | National Institutes of Health (NIH)
ID : 1F30HD093116
Pays : International
Organisme : NIAID NIH HHS
ID : U19 AI135990
Pays : United States
Organisme : NIAID NIH HHS
ID : L40 AI140341
Pays : United States
Organisme : NIAID NIH HHS
ID : F30 AI150061
Pays : United States
Organisme : NCEZID CDC HHS
ID : U01 CK000490
Pays : United States
Organisme : NHLBI NIH HHS
ID : K38 HL154203
Pays : United States
Organisme : ACL HHS
ID : U01CK000490
Pays : United States
Organisme : NICHD NIH HHS
ID : F30 HD093116
Pays : United States

Commentaires et corrections

Type : UpdateOf

Références

Lancet. 2020 May 16;395(10236):1527-1529
pubmed: 32353328
Clin Infect Dis. 2021 Jan 27;72(2):301-308
pubmed: 33501951
Nat Med. 2020 Jul;26(7):1033-1036
pubmed: 32398876
Nat Med. 2020 Jun;26(6):845-848
pubmed: 32350462
Science. 2020 May 1;368(6490):489-493
pubmed: 32179701
Emerg Infect Dis. 2020 Jun;26(6):1341-1343
pubmed: 32191173
JAMA. 2020 May 26;323(20):2085-2086
pubmed: 32293646
Lancet Infect Dis. 2020 Jun;20(6):689-696
pubmed: 32220650
Emerg Infect Dis. 2020 May;26(5):1052-1054
pubmed: 32091386
MMWR Morb Mortal Wkly Rep. 2020 Apr 03;69(13):377-381
pubmed: 32240128
Lancet Infect Dis. 2020 May;20(5):565-574
pubmed: 32213337
JAMA. 2020 May 12;323(18):1843-1844
pubmed: 32159775
Nat Med. 2020 Jun;26(6):849-854
pubmed: 32382154
Viruses. 2020 May 06;12(5):
pubmed: 32384820
Euro Surveill. 2020 Mar;25(10):
pubmed: 32183930
Clin Infect Dis. 2020 Nov 19;71(16):2027-2034
pubmed: 32221519
J Clin Microbiol. 2019 Nov 22;57(12):
pubmed: 31511333
N Engl J Med. 2020 Aug 6;383(6):e37
pubmed: 32501664
Nat Commun. 2020 Sep 17;11(1):4698
pubmed: 32943630
Trends Immunol. 2020 May;41(5):355-359
pubmed: 32249063
Nature. 2020 May;581(7809):465-469
pubmed: 32235945
JAMA. 2020 Apr 14;323(14):1406-1407
pubmed: 32083643
Emerg Microbes Infect. 2020 Dec;9(1):680-686
pubmed: 32207377
Nat Med. 2020 May;26(5):672-675
pubmed: 32296168

Auteurs

Jeffrey D Whitman (JD)

Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, USA.

Joseph Hiatt (J)

Medical Scientist Training Program, University of California, San Francisco, San Francisco, CA, USA.
Biomedical Sciences Graduate Program, University of California, San Francisco, San Francisco, CA, USA.
J. David Gladstone Institutes, San Francisco, CA, USA.
Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
Innovative Genomics Institute, University of California, Berkeley, Berkeley, CA, USA.
Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.

Cody T Mowery (CT)

Medical Scientist Training Program, University of California, San Francisco, San Francisco, CA, USA.
Biomedical Sciences Graduate Program, University of California, San Francisco, San Francisco, CA, USA.
Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
Innovative Genomics Institute, University of California, Berkeley, Berkeley, CA, USA.
Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.

Brian R Shy (BR)

Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, USA.

Ruby Yu (R)

Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.

Tori N Yamamoto (TN)

Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.

Ujjwal Rathore (U)

J. David Gladstone Institutes, San Francisco, CA, USA.
Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
Innovative Genomics Institute, University of California, Berkeley, Berkeley, CA, USA.
Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.

