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Evaluation of SARS-CoV-2 serology assays reveals a range of test performance.
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 P; Koshal, Kanishka; Zorn, Kelsey C; Garcia-Beltran, Wilfredo F; Yang, Diane.
  • Whitman JD; Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, USA.
  • Hiatt J; Medical Scientist Training Program, University of California, San Francisco, San Francisco, CA, USA.
  • Mowery CT; Biomedical Sciences Graduate Program, University of California, San Francisco, San Francisco, CA, USA.
  • Shy BR; J. David Gladstone Institutes, San Francisco, CA, USA.
  • Yu R; Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
  • Yamamoto TN; Innovative Genomics Institute, University of California, Berkeley, Berkeley, CA, USA.
  • Rathore U; Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.
  • Goldgof GM; Medical Scientist Training Program, University of California, San Francisco, San Francisco, CA, USA.
  • Whitty C; Biomedical Sciences Graduate Program, University of California, San Francisco, San Francisco, CA, USA.
  • Woo JM; Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
  • Gallman AE; Innovative Genomics Institute, University of California, Berkeley, Berkeley, CA, USA.
  • Miller TE; Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.
  • Levine AG; Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, USA.
  • Nguyen DN; Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
  • Bapat SP; Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.
  • Balcerek J; Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
  • Bylsma SA; Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.
  • Lyons AM; J. David Gladstone Institutes, San Francisco, CA, USA.
  • Li S; Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
  • Wong AW; Innovative Genomics Institute, University of California, Berkeley, Berkeley, CA, USA.
  • Gillis-Buck EM; Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.
  • Steinhart ZB; Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, USA.
  • Lee Y; Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, USA.
  • Apathy R; Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
  • Lipke MJ; Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.
  • Smith JA; Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
  • Zheng T; Innovative Genomics Institute, University of California, Berkeley, Berkeley, CA, USA.
  • Boothby IC; Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.
  • Isaza E; Medical Scientist Training Program, University of California, San Francisco, San Francisco, CA, USA.
  • Chan J; Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
  • Acenas DD; Howard Hughes Medical Institute, University of California, San Francisco, San Francisco, USA.
  • Lee J; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.
  • Macrae TA; Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, USA.
  • Kyaw TS; Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
  • Wu D; Innovative Genomics Institute, University of California, Berkeley, Berkeley, CA, USA.
  • Ng DL; Department of Medicine, Division of Infectious Diseases, University of California, San Francisco, San Francisco, CA, USA.
  • Gu W; Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, USA.
  • York VA; Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
  • Eskandarian HA; Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.
  • Callaway PC; Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, USA.
  • Warrier L; Department of Bioengineering, University of California, Berkeley, Berkeley, CA, USA.
  • Moreno ME; Department of Integrative Biology, University of California, Berkeley, Berkeley, CA, USA.
  • Levan J; Department of Integrative Biology, University of California, Berkeley, Berkeley, CA, USA.
  • Torres L; Medical Scientist Training Program, University of California, San Francisco, San Francisco, CA, USA.
  • Farrington LA; Department of Surgery, University of California, San Francisco, San Francisco, CA, USA.
  • Loudermilk RP; Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
  • Koshal K; Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.
  • Zorn KC; Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
  • Garcia-Beltran WF; Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
  • Yang D; Innovative Genomics Institute, University of California, Berkeley, Berkeley, CA, USA.
Nat Biotechnol ; 38(10): 1174-1183, 2020 10.
Article in English | MEDLINE | ID: covidwho-733514
ABSTRACT
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Clinical Laboratory Techniques / Betacoronavirus Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: Nat Biotechnol Journal subject: Biotechnology Year: 2020 Document Type: Article Affiliation country: S41587-020-0659-0

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Clinical Laboratory Techniques / Betacoronavirus Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: Nat Biotechnol Journal subject: Biotechnology Year: 2020 Document Type: Article Affiliation country: S41587-020-0659-0