Gregory M Goldgof (GM)

Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, USA.

Caroline Whitty (C)

Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, USA.
Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.

Jonathan M Woo (JM)

Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
Innovative Genomics Institute, University of California, Berkeley, Berkeley, CA, USA.
Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.

Antonia E Gallman (AE)

Medical Scientist Training Program, University of California, San Francisco, San Francisco, CA, USA.
Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
Howard Hughes Medical Institute, University of California, San Francisco, San Francisco, USA.

Tyler E Miller (TE)

Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.

Andrew G Levine (AG)

Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, USA.

David N Nguyen (DN)

Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
Innovative Genomics Institute, University of California, Berkeley, Berkeley, CA, USA.
Department of Medicine, Division of Infectious Diseases, University of California, San Francisco, San Francisco, CA, USA.

Sagar P Bapat (SP)

Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, USA.
Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.

Joanna Balcerek (J)

Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, USA.

Sophia A Bylsma (SA)

Department of Bioengineering, University of California, Berkeley, Berkeley, CA, USA.

Ana M Lyons (AM)

Department of Integrative Biology, University of California, Berkeley, Berkeley, CA, USA.

Stacy Li (S)

Department of Integrative Biology, University of California, Berkeley, Berkeley, CA, USA.

Allison Wai-Yi Wong (AW)

Medical Scientist Training Program, University of California, San Francisco, San Francisco, CA, USA.

Eva Mae Gillis-Buck (EM)

Department of Surgery, University of California, San Francisco, San Francisco, CA, USA.

Zachary B Steinhart (ZB)

Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.

Youjin Lee (Y)

Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.

Ryan Apathy (R)

Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
Innovative Genomics Institute, University of California, Berkeley, Berkeley, CA, USA.
Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.

Mitchell J Lipke (MJ)

Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.

Jennifer Anne Smith (JA)

Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.

Tina Zheng (T)

Medical Scientist Training Program, University of California, San Francisco, San Francisco, CA, USA.
Biomedical Sciences Graduate Program, University of California, San Francisco, San Francisco, CA, USA.
Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.
Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA, USA.

Ian C Boothby (IC)

Medical Scientist Training Program, University of California, San Francisco, San Francisco, CA, USA.
Department of Dermatology, University of California, San Francisco, San Francisco, CA, USA.

Erin Isaza (E)

Medical Scientist Training Program, University of California, San Francisco, San Francisco, CA, USA.
Program in Quantitative Biology, University of California, San Francisco, San Francisco, CA, USA.

Jackie Chan (J)

Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.

Dante D Acenas (DD)

Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.

Jinwoo Lee (J)

Medical Scientist Training Program, University of California, San Francisco, San Francisco, CA, USA.
School of Medicine, University of California, San Francisco, San Francisco, CA, USA.

Trisha A Macrae (TA)

Medical Scientist Training Program, University of California, San Francisco, San Francisco, CA, USA.
School of Medicine, University of California, San Francisco, San Francisco, CA, USA.

Than S Kyaw (TS)

Medical Scientist Training Program, University of California, San Francisco, San Francisco, CA, USA.
Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.

David Wu (D)

Medical Scientist Training Program, University of California, San Francisco, San Francisco, CA, USA.
Biomedical Sciences Graduate Program, University of California, San Francisco, San Francisco, CA, USA.

Dianna L Ng (DL)

Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA, USA.
Department of Pathology, University of California, San Francisco, San Francisco, CA, USA.

Wei Gu (W)

Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, USA.

Vanessa A York (VA)

Division of Experimental Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.

Haig Alexander Eskandarian (HA)

Division of Experimental Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.

Perri C Callaway (PC)

Division of Experimental Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.
Infectious Diseases and Immunity Graduate Group, University of California, Berkeley, Berkeley, CA, USA.

Lakshmi Warrier (L)

Division of Experimental Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.

Mary E Moreno (ME)

Division of Experimental Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.

Justine Levan (J)

Division of Experimental Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.

Leonel Torres (L)

Division of Experimental Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.

Lila A Farrington (LA)

Division of Experimental Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.

Rita P Loudermilk (RP)

Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.

Kanishka Koshal (K)

Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.

Kelsey C Zorn (KC)

Department of Biochemistry and Biophysics, University of California, San Francisco, San Francisco, CA, USA.

Wilfredo F Garcia-Beltran (WF)

Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.

Diane Yang (D)

Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.

Michael G Astudillo (MG)

Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.

Bradley E Bernstein (BE)

Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.

Jeffrey A Gelfand (JA)

Division of Infectious Diseases, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.

Edward T Ryan (ET)

Division of Infectious Diseases, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.

Richelle C Charles (RC)

Division of Infectious Diseases, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.

A John Iafrate (AJ)

Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.

Jochen K Lennerz (JK)

Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.

Steve Miller (S)

Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, USA.

Charles Y Chiu (CY)

Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, USA.
Department of Medicine, Division of Infectious Diseases, University of California, San Francisco, San Francisco, CA, USA.
UCSF-Abbott Viral Diagnostics and Discovery Center, San Francisco, CA, USA.

Susan L Stramer (SL)

Scientific Affairs, American Red Cross, Gaithersburg, MD, USA.

Michael R Wilson (MR)

Biomedical Sciences Graduate Program, University of California, San Francisco, San Francisco, CA, USA.
Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.

Aashish Manglik (A)

Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco, CA, USA.
Department of Pharmaceutical Chemistry, University of California, San Francisco, San Francisco, CA, USA.

Chun Jimmie Ye (CJ)

Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA.
Chan Zuckerberg Biohub, San Francisco, CA, USA.
Institute for Human Genetics, University of California, San Francisco, San Francisco, CA, USA.
Division of Rheumatology, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.
Institute of Computational Health Sciences, University of California, San Francisco, San Francisco, CA, USA.
Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, USA.

Nevan J Krogan (NJ)

J. David Gladstone Institutes, San Francisco, CA, USA.
Department of Cellular and Molecular Pharmacology, University of California, San Francisco, San Francisco, CA, USA.
Quantitative Biosciences Institute, University of California, San Francisco, San Francisco, CA, USA.

Mark S Anderson (MS)

Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.

Jason G Cyster (JG)

Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
Howard Hughes Medical Institute, University of California, San Francisco, San Francisco, USA.

Joel D Ernst (JD)

Division of Experimental Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.

Alan H B Wu (AHB)

Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, USA.

Kara L Lynch (KL)

Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, USA.

Caryn Bern (C)

Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, USA. caryn.bern2@ucsf.edu.

Patrick D Hsu (PD)

Innovative Genomics Institute, University of California, Berkeley, Berkeley, CA, USA. pdhsu@berkeley.edu.
Department of Bioengineering, University of California, Berkeley, Berkeley, CA, USA. pdhsu@berkeley.edu.
Center for Computational Biology, University of California, Berkeley, Berkeley, CA, USA. pdhsu@berkeley.edu.

Alexander Marson (A)

J. David Gladstone Institutes, San Francisco, CA, USA. alexander.marson@ucsf.edu.
Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA. alexander.marson@ucsf.edu.
Innovative Genomics Institute, University of California, Berkeley, Berkeley, CA, USA. alexander.marson@ucsf.edu.
Diabetes Center, University of California, San Francisco, San Francisco, CA, USA. alexander.marson@ucsf.edu.
Department of Medicine, Division of Infectious Diseases, University of California, San Francisco, San Francisco, CA, USA. alexander.marson@ucsf.edu.
Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA, USA. alexander.marson@ucsf.edu.
Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA. alexander.marson@ucsf.edu.
Chan Zuckerberg Biohub, San Francisco, CA, USA. alexander.marson@ucsf.edu.
Institute for Human Genetics, University of California, San Francisco, San Francisco, CA, USA. alexander.marson@ucsf.edu.
Division of Rheumatology, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA. alexander.marson@ucsf.edu.

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